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Look Alike & Sound Alike Medicines: An Emerging Challenge in Patient Safety

July 7, 2025

by official.ajinkya11@gmail.com with No Comment Disease & Drugs

07 July 2025

Category: Patient Safety Initiatives I

Clinical Practice & Prescribing Safety I

Medication Safety

Written By: Dr. Srivatsan Suresh (PharmD)

Around the world, Look Alike & Sound Alike drugs (LASA) are a known source of preventable medication errors. When medications with similar names, packaging, or articulation are mistakenly prescribed, dispensed, or administered, these mistakes happen. The results include life-threatening adverse events or therapeutic failure.

Despite increased use of digital technologies, LASA-related events remain common. A 2021 systematic review reported that medication name confusion is still a major contributor to wrong-drug errors globally. Reducing LASA errors requires system-wide vigilance, training, and safety design in addition to improved labeling.

Case Report Highlights

Tanzania (2024)

In a documented case from Tanzania, a 37-year-old woman undergoing cesarean delivery received tranexamic acid (TXA) intrathecally instead of bupivacaine. It is because the ampoules look similar and are stored in the same surgical drug tray. So within 21 hours, the patient experienced a seizure, severe autonomic disturbances,, and death.

Egypt (2023)

Another case from Egypt involved a 31-year-old male who received 400 mg of TXA intrathecally during surgery. Unlike most such cases, he survived after performing Cerebrospinal fluid (CSF) lavage and ICU care. This highlights the urgent need for redesigning ampoules with distinct visuals.

USA
In multiple U.S. hospitals, Hydroxyzine (an antihistamine) was mistakenly given in place of Hydralazine (an antihypertensive). Both drugs were often stored next to each other in ADCs (automated dispensing cabinets). This prompted the ISMP to recommend separate storage, TallMan lettering, and barcode verification protocols for high-alert LASA medications.

Canada

The Institute for Safe Medication Practices Canada (ISMP Canada) has documented four separate incidents in which lamotrigine (LAMICTAL) was confused with three entirely different medications. In these cases, patients were inadvertently dispensed

Lamivudine (HEPTOVIR), is an antiretroviral agent, Terbinafine HCl (LAMISIL) is an antifungal, and Liothyronine (CYTOMEL) is a thyroid hormone replacement

Each mix-up arises from striking similarities in drug names or packaging, resulting in potentially serious clinical consequences. These reports underscore the imperative for heightened pharmacy verification steps such as Tall Man lettering, barcode scanning, and double‑check systems to catch LASA errors before they reach the patient.

Indian Generic Market as a potential source

The Indian generic pharmaceutical market has inadvertently become a significant source of Look-Alike Sound-Alike (LASA) medication errors. With thousands of manufacturers producing similar formulations under distinct brand names, the risk of phonetic and orthographic confusion is significant. Many generic brands adopt names that closely resemble existing products in an attempt to gain market traction, most of the time without adequate regulatory screening for name uniqueness. This leads to confusion at the prescribing, dispensing, and administration stages, particularly in resource-limited settings where electronic verification tools may be lacking.

Global Trends

According to a 2023 Australian study, LASA drug mix-ups, particularly involving injectables like TXA, dopamine, and local anesthetics, were responsible for 6-15% of preoperative incidents. The study recommended segregated storage procedures and clearer ampoule labeling.

The Lancet (2024) suggested regulatory reform and standardized drug labeling in India. Due to the pharmaceutical industry’s widespread fragmentation, local brands with phonetically similar names were frequently confused, particularly in settings involving oncology and anesthesia.

Tall Man lettering and brand screening should be implemented nationwide immediately after researchers in Thailand examined more than 18,000 brand names and discovered frequent orthographic and phonetic overlaps among commonly prescribed drugs.

Technology-Driven Innovations

AI-Based Pill Recognition

A 2022 AI model, PIMA (Pill Identification via Matching Algorithm), used deep learning and contrastive learning to match pill images to prescriptions. It improved correct identification rates from 19% (human-only review) to 47% using machine learning.

Automated Dispensing Cabinets (ADC)

Selection errors are greatly decreased by modern ADCs when they are set up with barcode scanning and optimal LASA drug placement. According to a 2021 ISMP bulletin, 12% of LASA near-misses were caused by improper cabinet layouts

System Factors behind LASA Errors

A medication error rarely happens due to oversight. The Swiss Cheese Model explains that layers of system failures—like poor labeling, fatigue, or sound-alike names align to allow such errors through.

Some key contributing factors are

Similar packaging or ampoule colour
Inadequate barcode scanning
Distractions or rushed environments
Lack of Tall Man Lettering
Verbal miscommunication or illegible prescriptions

In busy surgical or emergency settings, these issues compound and lead to fatal outcomes.

Prevention Strategies

Tall Man Lettering

Used to highlight differences in similar drug names (eg- vincristine vs. vinblastine), this has been endorsed by the FDA and implemented in many EMR systems.

Barcode and Scanning

Incorporating barcode technology for verification during dispensing and administration reduces manual selection errors significantly.

AI verification tools

Machine learning models like PIMA and image-matching algorithms are being piloted to verify pills, especially in outpatient or home care settings.

Physical separation of LASA drugs

LASA-prone medications need to be kept physically apart, particularly in intensive care units, emergency rooms, and operating rooms.

Standardized protocols and training

Verifying twice while preparing and administering
Regular training includes LASA case studies
Simulation studies are required when approving new drugs

Regulatory and Institutional Efforts

WHO (2023)

Issued updated safety alerts following a cluster of fatal TXA intrathecal administrations in low-resource settings.

FDA (2022)

Reinforced the use of Name Simulation Studies as a regulatory step before drug approval, aimed at preventing new LASA names from entering the market

ISMP (2021-2023)

Maintains publishing and updating LASA watch lists, near-miss reports, and instructions for reorganizing medicine storage and ampoule labeling.

JCI’s Role in LASA Error Prevention

The Joint Commission International (JCI) is a globally recognized healthcare accreditation body that sets rigorous standards for patient safety and quality of care. It supports hospitals and health systems worldwide in improving clinical practices, including medication safety and LASA error prevention.

International Patient Safety Goals (IPSG 3) included standard practice to improve the safety of high-alert medications under this goal; JCI specifically emphasizes the identification and management of LASA medications.

Accredited hospitals are required to maintain an active list of LASA drugs, assess risk potential, and implement preventive strategies such as the following:

Tall Man lettering
Color-coded labels
Separate storage
Staff education and the LASA drill

JCI mandates that organizations implement Medication Management and Use (MMU) protocols, which include:

A documented LASA risk reduction strategy
Use of double-verification systems in dispensing and administration
Periodic audits and incident tracking of LASA errors

JCI provides toolkits and reference guidelines for identifying LASA pairs during formulary reviews and encourages the use of international LASA watch lists

Conclusion

One of the biggest risks to patient safety is still LASA medication errors, particularly in high-stakes settings like critical care, oncology, and surgery. These errors could be reduced by combining smart storage systems, training, modern technologies, and regulatory reform.

The key lies in redundancy: no single tool or strategy is enough. Systems need to be built to fail safely, identifying mistakes before they affect the patient. We can eliminate LASA errors with the correct tool investment and attention to detail.

References

Bryan R, Aronson JK, Williams AJ, Jordan S. A systematic literature review of LASA error interventions. British Journal of Clinical Pharmacology, 2020 Nov 16; 87(2):336–51.

Samuel RO, Adonicam V, Mgaya AH, Accidental intrathecal tranexamic acid injection during cesarean section: A case report. Case Reports in Anesthesiology, 2024 Jan 1; 2024(1).

Harby SA, Kohaf NA. Accidental intrathecal injection of tranexamic acid: a case report. Journal of Medical Case Reports, 2023 Feb 16; 17(1).

Hydralazine, Hydroxyzine Confused Again, America’s PHARMACIST | October 2016, Institute for Safe Medication Practices (ISMP), https://www.ncpa.co/issues/APOCT16-MedSafety.pdf

Hydroxyzine and Hydralazine Mix-Ups, Pennsylvania Patient Safety Advisory, Patient Safety Authority, https://patientsafety.pa.gov/ADVISORIES/Pages/200606_21.aspx

Ryan AN, Robertson KL, Glass BD. Look-Alike, Sound-Alike Medication Perioperative Incidents in a Regional Australian Hospital: Assessment using a Novel Medication Safety Culture Assessment Tool. International Journal for Quality in Health Care. 2025 Mar 3;

Neelakantan M, Association for Socially Applicable Research (ASAR), Pune, Maharashtra, India, Department of Community Medicine, Maulana Azad Medical College, New Delhi, India, Independent Economist, India. Look-alike, sound-alike (LASA) drugs in India. Vol. 26, the Lancet Regional Health – Southeast Asia, 2024, p. 100425

Wikipedia contributors, Tall Man lettering, Wikipedia, 2024

Nguyen TT, Nguyen HD, Nguyen TH, Pham HH, Ide I, Nguyen PL, A Novel Approach for Pill-Prescription Matching with GNN Assistance and Contrastive Learning, arXiv.org. 2022

Acute care, ECRI, and ISMP, 2024

Meyer TA, McAllister RK. Medication Errors Related to Look-Alike, Sound-Alike Drugs—How Big is the Problem and What Progress is Being Made? Vol. 38, APSF Newsletter. 2023 p. 2–49

WHO. (2023). Intrathecal TXA Global Alert

Office of the Commissioner, Modeling & Simulation at FDA [Internet], U.S. Food And Drug Administration. 2022.

Dhande PP, Mule AV, Chaudhari AP. Retrospective analysis of look-alike and sound-alike drug incidents in a tertiary care hospital. Indian Journal of Pharmacy Practice 2021 Apr 15;14(2):114–7.

Standards Interpretation FAQs, IPSG-3, Joint Commission International, https://www.jointcommissioninternational.org/-/media/jci/jci-documents/contact-us/submit-a-jci-standards-interpretation-question/jci_standards_interpretation_faqs.pdf

Multiple Reports of Confusion Between Lamotrigine (LAMICTAL®) and Products with ‘sound alike’ / ‘look alike’ Names, ISMP Canada Safety Bulletin, ISMP Canada, December 2001, Vol 1, Issue 3

Dr. Srivatsan Suresh is a Pharm.D. graduate with a focused background in clinical research, pharmacovigilance, and regulatory science. Adept at synthesizing clinical data into clear, compliant medical content. Passionate about medical writing as a strategic tool to support regulatory submissions, healthcare communication, and scientific publications in a fast-paced industry setting.

Health Benefits of Tinospora Cordifolia (Guduchi /Giloy/Gulvel)

July 6, 2025

by official.ajinkya11@gmail.com with No Comment Wellness

06 July 2025

Category: Ayurvedic & Integrative Therapeutics I

Traditional Medicine in Modern Health Research

Written By:

Shweta Rajguru (PharmD, purs.)

Reviewed By:

Ayurvedacharya

Dr. Gaurav Pahare BAMS

Guduchi, also known as Gulvel and Tinospora cordifolia in scientific nomenclature, is a large, smooth, deciduous climbing shrub in the Menispermaceae family. It is considered to be “Rasayana,” a rejuvenator in Ayurvedic medicine, also referred to as “Amrita” (the nectar of immortality). Guduchi has many names, including Amritavalli, Madhuparni, Guduchika, Chinnobhava, Vatsadani, Tantrika, and Kundalini. The Sanskrit name of this shrub, Guduchi, literally means ‘one that protects the entire body.’ Medicinally, the stem of Guduchi is the most widely used part of the shrub, valued for its high concentration of bioactive compounds; however, the roots and leaves are also utilized in some traditional preparations. Guduchi has long been used for its wide range of health benefits, from boosting immunity to reducing inflammation. In recent decades, modern pharmacological research has begun validating many of these traditional claims.

Health Benefits of Guduchi

Immunomodulatory Effects

Guduchi is renowned for its ability to boost immune function. The immune-stimulating potential of Guduchi (Tinospora cordifolia) has been well documented through recent scientific research. The stem of Guduchi was found to significantly enhance the immune response by promoting the secretion of key pro-inflammatory cytokines, including IFN-γ, TNF-α, and IL-1β, by murine macrophages, increasing phagocytic activity, and modulating cytokine production. It was notably used as an immune booster during the COVID-19 pandemic in several integrative medicine protocols in the Indian subcontinent.

