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WHO 2025 Guidelines: Strategies to Prevent Adolescent Pregnancy in Low and Middle- Income Countries (LMICs)

by with No Comment Health Tidings

Medically Reviewed By Dr. Seema Satbhai BAMS, MPH, PHD (Public Health Expert)

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Introduction

Adolescent pregnancy is still a big health problem around the world, especially in low and middle-income countries. Every year, millions of young girls become mothers, which can harm their health and make it harder for them to finish school or have a better future. To help fix this, the World Health Organization (WHO) has made new guidelines and recommendations to prevent early pregnancies and protect young girls from its adverse effects.

The Scale of the Problem

Every year, about 21 million girls between the ages of 15 and 19 in LMICs countries get pregnant, and about half of these pregnancies are not planned or intentional. In 2021, over 12 million girls aged 15 to 19 and nearly 500,000 girls aged 10 to 14 gave birth. These numbers show that we need to take action, especially in places like sub-Saharan Africa and Latin America, where adolescent pregnancy is most common.

Health and Social Consequences

Adolescent girls who become mothers have a higher chance of facing serious health problems during pregnancy and childbirth. Their babies are also at greater risk of infant mortality. Early pregnancy can also cause big problems in their lives many girls have to leave school, find it harder to get a good job, and may stay poor. Child marriage makes things worse, as young brides often have many pregnancies, feel stressed or sad, and have less control over their own lives.

Underlying Causes of Adolescent Pregnancy

There are many reasons why adolescent pregnancy is common in LMICs’ countries:

Child Marriage: In some cultures, girls are expected to marry before they turn 18, which often lead to early pregnancy.

Lack of Education: Girls who don’t go to school or drop out early are more likely to become pregnant. Education helps them to acquire knowledge of self protection and important skills that can delay marriage and pregnancy.

Poor Access to Health Services: Many adolescents can’t get proper sexual and reproductive information, birth control, or information about their body and their rights.

Gender Inequality: In some places, girls don’t have a community among themselves, which reduces their ability to make informed decisions about sex and contraception.  

Sexual Abuse: Some adolescent pregnancies happen because of forced sex or abuse, which puts girls in even more danger.”

Progress and Remaining Challenges

There has been some good progress in the last 20 years. The number of adolescent births around the world was declined by 34% from 2000 to 2021, and child marriage dropped by 24% between 2010 and 2020. This happened because of better education about sex, community support, and helpful government policies.

But not everyone is seeing these improvements. Girls who live in rural areas, have little education, or come from low-income families are still at risk. Weak health systems and missing policies are still making it hard for many girls to get the help they need.

WHO’s Updated Recommendations

The World Health Organization (WHO) knows there has been progress and many challenges. So, in its new 2025 guideline, WHO suggests two main ways to help

1. Recommendations to Reduce Child Marriage and help married girls

Rec. 1: Teaching girls’ important skills, building their knowledge, assets and build support from society.

Rec 2: WHO recommended the programmes which aims to reduce child marriages and supporting married girls by involving parents and guardians and especially boys and men and subsequently involving broader community to create and sustain gender equitable environment in society.

Rec 3: WHO recommended giving conditional rewards for girls who at the highest risk of child marriage to increase or extend their school attainment and delay marriage as a part of broad strategy under social protection interventions.

Rec 4: WHO recommended removing gender related obstacle and making sure girls can go to school for at least 12 years and get quality education.

Rec 5: WHO recommended that the adolescent girls should be economically empowered by increasing their financial literacy, knowing the importance of savings and access to employment skills that can expand their alternative options to marriage before turning 18.

Rec 6: WHO recommended creating laws and policies that restrict marriages in general before the age of 18. These laws and policies should be uniform with the standards of human rights.

2. Better Access to Birth Control (Contraceptives)
To improve adolescents’ use of contraceptives, WHO suggests:

Rec 1: WHO recommends programs that help adolescents challenge harmful gender norms and build confidence so they can make informed choices about using contraception.

Rec 2: WHO recommends programs that change unfair gender and social rules to help adolescents make their own choices about contraception and to make it easier for them to get and keep using it.

Rec 3: People of reproductive age should have the option to give themselves injectable contraception as another way to access it.

Oral contraceptive pills (OCPs) should be available without a prescription for people who use them.

Emergency contraceptive pills should be available without a prescription for anyone who wants to use them.

Women should be able to get up to a one-year supply of contraceptive pills based on their needs and preferences. Programs should make sure pills are easy to get while also managing supplies well. The system should be flexible so women can get the amount they need when they need it.

Rec 4: WHO recommends taking steps to lower the cost of contraception so that adolescents can afford to start using it and keep using it.

Rec 5: WHO recommends using accurate and safe digital health tools for adolescents as part of sexual and reproductive health programs

Good Practice Statement

Apart from recommendations, WHO has given some good practice statements to prevent child marriages and adolescent pregnancies and better access to contraceptives.

  1. Important leaders like those in politics, government, religion, and local traditions should be encouraged to help stop child marriage and support girls’ rights. These people are even encouraging access to, use of, and continued use of contraception among adolescents.
  2. Efforts to support women and girls should also include the specific needs and rights of girls who are married or living with a partner, whether formally or informally.
  3. Adolescents, including those who are married or living with a partner, should be actively involved in planning, designing, and reviewing programs that support their needs and rights.
  4. Programs to improve the quality of health services should be put in place to help adolescents access, start using, and continue using contraception.
  5. Laws and policies about age, marriage, and consent should be clear and supportive so that adolescents can access sexual and reproductive health services and contraceptives more easily and keep using them.
  6. Adolescents should be actively involved in planning, carrying out, and reviewing programs that support their contraceptive needs and rights.

Global and Local Implementation

The new WHO guidelines highlight that every country and community is different, so plans should be made to fit local needs. WHO is working with other groups like United Nations Population Fund (UNFPA), Girls Not Brides, and Family Planning 2030 to help governments in

Running awareness campaigns

Training local workers and leaders

Giving expert help and advice

Sharing successful ideas and strategies that have worked in other places

Conclusion

Preventing adolescent pregnancy is not only a health priority but also a matter of equity and human rights. Investing in adolescent girls’ education, empowerment, and access to quality health services is essential for building healthier and more resilient community. When girls get a good education, learn about their bodies, and feel confident, they can make better choices for their lives. WHO’s guidelines give countries a clear plan to help every adolescent girl live a healthier, safer, and better life.

References:

WHO releases new guideline to prevent adolescent pregnancies and improve girls’ health, 23 April 2025, World Health Organization

WHO guideline on preventing early pregnancy and poor reproductive outcomes among adolescents in low- and middle-income countries. Geneva: World Health Organization; 2025. Licence: CC BY-NC-SA 3.0 IGO.

Adolescent pregnancy, 10 April 2024, World Health Organization

Emergency contraception, 09 November 2021, World Health Organization

Crooks R, Bedwell C, Lavender T. Adolescent experiences of pregnancy in low-and middle-income countries: a meta-synthesis of qualitative studies. BMC Pregnancy Childbirth. 2022 Sep 12; 22(1):702. Doi: 10.1186/s12884-022-05022-1. PMID: 36096763; PMCID: PMC9469636.

Sabet, Farnaz et al., The forgotten girls: the state of evidence for health interventions for pregnant adolescents and their newborns in low-income and middle-income countries, The Lancet, Volume 402, Issue 10412, 1580 – 1596

Navideh Noori, Joshua L Proctor, Yvette Efevbera, Assaf P Oron – The Effect of Adolescent Pregnancy on Child Mortality in 46 Low- and Middle-Income Countries: BMJ Global Health 2022;7:e007681.

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Google’s TxGEMMA: A Game-Changer for Cost-Effective and Accelerated Drug Development| How It Builds on TxLLM and Powers Agentic-Tx

by with No Comment Disease & DrugsResearch

Written By: Lavanya Chavhan B.Pharm

Reviewed By: Vikas Londhe M.Pharm (Pharmacology)

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Google DeepMind has launched TxGEMMA in the Google’s Health-Check Up event in New York concluded on 18 March 2025. TxGEMMA is a groundbreaking large language model (LLM) designed to transform conventional drug discovery and development. It is built on the success of TxLLM and forms the foundation for its new agent-based platform, AgenticX. TxGEMMA has the potential to significantly reduce the costs and timelines of the research and approval of the latest medicine. 