Antipyretic and Anti-inflammatory Properties

Guduchi has shown significant anti-inflammatory and antipyretic effects in animal studies. Its aqueous stem extract reduced inflammation and fever comparably to diclofenac and paracetamol. The observed effects are believed to result from the dual inhibition of cyclooxygenase (COX) and lipoxygenase (LOX) pathways, key players in the inflammatory cascade. Furthermore, the presence of flavonoids, alkaloids, and protoberberine compounds in the extract is thought to contribute to the suppression of prostaglandin synthesis and modulation of pyrogenic cytokines. Some ghee-based formulations, like Guduchi Ghrita, also showed antipyretic activity.

Anti-diabetic Effects

Some studies evaluate and support the antidiabetic claims of Tinospora cordifolia, emphasizing its preventive, curative, and restorative potential in managing diabetes and its complications. Research highlights multiple mechanisms of action, including improvement of insulin secretion, enhanced insulin sensitivity, inhibition of α-glucosidase and α-amylase, modulation of glucose metabolism, suppression of oxidative stress, and immunomodulatory effects that may help preserve pancreatic β-cell function. Additionally, Tinospora is reported to alleviate diabetic complications such as neuropathy, nephropathy, retinopathy, and cardiovascular damage, while also offering protection to vital organs and improving overall quality of life in diabetics. Despite these claims, some research shows that guduchi is not up to mark but has a mild hypoglycemic action.

Hepatoprotective Effects

Guduchi Satwa, an Ayurvedic formulation prepared from different species of Tinospora (including T. cordifolia, T. sinensis, and Neem-Guduchi), demonstrates hepatoprotective potential against alcohol-induced liver toxicity. The study shows that each form of Satwa provides distinct protective effects on liver function, lipid profile normalization, and oxidative stress markers. The results support the potential use of a combined formulation of these Satwas as an effective liver tonic, though clinical trials in humans are needed to confirm efficacy and safety.

Antioxidant and Anti-aging Activity

Some studies claim that the Tinospora cordifolia exhibits strong antioxidant activity and provides protective effects against oxidative stress and liver damage caused by N-nitrosodiethylamine (DEN)-induced hepatocellular carcinoma in rats. It was claimed that Tinospora significantly reduced lipid peroxidation (LPO) levels and restored both enzymatic antioxidants (such as SOD, CAT, and GPx) and nonenzymatic antioxidants (including GSH, Vitamin C, and Vitamin E) to near-normal levels.

Respiratory Infections and COVID-19

Guduchighana Vati, an Ayurvedic formulation made from Tinospora cordifolia (Guduchi), is a safe and potentially effective treatment for asymptomatic and mild-to-moderate cases of COVID-19. In a randomized controlled pilot study, patients receiving Guduchighana Vati showed a higher rate of RT-PCR negativity (93.3%) by day 10, faster clinical recovery, and significant reduction in inflammatory marker IL-6, compared to those receiving standard care with hydroxychloroquine.

Adjunct in Autoimmune Conditions

Some research shows that Tinospora cordifolia exhibits potent anti-arthritic effects in a rat model of rheumatoid arthritis (adjuvant-induced arthritis), primarily by modulating immune responses and preventing joint and bone damage. Tinospora treatment significantly reduced the expression of pro-inflammatory cytokines (IL-1β, IL-6, IL-17, TNF-α), chemokines, and joint-destructive enzymes like MMP-9, while restoring the balance of bone remodeling markers by decreasing RANKL and increasing osteocalcin. Additionally, it lowered the frequency of IL-17/IFN-γ-producing T cells, suggesting a downregulation of Th17-mediated immune responses.

Antiatherosclerotic effect

Some studies claim that the ethyl stem of Tinospora cordifolia exhibits significant anti-atherosclerotic effects in rats fed a high-fat diet, primarily by improving lipid metabolism, reducing inflammation, and protecting cardiovascular tissue. Guduchi led to a marked reduction in total cholesterol, triglycerides, LDL, and VLDL levels, while significantly increasing HDL and total protein levels. It also improved liver enzyme profiles and increased blood clotting time, indicating protective effects against thrombosis.

Available Dosage Form

Capsules and Tablets
Decoctions (Kadha)
Guduchi Satva (dry extract)
Juice or Giloy juice
Topical applications for skin conditions

Safety and Precautions

Generally Recognized as Safe (GRAS)

Guduchi is considered safe for long-term use in appropriate doses.

However, some rare case reports suggest hepatotoxicity with prolonged high-dose use, especially in individuals with pre-existing liver disorders or those taking multiple herbal supplements.

Use with Caution In

Autoimmune diseases (may overstimulate the immune system in some cases)

Pregnant or breastfeeding women (insufficient safety data)

Patients on immunosuppressants or steroids

Conclusion

Guduchi (Tinospora cordifolia) is a multi-functional herb with centuries of traditional use and growing scientific validation. From immune enhancement and metabolic support to liver protection and anti-inflammatory actions, its therapeutic potential is immense. With increasing standardization and preclinical and clinical studies, Guduchi is poised to become a key player in integrative and preventive health strategies.

References

Technical Dossier on Guduchi (Tinospora Cordifolia), Ministry of Ayush, Government of India, https://ayush.gov.in/resources/pdf/quality_standards/guduchi_Book-Dossier.pdf

Alsuhaibani S, Khan MA. Immune-Stimulatory and Therapeutic Activity of Tinospora cordifolia: Double-Edged Sword against Salmonellosis. J Immunol Res. 2017; 2017:1787803. Doi: 10.1155/2017/1787803. Epub 2017 Nov 26. PMID: 29318160; PMCID: PMC5727750.

Sumanlata, Suman A, Sharma RK et.al. Evaluation of anti-inflammatory and antipyretic effect of aqueous extract of tinospora cordifolia in rats. International Journal of Research and Review. 2019; 6(8):340-346.

Ashok BK, Ravishankar B, Prajapati KP, et al, Antipyretic activity of Guduchi Ghrita formulations in albino rats, AYU, Jul-Sep 2010, Vol 31, Issue 3

Rohit S, Vijay K, Ashok BK, et al, Hypoglycemic and anti-hyperglycemic activity of Guduchi Satva in experimental animals. AYU (An International Quarterly Journal of Research in Ayurveda) 34(4):p 417-420, Oct–Dec 2013. | DOI: 10.4103/0974-8520.127726

Sharma R, Amin H, Galib, Prajapati PK, Antidiabetic claims of Tinospora cordifolia (Willd.) Miers: critical appraisal and role in therapy, Asian Pac J Trop Biomed 2015; 5(1): 68-78

Sharma R, Bolleddu R, et al, In-Vitro α-amylase, α-glucosidase Inhibitory Activities and In-Vivo Anti-Hyperglycemic Potential of Different Dosage Forms of Guduchi (Tinospora Cordifolia [Willd.] Miers) Prepared With Ayurvedic Bhavana Process. Front Pharmacol. 2021 May 10;12:642300. Doi: 10.3389/fphar.2021.642300. PMID: 34040519; PMCID: PMC8141809.

Yadav Chandra Kishor, Hegde Prakash L. Hepatoprotective Activity of Patra Swarasa of Guduchi (Tinospora Cordifolia) Against Paracetamol Induced International Journal of Ayurveda and Pharma Research. 2024; 12(6):18-23

.Chavan T, Ghadge A, Karandikar M, et l, Hepatoprotective Activity of Satwa, an Ayurvedic Formulation, Against Alcohol-induced Liver Injury in Rats. Altern Ther Health Med. 2017 Jul; 23(4):34-40. PMID: 28646813.

Chavan T, Khadke S, Harke S, et al, Satwa from three Tinospora species exhibits differential hepatoprotective activity against repeated acetaminophen dosing in rats, Journal of Pharmacy Research, Volume 6, Issue 1, 2013, Pages 123-128, ISSN 0974-6943, https://doi.org/10.1016/j.jopr.2012.11.026

Shukla U, Ujjaliya N, Gupta P, Khare V, et al. Efficacy and safety of Guduchighana Vati in asymptomatic and mild‑to‑moderate cases of coronavirus disease‑19: A randomized controlled pilot study. AYU 2022;41:188-96.

Shukla U, Ujjaliya N, Gupta P, et al, Efficacy and safety of Guduchighana Vati in asymptomatic and mild-to-moderate cases of coronavirus disease-19: A randomized controlled pilot study. Ayu. 2020 Jul-Sep;41(3):188-196. Doi: 10.4103/ayu.ayu_11_21. Epub 2022 Feb 24. PMID: 35370379; PMCID: PMC8966758.

KM Sannegowda, SH Venkatesha, KD Moudgil, Tinospora cordifolia inhibits autoimmune arthritis by regulating key immune mediators of inflammation and bone damage, Int J Immunopathol Pharmacol. 2015 December; 28(4): 521–531. Doi: 10.1177/0394632015608248

How Robotic Technology is Transforming Knee Replacement Surgery

July 1, 2025

by official.ajinkya11@gmail.com with No Comment Disease & Drugs

01 July 2025

Category: Surgical Technology I Robotic Surgery I

Robotic Knee Surgery

Medically Reviewed By: Dr. Dinesh Patil (MBBS, D-Ortho)

Knee and Hip Arthroplasty specialist surgeon

Assisted By: Dewanshee Ingale

Knee replacement surgery has made significant progress in the past few years, offering relief and flexibility to the majority of people who suffer from serious joint pain and arthritis. The integration of robotic technology has made advancements in joint replacement, especially knee surgery, to new heights of precision and efficacy. Robotic-assisted knee replacement surgery has transformed the way orthopaedic surgeries are performed, providing numerous benefits to patients and orthopaedic surgeons.

What is Robotic-Assisted Knee Replacement Surgery

Robot-assisted knee replacement surgery is a new method that uses the most advanced robotic technology and the expertise of an experienced orthopedic surgeon. The robots used in this procedure are either fully automated or semi-automated. It is an extremely refined device that helps the surgeon. The use of robotic technology offers immediate feedback, enhanced visualization, and precise control, which permits the surgeon to position and align the knee implant more precisely than with conventional methodologies.

Surgeons either use a CT scan-driven 3D model of the patient’s knee joint or use an X-ray and their own experience to mark anatomical landmarks. By using either plan, the orthopedic surgeon creates an individualized surgical plan to adapt to the unique anatomy of each patient. The robotic arm simply directs the surgeon’s movements, making sure the bone cuts and implant positioning are implemented with submillimeter accuracy. The systems also allow for enabling adjustments as needed and real-time feedback for optimal results.

With the use of the integration of robotic technology with the experience of excellent orthopedic surgeons, the margin of error, trauma associated with the adjacent tissues are minimized, and it is easy to create a personalized approach for each patient. Resulting in safer, more convenient, and more reliable knee replacement with the ability to recover fast and serve for long-term benefits.

CT Scan-Guided vs Non-CT Scan-Guided Knee Replacement

As advancements in knee replacement surgical techniques evolve, a key distinction has emerged in how these surgeries are planned and executed, like CT scan-guided versus non-CT scan-guided approaches. Each method has its advantages and limitations, and the choice generally depends on the patient’s condition, the surgeon’s expertise, and available resources.

CT scan-guided or image-based knee replacement involves preoperative 3D imaging, usually using a computed tomography (CT) scan. This scan helps generate a patient-specific surgical plan, customized to the individual’s bone anatomy and alignment. In CT scan-guided knee replacement, a detailed scan of the knee is used to create a 3D model of the patient’s knee anatomy. This model helps the surgeon to plan the surgery with high precision by selecting the optimal implant size, position, and alignment. In many cases, custom surgical tools or cutting guides are also 3D-printed based on this data to ensure a perfect fit.

Non-CT scan-guided knee replacement surgery relies on standard X-rays, manual instruments, and the surgeon’s understanding of anatomical landmarks, without the use of preoperative 3D imaging. This traditional approach has been widely used for decades and continues to deliver excellent clinical outcomes in a broad range of patients. It is cost-effective, readily available in most hospitals, and does not expose patients to additional radiation. While it may involve more intraoperative judgment and variability in implant positioning, experienced surgeons can achieve highly successful and durable results using this method.

Fully Automated vs Semi-Automated Knee Replacement Procedures

Depending on the level of technological integration, these procedures can be categorized into fully automated and semi-automated systems, each with its degree of precision, control, and surgeon involvement.