What Is TxGEMMA?

Therapeutics GEMMA abbreviated as TxGEMMA is a highly specialized language model trained for a strong focus on biomedical data, specifically drug discovery. TxGEMMA is not general LLMs but is tailored to understand the gradation of biological pathways, molecular structures, clinical trial data, and pharmaceutical development processes.

Features of TxGEMMA includes

Fine-tuning for biomedical tasks: TxGEMMA learns from a wide range of high-quality information that is important for discovering new drugs. This includes both publicly available data and private, carefully selected sources. For example, it studies scientific articles from PubMed, which is a large database of medical research papers. It also uses chemical databases that contain information about different molecules and how they behave. In addition, it looks at clinical trial registries, which track the progress and results of medical studies on new treatments, and biomedical patents, which describe new inventions in medicine. By learning from all these trusted sources, TxGEMMA gains a deep understanding of the science behind drug development.

Open-weight accessibility: One of the special things about TxGEMMA is that its creators plan to make its weights (key numbers, the model learns during training) available to the public. These weights are what allow the model to understand and make decisions based on the data it has studied. By sharing them openly, anyone can use, study, and even improve the model. This is different from many other AI models, especially those made by private companies, where the weights are kept secret and only the company can use them. Google’s decision to release TxGEMMA’s weights publically supports and encourages more people from universities, hospitals, and pharmaceutical companies to work together. This can speed up scientific progress and lead to better treatments for patients.

Multi-modal capabilities: In the future, TxGEMMA is expected to become even more advanced by including different types of biological data, not just written or textual information. This means it will be able to work with things like molecular images pictures of molecules at the microscopic level and genomic sequences, which are the complete sets of DNA instructions in living organisms. By combining these various types of data, TxGEMMA will become a multi-modal model, meaning it can understand and learn from many different kinds of biological information at the same time. This will make it much more powerful and effective in discovering new treatments and therapies for diseases.

Conversational AI for Deeper Drug Discovery Insights:

In addition to making predictions, TxGEMMA also comes in special versions designed for conversation called the 9B and 27B chat models. These versions have been instruction-tuned, which means they have been trained to understand and respond to detailed questions and commands, similar to having a knowledgeable research assistant you can talk to. With these chat models; scientists can have in-depth conversations with the AI. For example, they can ask complicated questions about biology or drug development, get clear explanations for why the model thinks a certain molecule might be harmful or helpful, and even carry on an exchange discussion to explore an idea more deeply. This makes the research process more transparent and interactive, helping scientists better understand the model’s reasoning and use its insights more confidently in their work.

TxGEMMA: A Successor of TxLLM

Before TxGEMMA, DeepMind released TxLLM in October 2024, an early experiment focused on translating language modeling capabilities to drug discovery applications. TxLLM proved that LLMs could expressively suggest new molecular targets, predict drug interactions, and assist in clinical trial design. However, TxLLM had some limitations like;

Limited domain-specific optimization

Closed or restricted access for external researchers

Performance bottlenecks when dealing with multi-step drug development workflows

TxGEMMA answered and addressed all these issues with more extensive, focused biomedical training, open weights, and it has ability to be integrated into larger agentic systems like Agentic-Tx.

Agentic-Tx

TxGEMMA is not a standalone model; it is also a part of Agentic-Tx, Google’s new agent-based framework for biomedical research. Agentic-Tx enables multiple AI agents each fine-tuned for specific tasks like target identification, compound optimization, and toxicity prediction, to collaborate intelligently and autonomously.

The Agentic-Tx framework is a smart and powerful system built to improve how scientists do biomedical research, especially when it comes to understanding diseases and finding new treatments. It works like an intelligent assistant that uses large language models (LLMs) advanced AI systems that can understand and generate human-like text. But Agentic-Tx goes even further by combining these language models with up-to-date biomedical knowledge and the ability to think through complex problems step by step. This means it can search for the latest biomedical information, analyze it carefully, and then use that knowledge to suggest treatments that are tailored to a specific patient’s needs. This kind of system has the potential to make drug discovery faster and more accurate.

Agentic-Tx is equipped with 18 tools, including:

TxGemma as a tool for multi-step reasoning

General search tools from PubMed, Wikipedia and the web

Specific molecular tools

Gene and protein tools

Agentic-Tx is positioned to:

Shorter discovery timelines: It helps speed up the early stages of research by automatically generating hypotheses and assisting with preclinical testing, saving valuable time.

Lower costs: By making better predictions early on, TxGEMMA reduces the need for repetitive lab experiments, cutting down on expenses.

Greater innovation: The model can identify new drug targets that traditional methods might overlook, opening the door to breakthrough treatments.

Why TxGEMMA Matters

The process of developing new medicines has become extremely expensive and slow for the pharmaceutical industry. A study in 2020 found that, on average, it costs more than $2.6 billion and takes over 10 years to bring just one drug to the market. This long timeline and high cost make it very difficult to discover new treatments. However, using advanced models like TxGEMMA could help solve some of these challenges. For example, TxGEMMA can help scientists quickly find molecules that are most likely to become effective drugs. It can also make better predictions about whether a compound will be safe and actually work in treating a disease. In addition, it can assist in designing smarter clinical trials that are more likely to succeed, reducing wasted time and resources. Because TxGEMMA’s model weights are openly shared, researchers all around the world from universities to small biotech companies can test, improve, and build on it. This openness could make drug discovery more accessible to everyone, not just large, wealthy pharmaceutical companies.

Conclusion

Google’s TxGEMMA, when used alongside AgenticX and based on the earlier advancements of TxLLM, marks a major turning point in how artificial intelligence can support drug development. This combination of powerful tools represents a paradigm shift a big change in the way things are done in the world of biomedical research. As the challenges of high costs, long timelines, and complex data continue to slow down traditional drug discovery, more scientists are turning to AI for help. Models like TxGEMMA offer a new way forward by making the process faster, more efficient, and more accessible. With continued development and global collaboration, these AI tools could lead to quicker discoveries, more effective treatments, and ultimately, a healthier future for everyone

References:

1. Introducing TxGemma: Open models to improve therapeutics development, Shekoofeh Azizi, 25 March 2025 available from https://developers.googleblog.com/en/introducing-txgemma-open-models-improving-therapeutics-development/

2. Eric Wang, Samuel Schmidgall, Paul F. Jaeger et al, TxGemma: Efficient and Agentic LLMs for Therapeutics, TxGEMMA report available from https://storage.googleapis.com/research-media/txgemma/txgemma-report.pdf

3. Tx-LLM: Supporting therapeutic development with large language models, Eric Wang, 09 October 2024, available from https://research.google/blog/tx-llm-supporting-therapeutic-development-with-large-language-models/

4. TxGemma, Health AI developer foundation, available from https://developers.google.com/health-ai-developer-foundations/txgemma#agentic_orchestration

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Ayurveda and Abhyanga: The Healing Power of Daily Massage

by with No Comment LifestyleWellness

Medically Written and Reviewed by Ayurvedacharya Dr. Gaurav Pathare (BAMS)

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Abhyanga, the application of medicated oils to the body, holds a significant place in Ayurveda as a vital part of the daily regimen. In today’s fast-paced world, where time is often scarce, it’s easy to overlook the importance of self-care. However, Ayurveda teaches us that maintaining health is just as important as managing time. The core principle of Ayurveda, as captured in the saying “Svasthasya Swasthya Rakshanam, Aturasya Vikar Prashamanam,” means “the protection of the health of a healthy person and the alleviation of the ailments of a sick person.” To support this, Ayurveda suggests following a daily regimen (Dinacharya) and seasonal regimen (Ritucharya), with Abhyanga being a major component.

Abhyanga in Ayurveda

Abhyanga is traditionally performed by applying medicated oils to the body, with sesame oil being most commonly used due to its beneficial properties. The oils are often infused with herbs tailored to balance specific doshas (body energies). According to Vagbhatacharya, an ancient Ayurvedic sage, “Abhyangamacharenityam” (abhyanga should be performed regularly), emphasizing its importance in maintaining health. While daily abhyanga may not be feasible in the modern world due to time constraints, it is advised to perform it at least once a week or even once a month for its many benefits.