Fully automated systems refer to highly advanced robotic platforms capable of executing surgical tasks with minimal manual intervention. These systems use preoperative imaging (such as CT or MRI scans) to generate a precise 3D model of the patient’s knee, and then autonomously guide or perform steps like bone cutting and implant positioning based on the surgical plan.

Semi-automated procedures are the current standard in robotic-assisted knee replacements. In these surgeries, the robot acts as a guide or assistant, helping the surgeon perform tasks more accurately rather than executing them independently. Semi-automated knee replacement combines real-time navigation with robotic guidance to enhance surgical precision. The surgeon remains in full control, using robotic assistance based on preoperative or intraoperative imaging (CT or imageless systems).

How Does Robotic-Assisted Knee Surgery Work

Preoperative Planning

The process of the knee replacement starts with complete imaging, which involves conducting CT scans or X-rays, which helps the robotic technology to create a detailed and personalized 3D model of the patient’s knee. The obtained 3D model is beneficial for the surgeon to plan a systematic plan for mapping out the precise bone-cutting procedure and implant positioning and its size according to the patient’s distinctive anatomy.

Surgical Guidance

During the surgery, the patient is anesthetized, and to access the knee joint, a small incision is made. The robotic system is then established and synced with the preoperative 3D model. As the surgeon proceeds with the surgery, the robotic arm offers real-time feedback and suggestions to make sure every minute action aligns with the developed surgical plan. The system observes and maintains a proper alignment according to the plan, aids in making accurate bone cuts, and evaluates the soft tissue balance during the procedure.

Enhanced Accuracy

The data-driven approach of the robotic system allows for highly precise placement of the knee implant, enhancing the fitting and the function of the prosthetic joint. The level of precision minimizes the risk of complications, including implant misalignment or asymmetric wear, and results in the easy, quick, and smooth recovery of the patients.

Benefits of Robotic-Assisted Knee Surgery

Proven Precision and Customisation

The robotic-assisted knee replacement uses high-tech imaging and computerized systems to create a 3D image of the knee. And thus patients can plan and implement performing the surgery with submillimeter precision, adapting the position of the implant to the patient’s distinctive anatomy. The research has developed a robotic technology to enhance the correctness of implant orientation, which enhances the long-term results and aids in longer implant life and faster recovery of the patients, and leads to increased patient acceptability.

Reduced Recovery Time

The robotic-assisted knee replacement surgery usually needs minor incisions and leads to reduced trauma to the adjacent tissues. The robotic technology provides a correctness that offers improved soft tissue management. This characteristic of the system helps in better patient tolerability due to the decreased postsurgical ache and discomfort, decreases the blood loss, and also reduces the hospital stay. Hence, it offers patients the chance to start recovery and return to the daily routine a lot faster than a patient who was conventionally operated on.

Increased Patient Satisfaction

Multiple surveys and patient studies were conducted with those undergoing the robotic-assisted knee replacement, which reported increased satisfaction rates. This technology supports improved joint function, reduced aches, and a faster and very easy recovery.

Enhanced Safety and Reduced Complications

The robotic-assisted technology offers up-to-date data and assistance in surgery. Reducing the complications associated with the surgery, such as wrong implant placement or unnecessary bone degradation. The integrated robotic technology lowers the risk of complications and problems associated with surgeries like infection, blood loss, and the need for revision surgery. Consequently, this technology offers overall safety of patient.

Clinical Applications and Case Studies

Malla Reddy Narayana Hospital saw 4-5 successful robotic knee replacement surgeries within weeks of implementing the technology, resulting in less soft tissue damage and early mobilization. On a larger scale, Narayana Health City performed 300 robotic knee replacements over six months, treating patients across 31 Indian districts and 10 other countries.

Challenges and Considerations

Robotic systems are known to show improved results, for which there must be exclusive training in surgeries and maintaining procedural proficiency. Malla Reddy Narayana Hospital has counteracted this via several simulated surgeries and compliance with the international safety protocol. Cost remains a challenge, but institutions are continually making efforts to enhance it through scalable infrastructure.

The Patient Experience

Robotic-assisted knee operation redefines the patient’s journey, allowing smoother and easier recovery comparable to the conventional procedure, hence aiding patients in readily accepting surgery. The surgery is usually done under the effect of anesthesia, which may be general or local, making sure that the patients don’t suffer from pain and feel relaxed throughout the operation.

Hospital stay is the most important factor that makes a patient rethink undergoing surgery, and hence, patients prefer robotic-assisted knee replacement. The most remarkable advantage of this advanced technique is the decreased hospital stay. The majority of people return home in a single day or two post-surgery because of the minor cuts performed during the operation. Same-day discharge is also possible in cases with less complexity and healthy individuals, hence permitting patients to begin recovering at their own homes.

The notable characteristic of robot-assisted surgeries is that patients experience minimal pain and fear because of the minor incisions and correct technique used, which remarkably improves recovery. This methodology supports quick mobilization, with many patients who are able to stand and start walking with support within hours after the surgery.

The patient is started on physiotherapy after the surgery, mostly on the same day or the next morning. Immediate recovery is very important for the restoration of joint movement, fostering strength, and helping with a rapid shift to daily routine. The mixture of reduced postsurgical pain, faster movement, and quick physiotherapy offers a high level of patient satisfaction.

In general, the patient experience is characterized by less pain associated with the joint, fear, and shorter hospital stays, which makes robotic-assisted technology knee replacement a preferred choice in orthopedic patients.

Future Directions

The primary focus of the robotic-assisted knee replacement is fostering customized, efficient, and easily accessible care. One of the significant advancements is the development of custom implant libraries, permitting the surgeons to choose implants as per the unique anatomy of the patient’s knee. Hence, it leads to improved fit and function. The most important development is the combination of predictive analytics with the use of data and artificial intelligence; surgeons are able to predict results and hence personalize recovery plans, leading to faster and more effective recovery. Finally, the ongoing cost reduction measures focus on making the robotic-assisted operations affordable. With the advancing technology and increasing applications, these efforts will continue to make robotic surgery open to a larger number of patients and healthcare organizations. Altogether, these trends are coming together to create a future in which the robotic knee replacement is safer, more accurate, and available to all.

References

Advances in Robotic-Assisted Knee Replacement Surgery https://www.narayanahealth.org/blog/robotic-orthopaedic-surgery

Saber AY, Marappa-Ganeshan R, Mabrouk A. Robotic-Assisted Total Knee Arthroplasty. [Updated 2023 Aug 14]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK564396/

Robotic Knee Replacement Surgery: Types, Procedure, Technology, Benefits, and Risks https://poonahospital.org/blog/robotic-knee-replacement-surgery/

Mobility Matters: Narayan Health City Performs 300 Robotic Knee Replacements in Six Months https://www.healthcareexecutive.in/blog/mobility-matters

Fu X, She Y, Jin G, Liu C, Liu Z, Li W, Jin R. Comparison of robotic-assisted total knee arthroplasty: an updated systematic review and meta-analysis. J Robot Surg. 2024 Jul 25;18(1):292. Doi: 10.1007/s11701-024-02045-y. PMID: 39052153; PMCID: PMC11272701.

Aneja K, Rudraraju RT, Shyam A. Robotic-Assisted Total Knee Arthroplasty: Innovations, Precision, and the Future of Joint Reconstruction. Journal of Orthopaedic Case Reports 2024 December;14(12): 04-07.

Advances in Robotic-Assisted Knee Replacement Surgery https://www.narayanahealth.org/blog/advances-in-robotic-assisted-knee-replacement-surgery

Mancino F, Fontalis A, Kayani B, Magan A, Plastow R, Haddad FS. The current role of CT in total knee arthroplasty. Bone Joint J. 2024 Sep 1;106-B(9):892-897. doi: 10.1302/0301-620X.106B9.BJJ-2023-1303.R1. PMID: 39216858.

Robotic Knee Replacement: Advantages and Disadvantages, Care CHL Hospital, https://www.carehospitals.com/indore/blog-detail/general/robotic-knee-replacement

Wegovy vs. Mounjaro: A Head-On Comparison at the Dawn of Wegovy’s Launch in India

June 30, 2025

by official.ajinkya11@gmail.com with No Comment Disease & Drugs Health Tidings

30 June 2025

Category: Pharmaceutical Market Analysis I Drug Comparison & Reviews I

Obesity Therapeutics

Written by:

Priyanka Khamkar, MPharm, and

Vikas Londhe, MPharm

Reviewed By:

Pharmacally Editorial Team

Wegovy (Semaglutide), the widely acclaimed GLP-1 agonist for weight loss, has officially launched in India by Danish pharmaceutical giant Novo Nordisk, following its overseas success. Wegovy’s launch has set the stage for a direct face-off with Eli Lilly’s Mounjaro (Tirzepatide), which entered the Indian market just three months earlier.

India is now home to the second-largest number of adults living with diabetes; obesity is also on the rise due to interdependent metabolic pathways, poor dietary habits, and increasingly sedentary urban lifestyles. Earlier in India, obesity was considered to be a lifestyle issue, and spending money on anti-obesity drugs was never on the priority list. But as the awareness about obesity and its associated health conditions is increased due to social media, physician counseling, the rise of nutritional health experts, and increased link of obesity with other ailments, it is now being recognized as a chronic, relapsing disease with serious health consequences, including cardiovascular disease, type-2 diabetes, and certain cancers.

Mounjaro, launched earlier this year in March, has already gained a foothold due to its superior weight loss efficacy (up to 23%) and promising results in both diabetes and obesity treatment. In contrast, Wegovy, which got approval in June 2025, has earned widespread global recognition for its effectiveness in achieving 15–20% weight loss and its cardiovascular benefits.

Wegovy is now available in major Indian cities, offering a new option for patients struggling with obesity and its associated health burdens. Its entry indicated not just another medicine option apart from Mounjaro, but a broader shift in India’s healthcare arena, where obesity is finally being addressed with serious medical intervention.

Drug Profiles & Mechanisms

Wegovy (semaglutide)

Type: Once-weekly GLP-1 receptor agonist
Mechanism of Action: Mimics glucagon-like peptide-1 (GLP-1), a natural satiety hormone. It reduces appetite, slows gastric emptying, and enhances insulin secretion, leading to reduced calorie intake and improved metabolic control.
Approved Indications: Approved in India as the first obesity-specific medication with a clear indication for chronic weight management
Also approved for cardiovascular risk reduction in overweight/obese individuals with established heart disease (based on the the SELECT trial).
Clinical Trials & Efficacy: STEP trials (Semaglutide Treatment Effect in People with Obesity): Demonstrated average weight loss of 15%, with some patients reaching up to 20% at higher doses.
Indian data indicates that 1 in 3 patients may achieve 20% weight loss with consistent high-dose use.

Mounjaro (Tirzepatide)

Type: Once-weekly dual GIP and GLP-1 receptor agonist
Mechanism of Action: Acts on both glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptors, offering synergistic metabolic effects. It improves insulin sensitivity, reduces appetite, enhances satiety, and facilitates significant fat loss.
Approved Indications: Initially approved in India for type 2 diabetes, now also approved for chronic weight management. In June 2025, India approved the Mounjaro KwikPen covering full doses (2.5–15 mg) for easier self-administration.
Clinical Trials & Efficacy: SURMOUNT trials, particularly SURMOUNT-1 and SURMOUNT-5, showed average weight loss of 20–22.5%, outperforming semaglutide in head-to-head comparisons.
Recognized for offering one of the highest weight reductions ever seen in obesity pharmacotherapy.

Launch Timeline

Mounjaro launched in India in March 2025 via vials.
Mounjaro KwikPen launched in June 2025.
Wegovy launched on June 24, 2025

Dosage and Delivery Availability

Features	Wegovy Prefilled Pen	Mounjaro Vial	Mounjaro KwikPen (Approved in June 2025)
Device Type	FlexPen (prefilled, single-use pen)	Vial for manual injection	KwikPen (prefilled, auto-injector)
Dose Range	0.25 mg – 2.4 mg	2.5 mg – 5 mg	2.5 mg – 15 mg
Dosing Frequency	Once Weekly	Once Weekly	Once Weekly

Wegovy is available in 5 different doses ranging from 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg. It is available as a single-use FlexPen covering all step-up doses (0.25 mg to 2.4 mg), administered once a week.

The Mounjaro vial provides limited dose options available in two doses, 2.5 mg and 5 mg, which require manual preparation before injection.

Mounjaro, recently approved as a prefilled auto-injector in June 2025, named Mounjaro KwikPen, expands the dosing range up to 15 mg, enabling more convenient and auto-injector-based delivery, administered once weekly.

Pricing of Wegovy

Dose	Per Dose Pricing	Monthly Pricing
0.25mg	Rs. 4366	Rs. 17345
0.5mg	Rs. 4366	Rs. 17345
1.0mg	Rs. 4366	Rs. 17345
1.7mg	Rs. 6070	Rs. 24280
2.4mg	Rs. 6503	Rs. 26015

Pricing of Mounjaro

Dose	Per-Dose Pricing	Monthly Pricing
2.5 mg	Rs. 3500	Rs. 14000
5.0 mg	Rs. 4375	Rs. 17500

Wegovy (semaglutide) is priced uniformly at ₹4,366 per dose for the initial lower doses (0.25 mg to 1.0 mg), with prices increasing for higher doses: 1.7 mg: ₹6,070 per dose (₹24,280/month); 2.4 mg (maintenance dose): ₹6,503 per dose (₹26,015/month)

Mounjaro (Tirzepatide) is more cost-effective in comparison: 2.5 mg (starter dose): ₹3,500 per dose (₹14,000/month); 5.0 mg (maintenance dose): ₹4,375 per dose (₹17,500/month)

Mounjaro offers a significantly more affordable monthly treatment, up to ₹8,500 less per month at maintenance doses, making it a cost-attractive option in India’s growing anti-obesity drug market. However, Wegovy is looking more expensive as compared to Mounjaro, but it is backed by robust global clinical trial data and proven long-term efficacy.

Market Growth and Patient Response

As Mounjaro is having a first-mover advantage, as it is launched in March 2025, it shows explosive growth in its first three months of sales. According to Business Today, data from March to May reveals a steady month-on-month increase in both value and volume sales. Revenue grew from ₹3.46 crore in March to ₹7.87 crore in April and ₹12.60 crore in May, with a cumulative total of ₹23.94 crore over three months. Similarly, unit sales increased from 11,640 units in March to 27,650 in April and further to 42,280 in May, bringing the total to over 81,000 units sold during this period. These figures reflect a strong ascending trend in physician prescribing and patient onboarding since the drug’s market entry in March.

Wegovy, which has now entered the Indian market, is expected to benefit from the same rising demand seen with Mounjaro. Previously, Wegovy faced global supply issues with limited production and distribution due to high demand worldwide. However, those supply problems have now mostly been resolved, specifically for the Indian market, allowing a more stable and consistent availability of the drug in India. This positions Wegovy to compete effectively and meet growing patient needs without the delays or shortages experienced earlier in other countries.

Market Size & Growth

As per the report of HORIZON Grand View Research, India’s anti-obesity medication market is ready for explosive growth. In 2023, the market generated revenue of approximately ₹1,525 crore (USD 183.4 million), and it is projected to reach around ₹21,790 crore (USD 2,619 million) by 2030. This growth represents an impressive compound annual growth rate (CAGR) of 46.2% from 2024 to 2030. The market surge is typically due to rising obesity rates, increasing awareness of related health risks, and a growing demand for effective medical treatments like Mounjaro and Wegovy. As medicine availability and accessibility improve and physician adoption increases, India is emerging as a major market for next-generation weight-loss therapies.

Strategic Battle: Wegovy vs Mounjaro in India

First-Mover Advantage

Eli Lilly gained an early lead by launching Mounjaro in March 2024, capturing physician attention and onboarding patients first. In response, Novo Nordisk quickly launches Wegovy, aiming to exploit the same momentum and not lose market share.

Device Convenience: Pens over Vials

Both companies now use pen devices instead of vials, which are more user-friendly, improve patient adherence, and support easy self-injection.

Efficacy Advantage

In clinical trials, Mounjaro (tirzepatide) showed up to ~23% weight loss, and Wegovy (semaglutide) showed 15–20% weight loss. This superior efficacy profile could tilt the market in favour of Mounjaro, especially for patients seeking maximum weight loss results.

Patent Expiry and Generic Entry

Wegovy (semaglutide) will lose patent protection in India by March 2026, opening the door for low-cost generics, potentially 60–90% cheaper

In contrast, Mounjaro (tirzepatide) remains patent-protected until around 2036, giving Lilly a longer pricing runway and protection from generic competition.

Final Take

India’s anti-obesity drug market is undergoing a crucial shift. Historically, obesity was not recognized as a medical condition in the country, and as a result, anti-obesity medications were often seen as non-essential or lifestyle products. Many patients were unwilling to invest in prescription-based weight loss treatments. However, for the first time, India is witnessing a competitive fight between two global pharmaceutical giants, Eli Lilly and Novo Nordisk, as they strive for dominance in this emerging therapeutic space. This competition signals a shift in perception, where obesity is increasingly considered a serious and treatable health condition, opening the door to more scientifically and medically proven weight management.

Elli Lilly’s Mounjaro currently holds a strategic edge with its superior efficacy (~23% weight loss) and longer patent protection until ~2036, making it well-suited for medically supervised, premium patients who prioritize results and can afford higher prices. Its early market entry and KwikPen device covering the full dose range further strengthen its position.

On the other hand, Novo Nordisk’s Wegovy brings a powerful mix of strong global brand equity and proven cardiovascular benefits, making it highly appealing, especially as obesity increasingly intersects with metabolic and heart health. Novo Nordisk’s accelerated India launch shows a clear intent to capture momentum, particularly in urban centers, before generics flood the market post-2026, when semaglutide’s patent expires.

References

Novo Nordisk launches weight-loss drug Wegovy in India to compete with Lilly’s Mounjaro, Reuters, June 24 2025, https://www.reuters.com/business/healthcare-pharmaceuticals/novo-nordisk-launches-blockuster-weight-loss-drug-wegovy-india-2025-06-24/

Novo Nordisk’s Wegovy debuts in India: How it works, who it’s for, and how much it costs, Times of India, June 27 2025, https://timesofindia.indiatimes.com/life-style/health-fitness/health-news/novo-nordisks-wegovy-debuts-in-india-how-it-works-who-its-for-and-how-much-it-costs/articleshow/122054770.cms

Novo Nordisk launches blockbuster weight-loss drug Wegovy in India; Check price, dosage and other details, The Economics Times, June 24 2025, https://economictimes.indiatimes.com/news/new-updates/novo-nordisk-launches-blockbuster-weight-loss-drug-wegovy-in-india-check-price-dosage-and-other-details/articleshow/122042130.cms?from=mdr

Highlights of prescribing information, Wegovy, https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215256s007lbl.pdf

Highlights of prescribing information, Mounjaro, https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215866s000lbl.pdf

Lilly to launch Mounjaro pen in India to compete with Novo’s weight-loss drug Wegovy, Reuters, June 26 2026, https://www.reuters.com/business/healthcare-pharmaceuticals/lilly-launch-mounjaro-pen-india-compete-with-novos-wegovy-2025-06-26/

Eli Lilly’s Mounjaro hits Rs 24 crore sales in 3 months as adoption grows for diabetes and obesity in India, Business Today, 08 June 2025, https://www.businesstoday.in/industry/pharma/story/eli-lillys-mounjaro-hits-rs-24-crore-sales-in-three-months-as-adoption-grows-for-diabetes-and-obesity-in-india-479483-2025-06-08

Eli Lilly launches weight-loss drug Mounjaro in India, beats Novo Nordisk to major market, March 21 2025, https://www.reuters.com/business/healthcare-pharmaceuticals/eli-lilly-launches-weight-loss-drug-mounjaro-india-after-drug-regulator-approval-2025-03-20/

India Anti-Obesity Medication Market Size & Outlook, HORIZON Grand View Research, https://www.grandviewresearch.com/horizon/outlook/anti-obesity-medication-market/india

Wearable Health Technology: Turning Pharmacovigilance from Reactive to Proactive and Predictive

June 29, 2025

by official.ajinkya11@gmail.com with No Comment Research

29 June 2025

Category: Drug Safety | Health Technology |

Digital Health

Written by:

Utkarsha Patil, M.Pharm

Reviewed and Fact-Checked By:

Vikas Londhe, MPharm

Pharmacovigilance is the phase of clinical trials that continues throughout the lifespan of the medicine. The main aim of pharmacovigilance is to collect clinical trial and post-marketing information related to the safety of medicine. To collect this information, pharmaceutical industries rely heavily on doctors and patients to voluntarily report safety information, which, unfortunately, often results in underreporting and delayed identification of adverse drug reactions (ADRs). Additionally, pharmaceutical industries take proactive steps in the form of different support programs through which they collect safety information, but that requires a lot of effort and increases the economic burden. On the other hand, the major drawback of clinical trials is that they do not provide real-world data, as trials are conducted in a very controlled manner.

In recent times, the popularity of wearable health devices is increasing; for example, smartwatches have almost replaced traditional wristwatches; people love to wear them. These smartwatches track the health data of the person without using any additional devices or any effort. Health data like heart rate, blood pressure, beats, oxygen level, step counts, and daily calories burned etc. have been recorded by Fitbit. These features of health devices are very beneficial in tracking any adverse events in patients, specifically cardiology events.

Hence, the landscape is evolving with the arrival of wearable health technology. Devices like these now facilitate continuous, real-time monitoring of physiological parameters, offering an additional, more proactive, and more comprehensive channel to gather safety information. As per one research published in PLOS Digital Health Journal on wearable devices in digital health, which focused on the main functions of these devices that are monitoring, screening, detection, and prediction, these functions closely resemble the basic principles of pharmacovigilance, i.e., monitoring, detecting, assessing, and understanding adverse events.

Benefits of Wearable Technologies

Wearables are becoming powerful health monitoring tools. As most of the devices work on batteries and are charged and worn throughout the day, they provide comprehensive health data continuously. This ability to continuously collect physiological data could start a new era in pharmacovigilance, where safety information can be observed in real-world settings with accuracy.

Real-Time, Round-the-Clock Monitoring: Wearables operate 24/7, capturing even slight changes in vital signs like irregular heartbeats or sudden blood pressure shifts that might go unnoticed. This allows for quicker identification of potential ADRs compared to traditional reporting methods.

Empowering Patients: These devices give users more control over their health. Patients can easily track their symptoms, receive alerts, and share data with healthcare providers, promoting better communication and medication adherence.

Real-World Evidence (RWE): As mentioned above, unlike controlled clinical trials, wearable data reflects what happens in real life. This helps researchers identify long-term or rare side effects across a broader and more diverse population.

Early Intervention: If a wearable detects warning signs, it can trigger a timely medical review. This allows doctors to adjust dosages, switch medications, or recommend other interventions before issues become serious.

Integration of Wearable Health Technology in Pharmacovigilance

Integration refers to the combination of wearable health devices and artificial intelligence (AI) systems to create a smart, responsive ecosystem that continuously monitors drug safety in real time.

How integration can work step by step

Data Collection from Wearables

Devices such as smartwatches, biosensors, fitness bands, or smart patches collect continuous physiological data, like heart rate changes, sleep cycles, ECG, physical activity, temperature, calorie burn, oxygen levels, glucose, etc.

Real-Time Analysis via AI/ML

These raw data channels are pushed into AI-powered platforms (cloud) that use machine learning algorithms to detect patterns or deviations. This analysis might include filtration of the data, identification of any significant patterns, and generation of actionable insights.

The AI continuously learns from population-level data and individual baselines to distinguish between normal variation and potential adverse drug reactions (ADRs).

Example: If a wearable detects repeated nighttime arrhythmias after a patient starts a new antihypertensive drug, the AI may flag this as a safety signal.

Connection with Digital Therapeutic Apps

Health Device Wearables are typically connected to mobile apps

These apps can:

Notify patients of detected abnormalities
Mobile apps may ask for symptom confirmation (e.g., “Are you experiencing dizziness or palpitations?”)
Prompt them to report side effects
Provide customized health advice or reminders

Automated Reporting & Pharmacovigilance Feedback Loops

If an ADR is suspected, the platform can generate an automated case report for healthcare providers or regulatory bodies.