In contemporary wellness practices, Abhyanga is often referred to as a “Rejuvenation Massage.” This type of massage can be done by oneself, but for maximum benefits, it is best performed by trained therapists and under the guidance of an Ayurvedic physician. A trained practitioner can tailor the oils and techniques to your individual dosha and health conditions. The therapist also knows the correct pressure to apply to specific parts of the body and the duration for which each area should be massaged.

Specific Areas for Abhyanga

Vagbhatacharya specifically highlights the importance of massaging the head, feet, and ears. These areas are particularly sensitive and are prone to Vata dosha imbalances. Vata dosha governs bodily functions like movement, communication, and flexibility, and when it is aggravated, it can lead to dryness and stiffness in the body. To balance this, oils infused with Vata-pacifying herbs are used, giving the oil a thicker consistency to counteract the dryness associated with an aggravated Vata.

Benefits of Abhyanga

Abhyanga provides a wide range of benefits, including

Anti-Aging: Reduces the effects of aging (Jara), promoting youthfulness.

Improved Vision: Enhances eyesight (Drishtiprasadak)

Increased Vitality: Boosts overall body strength (Pushti) and vigor

Relaxation and Sleep: Helps in achieving restful sleep (Swapna) and reduces fatigue (Shrama)

Strengthens the Skin: Makes the skin soft and smooth (Sutvakva)

Balances Vata Dosha: Reduces the effects of excess Vata in the body (Vataha)

Increased Longevity: Supports long life (Longevity benefits)

Vagbhatacharya further emphasizes that regular Abhyanga enhances mental clarity, physical strength, and overall vitality, ensuring better health and well-being.

Who Should Avoid Abhyanga

While Abhyanga is highly beneficial for most people, certain individuals should avoid it

People with Kapha-related diseases: Kapha imbalances result in conditions like obesity, respiratory issues, and excess mucus.

Post-purification individuals: Those who have undergone cleansing treatments like

Vamana (therapeutic vomiting) or Virechana (therapeutic purgation).

People with indigestion: Those suffering from Ajeerna (poor digestion) should refrain from Abhyanga until their digestive health improves.

Post-Abhyanga Care

After performing Abhyanga, it is important to rest for at least 30 minutes to allow the oils to be absorbed and to avoid any exposure to wind or cold. This rest period helps the body fully absorb the medicinal properties of the oils and enhances the overall effectiveness of the treatment.

Conclusion

In today’s stressful and hectic lifestyle, Abhyanga offers a simple yet effective solution to promote health and well-being. Even if daily practice is not always possible, incorporating it into your routine weekly or monthly can lead to significant benefits. Taking the time to care for your body through Abhyanga can lead to better physical and mental health, improved vitality, and a more balanced life.

Reference

Ashtang Hridaya chapter 2 / 7

 

Chlorotonil

A New Hope Against Antibiotic Resistance: Dual Mechanism in Chlorotonils Identified

by with No Comment Disease & DrugsResearch

Written By: Pragati Ekamalli, B.Pharm

Reviewed By: Vikas Londhe M.Pharm (Pharmacology)

Chlorotonil

Introduction

The increase of pathogens that resist multiple drugs is a big danger to global health, making many common antibiotics useless. In an important finding, scientists from Helmholtz Institute for Pharmaceutical Research Saarland (HIPS) have discovered the dual mechanism of action of previously known natural antibiotic called chlorotonils that work against resistant bacteria. This study, published in Cell Chemical Biology, offers new ways to fight infections that do not respond to other antibiotics

Discovery of Chlorotonils

In 2008, a group of researchers from HIPS found something interesting while looking for new antibiotics in soil bacteria. They discovered chlorotonils, the substances taken from a type of soil bacteria called Sorangium cellulosum. Chlorotonils are known for fighting bacteria, especially tough ones like Methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin-Resistant Enterococci (VRE) and the malaria-causing parasite Plasmodium falciparum. They have a special ring shape and contain several chlorine atoms that help them work against bacteria.

However, chlorotonils are hard to dissolve and not very stable, which makes it difficult to turn them into medicines that’s why scientists later synthesized derivatives called dehalogenil to improve its properties, but so far, they have not been used in treatments.

Dual-Action Mechanism: How Chlorotonils Work

Researchers led by Dr. Jennifer Herrmann and Prof. Rolf Müller have found out how chlorotonils work. Unlike most antibiotics, chlorotonils attack bacteria in two ways. First, they attach to the bacteria’s cell wall and cause lipid-targeted membrane depolarization making it weak by causing uncontrolled efflux of potassium ions out of cell. On the other hand chlorotonil functionally inhibit two enzymes a membrane bound phosphatase YbjG and the cytoplasmic methionine amino peptidase MetAP which help the bacteria build their cell wall and proteins.

Dr. Felix Deschner, the main author of the study, explains that when chlorotonils attach to the cell membrane, potassium ions leak out of the cell. This messes up the cell’s internal balance, affecting its functions and pressure. These effects can kill bacterial cells.

By blocking the enzymes phosphatise YbjG and methionine amino peptidase MetAP at the same time; chlorotonils seriously harm the cell’s abilities to produce certain proteins required for cell to live and function, leading to its death.

This two-part approach also explains why chlorotonils work quickly. They quickly disrupt the cell membrane, making it hard for bacteria to resist. Unlike some traditional antibiotics that target specific enzymes where bacteria can adapt by making more enzymes or structurally changing the enzyme, chlorotonils’ varied attack makes it tougher for bacteria to develop resistance.

Overcoming Multidrug Resistance

The new antibiotic Chlorotonil is better than traditional antibiotics because it works in two ways, making it a strong option against antibiotic resistance bacteria.

Regular antibiotics usually focus on single bacterial function like cell wall synthesis. Bacteria can evolve our self through these challenges by doing single mutation in the target pathway.

Chlorotonil, on the other hand, attacks bacteria in two different ways. This means bacteria need to change in two places at the same time to become resistant, which is much less likely to happen. This makes it harder for bacteria to fight back.

However the dual action of Chlorotonil helps each other, making it effective even without combining it with other antibiotics. This makes treatment simpler than using several antibiotics at once.

Implications and Future Research

Researchers at the Helmholtz Centre for Infection Research (HZI) and the Hans Knoll Institute (HKI) are actively advancing the development of chlorotonil-based compounds, particularly focusing on a derivative named dehalogenil. This compound has demonstrated potent activity against both sexual and asexual stages of the malaria parasite Plasmodium falciparum, with no observed resistance under laboratory conditions.

In addition to malaria, chlorotonil derivatives are being investigated for their efficacy against persistent intestinal pathogens like Clostridioides difficile. Studies have shown that chlorotonil A (ChA) can effectively combat dormant stages of C. difficile, which are often resistant to conventional antibiotics, and does so with minimal disruption to the gut microbiome.

The future prospects for researchers at HZI and HKI include advancing dehalogenil through preclinical development, exploring its potential against other resistant pathogens, and collaborating with clinical partners to assess its efficacy in human trials. These efforts are supported by funding from initiatives like GO-Bio initial and the German Center for Infection Research (DZIF), which aim to translate promising compounds into viable therapeutic options.

Conclusion

As antibiotic resistance escalates, innovative solutions like chlorotonils offer hope. Their dual-action mechanism presents a robust strategy against MDR pathogens, reinforcing the importance of natural products in drug discovery. With further research, chlorotonils could become a critical weapon in the fight against superbugs.

References

1. Deschner, Felix et al., Natural products chlorotonils exert a complex antibacterial mechanism and address multiple targets, Cell Chemical Biology, Volume 0, Issue 0, available from https://www.cell.com/action/showPdf?pii=S2451-9456%2825%2900095-9

2. Chlorotonils: Naturals antibiotics’ dual-action mechanism against multidrug-resistant pathogens uncovered, Phys Org, 15 April 2025, available from https://phys.org/news/2025-04-chlorotonils-naturals-antibiotics-dual-action.html

3. W. Hofer, F. Deschner, G. Jézéquel, L. Functionalization of Chlorotonils: Dehalogenil as promising lead compound in vivo application, Angew. Chem. Int. Ed. 2024, 63, e202319765.  https://doi.org/10.1002/anie.202319765

4. Chlorotonil: Game-Changer in the Fight against Multidrug-Resistant Pathogens, Helmholtz Centre for Infection Research, 15 April 2025, available from https://www.helmholtz-hzi.de/en/media-center/newsroom/news-detail/chlorotonil-game-changer-in-the-fight-against-multidrug-resistant-pathogens/

lariocidin

Scientists Discover Lariocidin, a Potent Lasso Shaped Antibiotic in Garden Soil

by with No Comment Disease & DrugsResearch

Written By: Lavanya Chavhan B.Pharm

Reviewed by Vikas Londhe M.Pharm (Pharmacology)

lariocidin

In a remarkable twist of scientific serendipity, researchers have discovered a powerful new antibiotic in an unexpected place a soil sample taken from a technician’s garden. The compound, named lariocidin, belongs to a rare class of antibiotics known as lasso peptides, and has shown promising results in combating drug-resistant bacteria.