These systems can be connected to electronic health records (EHRs) or pharmacovigilance databases like the FDA’s FAERS or EMA’s EudraVigilance, improving the speed and accuracy of safety signal detection.

Real-World Applications of Wearable & App Integration in Pharmacovigilance

1. Apple Heart Study—Stanford & Apple (Supported by FDA)

Apple, in collaboration with Stanford University, has conducted a study in approximately 500,000 participants to assess whether the Apple Watch can accurately detect atrial fibrillation (AFib), a potentially serious heart rhythm condition.

The Apple Watch continuously monitors users’ heart rhythms.
Data was sent to a dedicated app.
If an irregular rhythm was detected, users received a notification and were connected to a telemedicine consultation and an ECG patch for clinical confirmation.

This kind of continuous monitoring is now being considered for drug-induced arrhythmias, such as those caused by QT-prolonging medications (e.g., antipsychotics, antibiotics).

2. FDA’s Digital Health Software Precertification Program

Many health startups and companies have developed software that tracks various health-related data of individuals. As a result, this software generally functions similarly to medical devices. To address this, the FDA introduced a program based on the concept of Software as a Medical Device (SaMD). Under this framework, the FDA aims to fast-track the approval of trustworthy software and apps that collect, analyze, and act on health data, including those used for pharmacovigilance purposes.

Under this program, the AI-powered health apps are integrated with wearables (like Fitbit or Garmin) that can detect side effects from drugs (e.g., fatigue, arrhythmia, sleep disruption) to accelerate approval. These systems generate automated alerts to clinicians or researchers.

3. Propeller Health’s Bluetooth-connected Inhaler

Propeller Health (ResMed) focuses on digital respiratory health, particularly for conditions like asthma and COPD. Their system integrates Bluetooth-enabled inhaler sensors with mobile health apps to track medication usage patterns and environmental triggers. By analyzing this real-time data, the platform can detect signs of drug overuse, poor disease control, or adverse effects such as tremors and potential indicators of medication toxicity. This continuous monitoring supports pharmacovigilance efforts by identifying drug misuse, ineffectiveness, and side effects more accurately and contributes valuable safety data to regulatory and clinical databases.

4. Stanford University Studies Using Wearables for Vaccine Safety

During the COVID-19 pandemic, Stanford University partnered with Tel Aviv University to monitor post-vaccine side effects using wearable and mobile apps.

How It Worked:

Participants wore smartwatches and logged symptoms via an app.
Physiological data like resting heart rate, activity level, and sleep were analyzed for changes after vaccination.
Helped detect both expected side effects (like fever) and rare ones.

This study showed how digital tools can enhance post-market surveillance for vaccines and could apply to drug safety monitoring as well.

5. Ongoing Clinical Trials Using Wearables for Drug Safety

Many current FDA-registered trials use wearables for pharmacovigilance-related outcomes:

Trials using continuous glucose monitors (CGMs) to monitor the safety of anti-diabetic drugs.
Smart patches monitor vitals in cancer patients receiving chemotherapy to detect early toxicity.

Special Considerations for Older Adults

Wearable technology has proven useful, especially for seniors. For example, it’s been used to detect medication-related changes in movement or behavior, such as excessive sedation or fall risk, offering insights into how drugs affect older populations in daily life.

Challenges of Wearable health technology

Despite its clear application in the healthcare system, including pharmacovigilance and clinical trials, this technology has some limitations that may hinder its true potential to be used in real-life settings; some of them are

1. Data Accuracy and Validation
Privacy and Data Security Concerns
Integration with Clinical and Regulatory Systems

Conclusion
Wearable health technology has laid the groundwork for a smarter and more responsive approach to drug safety. With the ability to collect real-time, significant data directly from users, these tools are turning pharmacovigilance from a reactive and proactive mode to a predictive mode, where users can predict the adverse event in real time. But to truly unlock their full potential, we must address challenges like privacy protection, device integration, and data reliability. If we work on these aspects, wearable-driven surveillance could reshape drug monitoring into something safer, more efficient, and tailored to individual needs.

Reference

Kalisch Ellett LM, Janetzki JL, Lim R, Laba TL, Pratt NL. Innovations in pharmacovigilance studies of medicines in older people. Br J Clin Pharmacol. 2025 Jan; 91(1):66-83. Doi: 10.1111/bcp.16049. Epub 2024 Mar 26. PMID: 38529693; PMCID: PMC11671332.

Jiang N, Mück JE, Yetisen AK. The Regulation of Wearable Medical Devices. Trends Biotechnol. 2020 Feb; 38(2):129-133. doi: 10.1016/j.tibtech.2019.06.004. Epub 2019 Jul 15. PMID: 31320119.

Muniappan S, Jeyaraman M, Yadav S, Applications of Blockchain-Based Technology for Healthcare Devices Post-market Surveillance. Cureus. 2024 Apr 8;16(4):e57881. doi: 10.7759/cureus.57881. PMID: 38725738; PMCID: PMC11079575.

Badnjević A, Pokvić LG, Deumić A, Bećirović LS. Post-market surveillance of medical devices: A review. Technol Health Care. 2022;30(6):1315-1329. Doi: 10.3233/THC-220284. PMID: 35964220.

Canali S, Schiaffonati V, Aliverti A (2022) Challenges and recommendations for wearable devices in digital health: Data quality, interoperability, health equity, fairness. PLOS Digit Health 1(10): e0000104. https://doi.org/10.1371/ journal.pdig.0000104

Wearable Technology in Healthcare: Types, Benefits, and Future of Medical Devices, topflight, https://topflightapps.com/ideas/wearable-technology-in-healthcare/

Kang HS, Exworthy M. Wearing the Future—Wearables to Empower Users to Take Greater Responsibility for Their Health and Care: Scoping Review. JMIR Mhealth Uhealth. 2022 Jul 13;10(7):e35684. doi: 10.2196/35684. PMID: 35830222; PMCID: PMC9330198.

Real-time Analytics and Interoperability in Wearable Health Technology: Revolutionizing Patient Care, ACL digital, https://www.acldigital.com/blogs/real-time-analytics-and-interoperability-wearable-health-technology-revolutionizing-patient

Perez MV, Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation, The New England Journal of Medicine, N Engl J Med 2019;381:1909-1917 DOI: 10.1056/NEJMoa1901183

Apple Heart Study, Stanford Medicine, https://med.stanford.edu/appleheartstudy.html

Stanford Medicine announces results of unprecedented Apple Heart Study, https://www.apple.com/newsroom/2019/03/stanford-medicine-announces-results-of-unprecedented-apple-heart-study/

The Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings, Sep 2022, US FDA, https://www.fda.gov/media/161815/download

Asthma patients breathe easier with new Bluetooth inhalers, https://www.pbs.org/newshour/health/asthma-patients-breathe-easier-new-bluetooth-inhalers

Chan AHY, Pleasants et al, Digital Inhalers for Asthma or Chronic Obstructive Pulmonary Disease: A Scientific Perspective. Pulm Ther. 2021 Dec;7(2):345-376. DOI: 10.1007/s41030-021-00167-4. Epub 2021 Aug 11. PMID: 34379316; PMCID: PMC8589868.

Guan G, Mofaz M, Qian G, Patalon T, Shmueli E, Yamin D, Brandeau ML. Higher sensitivity monitoring of reactions to COVID-19 vaccination using smartwatches. NPJ Digit Med. 2022 Sep 9;5(1):140. doi: 10.1038/s41746-022-00683-w. PMID: 36085312; PMCID: PMC9461410.

“Gilead’s Yeztugo (Lenacapavir) Receives FDA Nod as First Twice-Yearly Injectable for HIV PrEP”

June 27, 2025

by official.ajinkya11@gmail.com with No Comment New Drug Approval

27 June 2025

Category: New Drug Approval I Sexual Health I

HIV & Infectious Diseases

Written By: Dewanshee Ingale BPharm

Reviewed By: Pharmacally Editorial Team

In the landmark development, FDA has approved Yeztugo (lenacapavir), an antiretroviral drug representing a novel class of antiretroviral drug called capsid inhibitors, invented by the Gilead Sciences, which is approved as a first, and only biannual injection for pre-exposure prophylaxis (PrEP) to protect the human body from sexually acquired HIV in adults and adolescents especially those who are weighing 35 kg and more. The sanction is considered a historic innovation in HIV prevention, presenting a highly efficient and suitable option that addresses the adherence problems, treatment burden, and disease stigma. Authorities believe that Yeztugo has the potential to significantly enhance pre-exposure prophylaxis (PrEP) initiation and adherence, especially in populations facing difficulties with existing treatments. The invention of Yeztugo (lenacapavir) is a breakthrough to end the HIV epidemic.

About Yeztugo

Yeztugo (lenacapavir) is a completely new class of drug that prevents the HIV-1 infection. Yeztugo is developed by Gilead Sciences and is approved by the FDA as the only injectable that can be administered individually twice a year, with a 6-month interval, for pre-exposure prophylaxis (PrEP). This injection is thought to reduce the risk of acquiring HIV in adults and adolescents who weigh 35 kg or more. This subcutaneous injection should be administered by a healthcare professional. The injectable formulation exhibits a pharmacological activity lasting up to six months, which effectively overcomes the limitations associated with daily oral PrEP regimens, including issues of adherence and pill burden.

FDA approval was supported by evidence from the Phase 3 PURPOSE 1 and PURPOSE 2 clinical trials, which confirmed that over 99.9% of participants remained HIV-negative, providing strong validation of the intervention’s efficacy, which makes it superior to the daily oral PrEP medications. Yeztugo is available as a tablet and an injection dosage form, but the indication of PrEP is only indicated for the injection formulation that is administered twice a year. The development of Yeztugo is a breakthrough in HIV prevention. It is said that it will revolutionize HIV treatment and make it much simpler, lowering the stigma and offering patient acceptance.

Background

Before approval of Yeztugo for PrEP, lenacapavir was marketed under the name of Sunlenca, which was utilized for the treatment of multidrug-resistant HIV-1 infection in heavily treatment-experienced adults. Sunlenca provided a vital therapeutic option for patients with limited treatment choices due to the development of resistance to current treatment or any safety and tolerability issues. Sunlenca was administered as a combination regimen along with previous antiretroviral drugs.

The expansion of lenacapavir’s indications from treatment to prevention states a significant breakthrough in the fight against HIV and gives patients hope and practical solutions.

Mechanism: A novel approach

Lenacapavir is a first-in-class, long-acting capsid inhibitor that targets the HIV-1 capsid protein, a highly conserved structural component essential to multiple stages of the viral lifecycle.

Following viral entry into the host cell, the intact HIV-1 capsid must remain stable as it travels through the cytoplasm to the nuclear pore complex, where uncoating and reverse transcription occur. Lenacapavir stabilizes the capsid structure and prevents its disassembly (uncoating), thereby blocking the nuclear material of the viral genome from incorporating with human DNA. This effectively freezes HIV replication at an early post-entry stage.

In case infection had occurred already, in later stages of the viral replication cycle, lenacapavir disrupts proper capsid assembly during the formation of new virions in infected cells. Interfering with capsid multimerization leads to the production of malformed or immature capsids. The resulting virions are structurally defective and non-infectious, impairing viral maturation and spread.

Through these dual-stage inhibitions, blocking nuclear import in the early stage and preventing correct capsid assembly in the late stage, lenacapavir exerts a potent antiviral effect. Its novel mechanism complements other antiretroviral classes and makes it a valuable option for both treatment and pre-exposure prophylaxis (PrEP), particularly in multidrug-resistant HIV-1 infections.

Clinical trials and approval

The approval of Yeztugo comes from the solid foundation of two phase 3 trials: the Purpose-1 and Purpose-2 trials.

The phase 3 Purpose 1 trial (NCT04994509) was a randomized, double-blind study evaluating the efficacy and safety of lenacapavir for HIV-1 pre-exposure prophylaxis (PrEP) in 5,338 cisgender adolescent girls and young women aged 16–25 years across high-incidence regions of South Africa and Uganda. Participants were randomized in a 2:2:1 ratio to receive twice-yearly subcutaneous lenacapavir injections, daily oral emtricitabine–tenofovir alafenamide (FTC/TAF), or daily oral emtricitabine–tenofovir disoproxil fumarate (FTC/TDF). The primary endpoint was the incidence of HIV-1 infection. Zero HIV infections were observed in the lenacapavir group over 2134 participants compared to 39 infections among 2136 participants in the F/TAF group and 16 infections among 1068 participants in the FTC/TDF group, respectively.

The Purpose 2 trial (NCT04925752) was a Phase 3, randomized, double-blind study assessing the efficacy and safety of twice-yearly subcutaneous lenacapavir for HIV-1 pre-exposure prophylaxis (PrEP) in 3,265 individuals, including cisgender men, transgender women, and gender-diverse individuals aged ≥16 years. Conducted across multiple global regions, including North and South America, Europe, Asia, and Africa, the trial randomized participants in a 2:1 ratio to receive either lenacapavir injections every 26 weeks or daily oral FTC/TDF. The primary endpoint was HIV-1 incidence. Lenacapavir demonstrated a significantly lower HIV incidence rate, 2 cases in total compared to FTC/TDF’s 9 cases overall, yielding an 89% relative risk reduction versus oral PrEP and a 96% reduction versus background incidence.

Safety profile

Yeztugo (lenacapavir) has demonstrated a robust safety and tolerability profile across both the pivotal Phase 3 Purpose 1 and Purpose 2 trials. In Purpose 1, the majority of participants experienced at least one adverse event (AE), with most being mild or moderate in severity. The most commonly reported adverse reactions were injection site reactions (ISRs), such as nodules, pain, and swelling. These ISRs were generally mild to moderate, decreased with subsequent injections, and led to discontinuation in only a small fraction of participants (0.2%). No significant or new safety concerns were identified, and serious adverse events were rare. Importantly, there were no serious ISRs or deaths attributed to lenacapavir throughout the trial.

Impact and future viewpoint

FDA approval of Yeztugo (lenacapavir) as the first and only twice-yearly injectable HIV prevention drug is a milestone in the battle against HIV, with ≥99.9% efficacy in phase 3 clinical trials. Yeztugo provides a game-changing solution, breaking through the decades-long HIV prevention barriers, such as adherence barriers, stigma, resistance, and the burden of a daily pill. Its long-acting injectable will be well-suited to increase PrEP adherence and retention.

The approval of Yezugo has been welcomed and appreciated by global health organizations such as the World Health Organization. WHO has prepared new guidelines to help countries integrate lenacapavir into their HIV protection strategies. The biannual dosing system of the drug allows revolutionizing the public health approaches by simplifying prevention, reducing the cases of missing the dose, and potentially curbing new HIV infections in the population.

Looking ahead, the impact of Yeztugo will depend on equitable and rapid access, especially in low- and middle-income countries where the HIV burden is highest. Efforts are underway to accelerate regulatory approvals worldwide and to facilitate generic manufacturing, which could further expand access. Researchers are also exploring the potential for even longer-acting formulations and combination regimens, raising the prospect of once-yearly PrEP and broader protection.

Reference

Yeztugo® (Lenacapavir) Is Now the First and Only FDA-Approved HIV Prevention Option Offering 6 Months of Protection https://www.gilead.com/news/news-details/2025/yeztugo-lenacapavir-is-now-the-first-and-only-fda-approved-hiv-prevention-option-offering-6-months-of-protection

Yeztugo (lenacapavir) FDA Approval History – Drugs.com https://www.drugs.com/history/yeztugo.html

FDA Approves Yeztugo https://www.drugs.com/newdrugs/fda-approves-yeztugo-lenacapavir-first-only-hiv-prevention-option-offering-6-months-protection-6555.html

Twice-Yearly HIV-1 PrEP Yeztugo Gets FDA Approval https://www.infectiousdiseaseadvisor.com/news/twice-yearly-hiv-1-prep-yeztugo-gets-fda-approval/

U.S. FDA Accepts Gilead’s New Drug Applications for Twice-Yearly Lenacapavir for HIV Prevention Under Priority Review https://www.gilead.com/news/news-details/2025/us-fda-accepts-gileads-new-drug-applications-for-twice-yearly-lenacapavir-for-hiv-prevention-under-priority-review

Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection (PURPOSE 1) https://clinicaltrials.gov/study/NCT04994509

Full Efficacy and Safety Results for Gilead Investigational Twice-Yearly Lenacapavir for HIV Prevention Presented at AIDS 2024 https://www.gilead.com/news/news-details/2024/full-efficacy-and-safety-results-for-gilead-investigational-twice-yearly-lenacapavir-for-hiv-prevention-presented-at-aids-2024

Gilead’s Twice-Yearly Lenacapavir Demonstrated 100% Efficacy and Superiority to Daily Truvada® for HIV Prevention https://www.gilead.com/news/news-details/2024/gileads-twice-yearly-lenacapavir-demonstrated-100-efficacy-and-superiority-to-daily-truvada-for-hiv-prevention

Gilead’s twice-yearly shot prevents 100% of HIV cases in trial with women https://www.clinicaltrialsarena.com/news/gileads-twice-yearly-shot-prevents-100-of-hiv-cases-in-trial-with-women/

Long-acting injectable lenacapavir continues to show promising results for HIV prevention https://www.who.int/news/item/26-09-2024-long-acting-injectable-lenacapavir-continues-to-show-promising-results-for-hiv-preventionFDA approval of injectable lenacapavir marks progress for HIV prevention, https://www.who.int/news/item/19-06-2025-fda-approval-of-injectable-lenacapavir-marks-progress-for-hiv-prevention

Bekker LG et al, Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women, N Engl J Med 2024;391:1179-1192, DOI: 10.1056/NEJMoa2407001

Kelley CF et al, Twice-Yearly Lenacapavir for HIV Prevention in Men and Gender-Diverse Persons, N Engl J Med 2025;392:1261-1276, DOI: 10.1056/NEJMoa2411858

Amgen’s Once-Monthly Maridebart cafraglutide (MariTide) Demonstrates Strong Efficacy in Obesity: Positive Phase 2 Maritime 1 Trial Results

June 26, 2025

by official.ajinkya11@gmail.com with No Comment Clinical Trails

26 June 2025

Category: Clinical Trial I Obesity & Metabolic Disorders I

Diabetes and Weight loss

Written and Reviewed By:

Vikas Londhe, MPharm

In recent times, the focus has been shifted to next-generation metabolic therapies and innovative molecules that target the body’s hormonal cascades that are involved in hunger, energy burning, and fat storage. Among them, GLP-1 receptor agonists and GIP-based therapies have improved metabolic health. In this space, Amgen made a bold move into weight loss and diabetes treatments with the development of the maridebart-cafraglutide combination branded as MariTide. Amgen released positive Phase 2 results from their Maritime‑1 trial, and the results are published in the New England Journal of Medicine.

MariTide represents first-in-class dual-action molecules, combining glucagon-like peptide-1 (GLP-1) receptor agonism with glucose-dependent insulinotropic polypeptide (GIP) receptor antagonism potential with a synergistic mechanism that modulates insulin sensitivity and lipid metabolism. MariTide is designed to be administered as a once-monthly subcutaneous dose, which will increase patient compliance and convenience. The trial’s results showing up to 20% body weight reduction position MariTide as a major breakthrough in the near future.

Phase 2 Maritime‑1 Trial

The Phase 2 MARITIME-1 trial was a randomized, double-blind, placebo-controlled, dose-ranging study evaluating maridebart cafraglutide (MariTide) in adults with obesity or overweight who had at least one weight-related comorbidity. A total of 592 participants were enrolled into two cohorts: 465 in the obesity cohort (BMI ≥30 or ≥27 with complications, HbA1c <6.5%) and 127 in the obesity–diabetes cohort (BMI ≥27, HbA1c 7–<10%). Participants received subcutaneous MariTide every 4 or 8 weeks for 52 weeks across varying doses (140, 280, or 420 mg), with or without dose escalation, or placebo. The study assessed weight loss efficacy, metabolic improvements, and safety outcomes.

Endpoints

The primary endpoint was the percentage change in body weight from baseline to week 52. Secondary endpoints included proportions achieving ≥5% to ≥20% weight loss and changes in waist circumference, HbA1c, lipid profiles, CRP, and blood pressure. Safety outcomes focused on gastrointestinal adverse events and treatment discontinuation. The study aimed to evaluate both the weight loss efficacy and broader metabolic benefits of maridebart cafraglutide (MariTide).

Results

In the obesity cohort, maridebart cafraglutide led to a mean body weight reduction of −16.3% to −19.9% (efficacy estimand) compared to 2.6% with placebo. In the obesity–diabetes cohort, reductions ranged from −12.1% to −17.0% compared to 1.4% with placebo. More participants achieved ≥5%, ≥10%, ≥15%, and ≥20% weight loss with maridebart cafraglutide. Additionally, significant HbA1c reduction and improvements in waist circumference, blood pressure, hs-CRP, and lipid profiles were observed.

Side Effects

In the phase 2 trial, 90–99% (obesity) and 91–97% (obesity–diabetes) of participants on maridebart cafraglutide reported at least one adverse event, versus 68% and 81% with placebo, respectively. Gastrointestinal events (nausea, vomiting, retching and diarrhea) were most common and mostly mild to moderate, with higher rates in no-dose-escalation groups. Discontinuation due to GI events occurred in up to 27% of participants. There were 35 serious adverse events and 2 deaths, both deemed unrelated to treatment.

In the phase 2 trial, maridebart cafraglutide was associated with mild-to-moderate hypersensitivity (5%), increased gallbladder events, and a few cases of level 2 hypoglycemia. Minor mood events, slight increases in heart rate, amylase, lipase, and calcitonin (within normal range), and decreased liver aminotransferase levels were noted. No cases of pancreatitis, diabetic retinopathy, or C-cell hyperplasia occurred.

Mechanism of Action

Maridebart cafraglutide works through a unique combination of actions. It blocks the GIP receptor and activates the GLP-1 receptor using two attached GLP-1 agonist peptides (cafraglutide), which together regulate body weight. This combination helps people feel full for longer, slows the emptying of food from the stomach, and reduces hunger, leading to lower calorie intake. It also improves how the body responds to insulin and controls blood sugar levels, making it useful for people with obesity.

Strategic Phase 3 Maritime Design

Amgen’s MARITIME Phase 3 program is currently in progress, consisting of 72-week chronic weight management studies evaluating maridebart cafraglutide (MariTide). The program includes two parallel trials: Maritime 1, enrolling participants with obesity or overweight with at least one weight-related comorbidity, and Maritime 2, targeting individuals with type 2 diabetes. Additional Phase 3 trials evaluating MariTide in patients with atherosclerotic cardiovascular disease, heart failure, and obstructive sleep apnea are expected to launch in 2025. Initial readouts from the ongoing Phase 3 studies are anticipated in 2027, positioning MariTide as a major therapeutic option in obesity and diabetic care.

Bottom Line

Susan Sweeney, executive vice president of Obesity and Related Conditions at Amgen, said, “Obesity affects all parts of the world and people of all different populations, and the challenge is significant.”

We have witnessed a lot of patients in our surroundings, including society, friends, or family; for them, Maridebart Cafraglutide (MariTide) represents a promising new candidate in the competitive market of obesity and metabolic disease treatment. This is backed by robust Phase 2 results showing significant weight loss, metabolic improvements, and a manageable safety profile. MariTide showed the potential to offer meaningful clinical benefits with a once-monthly dosing regimen. At the bottom line, Amgen’s MariTide could redefine long-acting obesity treatment with its potent efficacy, broad metabolic impact, and patient-friendly dosing.