A Backyard Breakthrough

Researchers from McMaster University in Ontario, Canada, and the University of Illinois, Chicago, led by Gerry Wright, worked together to discover lariocidin a compound shown to be effective against drug-resistant bacteria.

The discovery came during routine screening of soil samples for potential antimicrobial agents. One particular sample, taken from a home garden, yielded a previously unknown strain of bacteria that produced a unique antimicrobial compound. Upon further study, scientists isolated and characterized lariocidin, a small, intricately folded peptide that adopts a lasso-like structure.

Lasso peptides are named for their distinctive topology — a loop formed by the peptide backbone is threaded by its tail and locked into place, forming a mechanically constrained molecule. This unique structure often contributes to their stability and resistance to degradation, making them particularly appealing as drug candidates.

Lasso Peptide

A lasso peptide is a type of ribosomally synthesized and post-translationally modified peptide (RiPP) that has a unique and highly stable three-dimensional structure, resembling a lasso or slipknot.

Lasso peptides are characterized by A macrolactam ring (a circular peptide structure) at the N-terminus. A tail segment that threads through this ring during synthesis. The tail is “locked” in place by bulky amino acid residues or disulfide bonds, preventing it from slipping back out much like a rope threaded through a loop and pulled tight, hence the name lasso.

This structure is thermodynamically stable and resistant to heat, enzymatic degradation, and extreme pH conditions.

Targeting the Ribosome: A Novel Mechanism

What sets lariocidin apart is its mechanism of action. Unlike many antibiotics that attack bacterial cell walls or DNA replication, lariocidin targets bacterial ribosomes the machinery responsible for protein synthesis. It binds tightly to the ribosome and disrupts translation, halting the production of essential proteins needed for bacterial survival and replication.

Structural studies revealed that lariocidin latches onto a previously underexplored site on the ribosome, a feature that likely contributes to its efficacy against multi-drug resistant strains. This includes pathogens such as Staphylococcus aureus, Enterococcus faecium, and certain strains of Pseudomonas aeruginosa, which have become increasingly difficult to treat with conventional antibiotics.

A Weapon against Superbugs

The rise of antibiotic resistance is a global public health crisis. Each year, antimicrobial-resistant infections claim hundreds of thousands of lives worldwide. The emergence of lariocidin offers a glimmer of hope, especially since it belongs to a relatively untapped class of natural antibiotics with novel mechanisms of action.

Early laboratory studies have demonstrated that lariocidin is not only potent but also exhibits low toxicity to human cells, an essential step toward potential clinical development. Researchers are now working to synthesize analogs of lariocidin, optimize its pharmacokinetics, and assess its efficacy in animal models of infection.

Current status of Lariocidin

In preclinical testing, lariocidin showed strong antibacterial effects without exhibiting toxicity to human cells. In mouse models infected with A. baumannii, the antibiotic significantly lowered bacterial levels and improved survival outcomes.

At present, scientists are working to optimize lariocidin’s potency and are developing scalable production methods to support future clinical use. Although the results so far are encouraging, additional research and clinical trials are essential to confirm its safety and effectiveness in humans.

Nature Still Has Secrets to Reveal

The story of lariocidin is a potent reminder that nature, even in the soil of a backyard garden remains a vast and largely unexplored resource for life-saving compounds. With rising antibiotic resistance threatening global health, the discovery underscores the importance of continued investment in natural product research and microbial biodiversity.

If further studies validate its safety and effectiveness, lariocidin could represent the first in a new class of antibiotics, one that might help turn the tide against resistant bacterial infections.