Reference

Jastreboff AM, Ryan DH, Bays HE et al, Once-Monthly Maridebart Cafraglutide for the Treatment of Obesity — A Phase 2 Trial, The New England Journal of Medicine, Published June 23, 2025, DOI: 10.1056/NEJMoa2504214

Results from Amgen’s phase 2 obesity study of monthly Maritide presented at the American diabetes association 85th scientific sessions, Amgen, https://www.amgen.com/newsroom/press-releases/2025/06/results-from-amgens-phase-2-obesity-study-of-monthly-maritide-presented-at-the-american-diabetes-association-85th-scientific-sessions

Inside Amgen’s Phase 3 MARITIME Program: Advancing the Future of Obesity Care, Amgen, https://www.amgen.com/stories/2025/06/inside-amgens-phase-3-maritime-program—advancing-the-future-of-obesity-care

Maridebart Cafraglutide for Chronic Weight Management, iClinique, https://www.icliniq.com/articles/drug-and-supplements/maridebart-cafraglutide#how-does-maridebart-cafraglutide-work-in-obesity-management

Efficacy and Safety of Maridebart Cafraglutide in Adult Participants with Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2), ClinicalTrials.gov ID NCT06858878, https://clinicaltrials.gov/study/NCT06858878

“CagriSema: A Powerful New Weight Loss and Diabetes Combination Therapy Emerges from REDEFINE-2 Trial”

June 24, 2025

by official.ajinkya11@gmail.com with No Comment Clinical Trails

24 June 2025

Category: Clinical Trial I Obesity & Metabolic Disorders I

Diabetes and Weight loss

Medically Written and Reviewed By:

Vikas Londhe MPharm

The race to develop new treatments for obesity and type 2 diabetes is getting more and more competitive. To this race, the results of the REDEFINE 2 trial (NCT05394519), published recently in The New England Journal of Medicine (NEJM). The study highlights the powerful potential of a novel combination therapy, CagriSema. This once-weekly subcutaneous treatment, combining cagrilintide (an amylin analogue) and semaglutide (a GLP‑1 receptor agonist), has shown impressive results for weight loss and glycemic control, especially in individuals with both obesity and type 2 diabetes.

Study at a Glance

The REDEFINE 2 trial (Trial No. NCT05394519) is a Phase 3a, multicenter, randomized, double-blind, placebo-controlled study sponsored by Novo Nordisk, conducted across 12 countries in Europe, North America, and Asia. The study was designed to evaluate the efficacy and safety of CagriSema. CagriSema was administered once weekly in dose dose-escalated manner starting from a 0.25 mg dose and increasing stepwise till it reached 2.4 mg for each drug in 16 weeks. The trial enrolled non-insulin-dependent participants aged 18 years or older with a body mass index of 27 kg/m² or more, HbA1c between 7% and 10%, and at least one self-reported unsuccessful dietary effort to lose weight. The lifestyle modifications were also suggested to study participants. Participants were randomly assigned to receive CagriSema (cagrilintide 2.4 mg + semaglutide 2.4 mg) or placebo over a 68-week treatment period, followed by a 7-week follow-up. The primary endpoint was percentage change in body weight and percentage of patients achieving ≥5% weight loss from baseline to week 68; however, additional secondary endpoints included changes in waist circumference, glycated hemoglobin level, systolic blood pressure, and other physical function measures from baseline to 68 weeks. Results from this trial, published in The New England Journal of Medicine, have shown the potential of CagriSema to offer a new standard of care in obesity and diabetes management.

Key Findings

The REDEFINE 2 trial showed that CagriSema led to significantly greater weight loss and better blood sugar control compared to placebo in people with obesity and Type 2 diabetes. After 68 weeks of treatment, patients receiving CagriSema lost an average of 15.7% of their body weight, which was much higher than the placebo group’s 3.1%. In addition, almost 83.6% of patients in the CagriSema group achieved at least 5% weight loss, a clinically significant benchmark, compared to 30.8% in the placebo group. Additionally, a weight reduction of 10% or more occurred in 65.6% of the patients in the cagrilintide–semaglutide group and in 10.3% of in the placebo group; a weight reduction of 15% or more occurred in 43.8% and 2.4%, respectively, and a weight reduction of 20% or more occurred in 22.9% and 0.5%, respectively. CagriSema also showed greater improvement in blood sugar control, reducing average HbA1c levels by 1.8 percentage points, while the placebo reduced them by only 0.4 percentage only.

On average, systolic pressure went down by 4.1 mm Hg more than the placebo group, a statistically significant difference. Additionally, the combination treatment also showed improvements in diastolic blood pressure, C-reactive protein (a marker of inflammation), and cholesterol levels compared to placebo. On average, waist size reduced by 8.3 cm more than the placebo group.

These results confirmed that the combination therapy offers stronger benefits for both weight and glucose management, especially in patients with diabetes.

Mechanism of Action

Cagrilintide is an amylin analogue, which mimics the action of the natural hormone amylin. It helps to reduce appetite, increase feelings of fullness, and slow down the emptying of the stomach, which leads to reduced food intake and promotes weight loss. It binds to amylin receptors in the brain, specifically in the hypothalamus and other brain regions, to promote feelings of fullness and reduce food intake. On the other hand, semaglutide is a GLP-1 receptor agonist, a class of drugs that stimulates insulin release in response to high blood sugar levels, suppresses glucagon (a hormone that raises blood sugar), and also delays gastric emptying. It plays a dual role in improving glycemic control and enhancing satiety, contributing further to weight reduction. Together, cagrilintide and semaglutide produce synergistic effects.

Safety Profile

CagriSema was generally well tolerated, with a safety profile consistent with what is typically seen with GLP‑1 receptor agonists like semaglutide. The most common side effects reported were gastrointestinal symptoms, including nausea, vomiting, diarrhea, and constipation. These side effects were mostly mild to moderate in severity. A slightly higher number of participants in the CagriSema group discontinued treatment due to side effects compared to the semaglutide and placebo groups. Importantly, no new safety concerns emerged during the trial.

Future Plan

Following the strong results from REDEFINE 2, Novo Nordisk is expected to seek regulatory approval for CagriSema in 2026, supported by earlier data from the REDEFINE 1 trial, which showed an even greater weight loss of 22.7% in people without diabetes. The company is also developing a pre-filled pen for convenient once-weekly dosing, aiming to simplify treatment and enhance patient adherence.

Conclusion and Pharmacally’s Take

CagriSema may emerge as a landmark treatment after approval for diabetes management and obesity care. It combines the benefits of two powerful drugs from their class, offering patients a more effective and synergistic approach to weight and glucose control. This trial proves that individuals with type 2 diabetes, who typically lose less weight than those without, can achieve meaningful and substantial weight loss.

With semaglutide already a blockbuster and tirzepatide on the rise, CagriSema could be the next market capturer in metabolic health and weight loss, especially for patients with complex comorbidities.

References

Davies MJ, Bajaj HS, Broholm C, et al, Cagrilintide–Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes, The New England Journal of Medicine, Published June 22, 2025, DOI: 10.1056/NEJMoa2502082

A Research Study to See How Well CagriSema Helps People with Type 2 Diabetes and Excess Body Weight Lose Weight (REDEFINE 2), ClinicalTrials.gov ID NCT05394519, https://clinicaltrials.gov/study/NCT05394519

Garvey WT, Blüher M, Contreras CKO, et al, Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity, The New England Journal of Medicine, Published June 22, 2025, DOI: 10.1056/NEJMoa2502081

FDA Issues Safety Warning: Transderm Scop (Scopolamine Transdermal System) Antinausea Patch May Cause Heat-Related Illness, Hospitalization, or Death

June 23, 2025

by official.ajinkya11@gmail.com with No Comment Disease & Drugs

June 22, 2025
Category: Drug Safety Alerts | FDA Updates | Patient Safety

Written by: Priyanka Khamkar, MPharm

Reviewed By: Pharmacally Editorial Team

The U.S. Food and Drug Administration (FDA) has issued a serious safety communication regarding Transderm Scōp®, a widely used transdermal patch containing scopolamine marketed by Baxter Healthcare Corporation. This transdermal patch is generally prescribed to prevent motion sickness and postoperative nausea. On June 18, 2025, the FDA issued a warning letter that stated that the patch can impair the body’s ability to regulate temperature, potentially causing dangerous heat-related complications, including hospitalization and even death. FDA specifically observed these events in children 17 years and younger and patients who are 60 years and above, who may be sensitive to control body temperature disturbances. The FDA warns Baxter to include this safety information into the label.

What’s the issue?

The scopolamine transdermal patch, typically applied behind the ear, being an anticholinergic drug, inhibits the neurotransmitter acetylcholine, which results in an anticholinergic effect that may suppress the body’s ability to maintain internal pressure and increase the body’s core temperature, and reduce sweating, making it harder to cool down the body. This disrupts thermoregulation and can result in hyperthermia, especially in hot environments or when combined with external heat sources like heated blankets. The FDA observed that the hyperthermia occurs within 72 hours (3 days) after applying the transdermal patch for the first time to the patient; this increases the causal relation between the drug and the event.

The one more thing highlighted by the FDA is that the Transderm Scop patch is only approved for adults, and it is not allowed to be used in children. So it is not an FDA-approved drug for children. However, in some cases, doctors use it as “off-label” in children, like for excessive drooling with cerebral palsy or other neurologic disorders.

Real-World Cases

A review of safety data by the FDA received worldwide since August 2024 revealed that 13 cases of hyperthermia were directly linked to the scopolamine patch use. The onset of reaction, mostly within 72 hours after patch application, confirmed the causal relationship between the scopolamine patch and hyperthermia. Out of these 13 cases, 8 cases involved children equal to or less than 17 years of age, and 4 cases involved older adults (≥60 years). 6 patients were hospitalized; however, 2 deaths were reported in one pediatric and one geriatric patient. In several cases, body temperatures increase above 105°F (40.5°C).

Understanding the Mechanism

Scopolamine works by blocking acetylcholine, a neurotransmitter involved in many involuntary body functions, including sweating. By reducing sweating, scopolamine can unintentionally cause core body temperature to rise, especially in

Hot weather
Feverish illness
Dehydrated states
Use of heat-generating devices

When the body failed to cool down on its own by the process of sweating, the inner temperature of the body started to increase. The consequences of increased temperature can range from mild confusion and disorientation to loss of consciousness, coma, or even death.

FDA Instructions

After finding these cases, the FDA instructed Baxter Healthcare Corporation to include these safety findings in the label. The label should mention the risk of hyperthermia resulting in serious harm, along with vulnerable population groups of children below 17 years of age and elderly patients above 60 years. The label should instruct patients to remove the patch as soon as their body temperature increases and if they are not experiencing sweating, even if they are in a warm environment.

FDA Guidance: What Patients and Providers Need to Know

The FDA warns patients and caretakers that during use of the Transderm Scop patch, the following instructions should be followed:

Monitor the signs of hyperthermia: flushed skin, lack of sweating, dizziness, confusion, or unusual fatigue.
Avoid heated environments and external heat sources (e.g., heated blankets, direct sun exposure).
If symptoms appear, immediately remove the patch and seek medical attention.
Be aware that side effects can persist for hours or days after patch removal, as the absorbed medicine remains in the body until it’s eliminated.
As the long-term use of the patch or use in children is not allowed, the caretaker or patient should consult with a healthcare professional before starting this therapy.

For Healthcare Professionals

Warn patients and caregivers about the risk of hyperthermia while prescribing, especially in the vulnerable populations of young children and older people. This population is more susceptible to thermoregulatory changes
Instruct patients to remove the patch and consult with a healthcare provider if they experience any hyperthermia symptoms.
The prescriber should make the patient aware of the fact that even if they remove the patch, the symptoms may persist as the medicine remains in the body for hours or days.

Quick Safety Checklist

Do	Don’t
Apply the patch only as directed	Use in children without medical guidance
Monitor the signs of hyperthermia	Exposure to heat sources or wear in high temperatures
Remove the patch if hyperthermia signs occur	Ignore early symptoms like dizziness or fatigue
Inform your doctor about side effects and symptoms	Long-term use of patch

Conclusion & Pharmacally’s Take

At Pharmacally, we encourage patient education and informed usage of medications, especially those with powerful systemic effects like anticholinergics. The FDA warning related to the scopolamine transdermal patch highlights how even commonly prescribed drugs can carry rare but serious risks.

All patients and caretakers should stay vigilant, follow proper application guidelines, and communicate any concerns with healthcare providers immediately. For clinicians, it is important to check the benefit-risk balance of the scopolamine patch in vulnerable populations, and in risky conditions, they should consider safer alternatives if available.

References

FDA adds warning about serious risk of heat-related complications with antinausea patch Transderm Scōp (scopolamine transdermal system), US FDA, 18 June 2025, https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-warning-about-serious-risk-heat-related-complications-antinausea-patch-transderm-scop#:~:text=FDA%20is%20warning%20that%20the,instances%20from%20heat%2Drelated%20complications.

Drug Safety Communication, US FDA, https://www.fda.gov/media/187121/download?attachment

Highlights of prescribing information, Transderm scōp, https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017874s053lbl.pdf

Ms. Priyanka Khamkar is a skilled medical writer at Pharmacally.com with a strong academic foundation, holding an M.Pharmacy in Pharmacology and a GPAT exam qualified. Passionate about research and evidence-based writing, she brings clarity and precision to complex medical topics. Her core interests lie in drug safety, clinical research, and translating science into accessible healthcare content.

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Rising Threat: the Latest Aspergillus fumigatus Outbreak in the U.S. and Global Precautions

June 21, 2025

by official.ajinkya11@gmail.com with No Comment Health Tidings

Published on: 21 June 2025

Category: Health News I Infectious Diseases & Outbreaks I

Fungal Infection

Written By:

Dewanshee Ingale, BPharm

Reviewed and Fact-Checked By:

Pharmacally Medical News Team

Aspergillus fumigatus, a silent but very deadly fungus, is rapidly spreading at a very alarming rate throughout the United States. Aspergillus fumigatus is a prevalent environmental fungus that is gradually being identified as a threat to public health. Initially, this organism was only known to affect the immune systems of immunocompromised patients. But now it has been clear that this fungus is expanding its reach; this fungus is airborne and spreads farther than it did in previous times. Its drug-resistant strain poses a threat to global infectious disease management. Experts in this field warn that not only the USA but also the world is not prepared for the threat that will be caused by the outbreak and spread of this fungus. As the infection rate climbs, especially in areas with warm, humid climates and also in urban, high-density populations, Aspergillus fumigatus poses serious complications to healthcare systems as well as endangers the vulnerable populations across the USA and globally in coming days.

Aspergillus Fumigatus

Aspergillus fumigatus is mold found in the environment at various places like soil, decaying leaves, and compost, and it is also found in indoor environments. The exposure is common to this fungus, and it presents little threat to healthy individuals; however, it can show serious complications in individuals with immunocompromised status or with chronic lung conditions.

The spores of the fungus Aspergillus fumigatus enter the body via the respiratory tract through the air we inhale. The spores reach the nose, throat, sinuses, and lungs. When these spores enter the body of healthy individuals, the immune system usually clears the spores. When these spores enter the bodies of people with compromised immunity or pre-existing lung diseases, the fungus invades the tissues, disrupts immune cell function, forms blood clots, and may also trigger severe allergic reactions.

Major Health Risks and Types of Aspergillosis

The infection with Aspergillus fumigatus can cause a range of conditions collectively known as aspergillosis in people with weakened immune systems or lung conditions. These include:

Allergic Bronchopulmonary Aspergillosis (ABPA): The allergic reaction produced as a reaction to the inhaled spores is most common in individuals with asthma, cystic fibrosis, or bronchiectasis. The symptoms observed are wheezing, coughing, shortness of breath, fever, and, many times, brown or bloody mucus. ABPA may worsen due to the presence of an underlying lung disease and can cause serious asthma attacks.

Chronic pulmonary aspergillosis (CPA) is a progressively growing infection mainly observed in patients with chronic lung diseases like tuberculosis or emphysema. The symptoms reported are persistent cough, severe weight loss, fatigue, breathlessness, and sometimes the occurrence of blood in the cough (hemoptysis), and they may often lead to notable lung damage and scarring if they are not treated.

Aspergilloma (“Fungus Ball”): The fungus forms a tangled mass inside the lung cavity. It often stays asymptomatic but can cause coughing up blood, which may turn severe.

Invasive Aspergillosis the most serious form, seen in the people with seriously weakened immune systems for example cancer, organ transplant, prolonged steroid use etc. the symptoms observed are fever, chest pain, cough (sometimes with blood), shortness of breath, and if the infection still persists may lead to neurological symptoms or often organ dysfunction. This particular form may be life-threatening and may require urgent medications.

Fungal Sinusitis and Other Forms: Spores often infect the sinuses, which cause a stuffy or runny nose, facial pain, headaches, and a decreased sense of smell. In some rare cases, the fungus may also spread through the eyes, skin, brain, or digestive tract, which may lead to the development of additional symptoms like red eyes, blurred vision, skin ulcers, confusion, and abdominal pain.

Who is at risk?

People suffering from cancer, HIV/AIDS, or organ transplants or under the therapy of immunosuppressive drugs have weak immunity, or individuals with chronic lung diseases such as asthma, cystic fibrosis, COPD, or tuberculosis and patients who have recently recovered from serious viral infections like influenza or COVID-19 are at major risk and require mechanical ventilation. Such people are exposed to environments that have a concentration of mold spores, for example, compost heaps, damp buildings, or construction sites.

Details of the U.S. Outbreak

As of mid-2025, multiple states in the U.S., including California, Texas, and New York, have reported a spike in invasive aspergillosis cases caused by azole-resistant Aspergillus fumigatus (ARAf). The Centers for Disease Control and Prevention (CDC) has confirmed that several isolates have genetic mutations associated with environmental fungicide exposure.

Why Is the Outbreak Getting Worse?

Several factors accelerate the spread and the impact of the Aspergillus fumigatus:

Climate Change: Overall, the increasing global warming has caused increased global temperatures and increased humidity that create an environment that is more favorable for the fungus to grow and spread, allowing the fungus to bloom in new areas and increase the risk to life.

Drug Resistance: The overuse of fungicide agents in the agricultural processes leads to the production of strains that are resistant to the first-line antifungal drugs, especially azole antifungals such as voriconazole or itraconazole, which makes the infection more difficult to treat and increases the complications associated with the fungus.

Population Vulnerability: The number of people with compromised immunity is continuously increasing due to the advancements in cancer treatments, organ transplantation, and other chronic disease management.

Environmental Disturbance: The increase in environmental disturbances like construction, renovations, and the occurrence of natural disasters leads to the release of large amounts of spores in the air, which further leads to a significant increase in the risk of outbreaks, especially in the healthcare systems.

USA’s Preparedness and Response

The United States faces significant challenges in tracking and fighting Aspergillus fumigatus-affected patients,, which makes it more difficult to control the outbursts and protect the susceptible populations

The CDC Mycotic Diseases Branch is actively monitoring for azole-resistant Aspergillus fumigatus (ARAf) and promoting molecular testing to detect resistance mutations like TR34/L98H and TR46/Y121F/T289A.

The CDC has promoted antifungal stewardship in healthcare settings to prevent unnecessary use of azole antifungals, parallel to antibiotic stewardship efforts.

Advisory alerts were issued to hospitals and clinicians in affected states (e.g., California, Texas, and New York) recommending

Heightened awareness in transplant units and ICUs
Use of molecular diagnostics for suspected resistant strains
Review of fungicide usage data in surrounding agricultural areas

Recognizing that drug-resistant Aspergillus has environmental origins, U.S. agencies are advancing a One Health approach through the Environmental Protection Agency, which works on regulating fungicide use in agriculture to reduce environmental resistance pressures.

Global concerns

Fungal spores can travel long distances in the air. What starts as a localized outbreak can quickly become a global bio-risk; hence, the threat associated with Aspergillus fumigatus is not only confined to the USA but is also susceptible to global spread by expanding its range, exposing millions more people in Europe, Asia, and the Americas.

The rising number of people undergoing chemotherapy, organ transplants, or long-term corticosteroid therapy makes the global population increasingly vulnerable for infection.

How to Stay Safe from Aspergillus Fumigatus

These are the steps that one must ensure to reduce the risk of this fungus, especially if you are immunocompromised:

Avoid visiting dusty and moldy areas: Staying away from construction sites, renovation zones, compost piles, and places with visible mold would help prevent the spread of infection.

Use Protective Gear: Use protective gear like an N95 mask and gloves whenever you visit such places that pose risks.

Keep Indoor Air Clean: Using HEPA filters at home and inside the hospital rooms to reduce the entry of airborne spores.

Practice Good Hygiene: Wash your hands more often and at regular intervals, especially when you are outdoors, and also make sure to clean the cuts and wounds, if any.

Monitor Your Health: If you have weak immunity and you feel symptoms like a persistent cough, fever, or shortness of breath, immediately see a doctor and seek medical therapy.

Consult Your Doctor: People who are at high risk should communicate with their physicians about the extra preventive measures to be taken to stay safe from the fungal infection, including the antifungal therapies.

By staying informed and following these precautions, you can help protect yourself and your loved ones from this emerging fungal threat.

Conclusion

Aspergillus fumigatus is a blooming public health threat in the US and all around the globe. The rapid spread of this fungus, the increasing resistance to drugs, and the susceptibility of the increasing populations demand immediate consideration from the health organizations, various researchers, and policymakers. The use of protective measures is very crucial to minimize its impact and safeguard public health in the upcoming future.

Reference

Global pandemic warning: Aspergillus deadly fungus mirrors HBO’s ‘The Last of Us’, Times of India, https://timesofindia.indiatimes.com/life-style/health-fitness/health-news/global-pandemic-warning-aspergillus-deadly-fungus-mirrors-hbos-the-last-of-us/articleshow/121438926.cms

Deadly fungus in US threatens lives as infection rates rise in these seven states, Hindustan Times, https://www.hindustantimes.com/world-news/deadly-aspergillus-fumigatus-in-us-threatens-lives-as-infection-rates-rise-in-these-seven-states-101750078523990.html

Aspergillus: All about the fungus that could spark a pandemic like in HBO’s ‘The Last of Us’, Economic Times, https://economictimes.com/news/international/global-trends/aspergillus-all-about-the-fungus-that-could-spark-a-pandemic-like-in-hbos-the-last-of-us/articleshow/121380695.cms

Hiel SJP, Hendriks ACA, Eijkenboom JJA, et al, Aspergillus Outbreak in an Intensive Care Unit: Source Analysis with Whole Genome Sequencing and Short Tandem Repeats. J Fungi (Basel). 2024 Jan 6; 10(1):51. doi: 10.3390/jof10010051. PMID: 38248960; PMCID: PMC10817286.

Data and Statistics on Aspergillosis, US centre for disease control and prevention, https://www.cdc.gov/aspergillosis/statistics/index.html

Risk Factors and Environmental Preventive Actions for Aspergillosis in Patients with Haematological Malignancies https://pmc.ncbi.nlm.nih.gov/articles/PMC10888107/

Arastehfar A, Carvalho A, Houbraken J,et al, Aspergillus fumigatus and aspergillosis: From basics to clinics. Stud Mycol. 2021 May 10;100:100115. Doi: 10.1016/j.simyco.2021.100115. PMID: 34035866; PMCID: PMC8131930.

Rising temperatures could spread deadly fungus, experts warn, and other health stories Global Heat Health Information Network, https://ghhin.org/news/rising-temperatures-could-spread-deadly-fungus-experts-warn-and-other-health-stories/

Aspergillosis Symptoms and Diagnosis, American Lung Association http://lung.org/lung-health-diseases/lung-disease-lookup/aspergillosis/symptoms-diagnosis

Céline M. O’Gorman, Airborne Aspergillus fumigatus conidia: a risk factor for aspergillosis, Fungal Biology Reviews, Volume 25, Issue 3, 2011, Pages 151-157, https://doi.org/10.1016/j.fbr.2011.07.002.

Reducing Risk for Aspergillosis, US centre for disease control and prevention, https://www.cdc.gov/aspergillosis/prevention/index.html

Preventing Aspergillus Fumigatus: Your Guide to a Fungus-Free Environment, Ion Bar, https://auraionbar.com/preventing-aspergillus-fumigatus/

Fungal Disease Laboratories, US centre for disease control and prevention, https://www.cdc.gov/fungal/hcp/laboratories/index.html

Core Elements of Antibiotic Stewardship, US centre for disease control and prevention, https://www.cdc.gov/antibiotic-use/hcp/core-elements/index.html

EPA Finalizes Framework for Interagency Collaboration on Resistance Risks Associated with Antibacterial and Antifungal Pesticides, US Enviornment Protection Agency, https://www.epa.gov/pesticides/epa-finalizes-framework-interagency-collaboration-resistance-risks-associated

Ms. Dewanshee Ingale is a pharmacy graduate with a deep passion for medical writing and evidence-based healthcare communication. She brings a sharp scientific perspective to her work, enriched by certifications in WHO’s Research Ethics Online Learning and Artificial Intelligence in Research and Science. At Pharmacally, she combines her academic foundation and research-driven insights to translate complex medical topics into accessible and reliable health information.

All posts by : official.ajinkya11@gmail.com

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