References

1.Jangra, M., Travin, D.Y., Aleksandrova, E.V. et al.A broad-spectrum lasso peptide antibiotic targeting the bacterial ribosome. Nature(2025). https://doi.org/10.1038/s41586-025-08723-7

2. New lasso-shaped antibiotic kills drug-resistant bacteria, Nature Podcast, Nature, 26 March 2025

3. Julian D. Hegemann, Marcel Zimmermann, Xiulan Xie et al, Lasso Peptides: An Intriguing Class of Bacterial Natural Products, Accounts of Chemical ResearchVol 48, Issue 7 2015

4. Cheng Cheng, Zi-Chun Hua et al, Lasso Peptides: Heterologous Production and Potential Medical Application, Front. Bioeng. Biotechnol. Volume 8 – 2020 https://doi.org/10.3389/fbioe.2020.571165

5. Digging in the dirt: Scientists discover a new antibiotic compound from an old source, University of Minnesota, 31 March 2025

6.Molecule Discovered In Backyard Soil Can Fight Drug Resistant Bacteria, Technology Networks Immunology and Microbiology, 28 March 2025

 

avian influenza

From Poultry to People: The Rising Risk of Avian Influenza (Bird Flu)

by with No Comment Health Tidings

Written By Pragati Ekamalli B.Pharm

Reviewed and Fact Checked by Vikas Londhe M.Pharm (Pharmacology)

avian influenza

Introduction

Bird flu, also known as avian influenza, is a sickness caused by Type A viruses. The first known case of a serious form of bird flu was reported in 1959, and in 1996, a specific strain called H5N1 was found in China. These viruses can infect farm animals like chickens and turkeys and can spread among wild aquatic birds like ducks and geese around the world. Some bird flu viruses can also affect other animals. Normally, humans do not get bird flu, but there have been rare cases where people became infected. This can happen when someone has close contact with sick birds or animals, especially if they touch their face after touching an infected animal or object. The virus can be found in the body fluids of infected animals.

History of avian influenza

In 1878, a vet in northern Italy saw many chickens dying. People didn’t understand viruses well then, so they named the sickness “fowl plague.” At first, it was mixed up with “fowl cholera,” which is caused by bacteria.

By 1901, scientists found out that “fowl plague” were caused by a virus. They figured this out because it could go through a filter, showing it was much smaller than bacteria. Later, technology showed that the virus was a type of H1N1 that affects birds.

In April 1981, at a meeting in First International Symposium on Avian Influenza  at Maryland, researchers decided to stop using the name fowl plague and called it highly pathogenic avian influenza (HPAI) instead.

Types of Avian Influenza

Low Pathogenic Avian Influenza (LPAI):   Low pathogenic avian influenza (LPAI) viruses typically cause mild or no symptoms in poultry and wild birds. However, in poultry, some LPAI strains can mutate into highly pathogenic forms.

Highly pathogenic avian influenza (HPAI): Highly harmful bird flu viruses, especially types A (H5) and A (H7), can make chickens very sick, often killing them within 48 hours. Most bird flu strains are less harmful, but some wild birds and ducks can carry the dangerous virus without showing signs of illness and spread it when they migrate. Some types can also kill wild birds, helping the virus spread around the world and putting both animals and people at risk.


Situation of Avian Influenza in USA

The first big outbreak of bird flu in the U.S. happened in Pennsylvania from 1983 to 1984, caused by the H5N2 strain, leading to the killing of over 17 million birds. In 2002-2003, a less severe H7N2 outbreak in Virginia led to more safety measures. The worst outbreak was in 2014-2015, when H5N2 and H5N8 strains affected the Midwest, resulting in the loss of over 50 million birds, especially in Iowa and Minnesota. Smaller outbreaks happened from 2016 to 2020, mostly affecting small farms and wild birds, highlighting the need for careful monitoring.

Currently, the U.S. is seeing cases of bird flu linked to the H5N1 strain, which has been spreading worldwide since 2021. This virus reached North America that same year, infecting many wild birds and farmed poultry in several states. Since 2022, many wild birds have tested positive for H5N1, and millions of farmed birds have been killed to stop the virus from spreading. Human cases have been rare, but there is still concern about possible transmission to people. A human case was confirmed in 2022 in Colorado involving a poultry worker who had mild symptoms and fully recovered.

In March 2024, H5N1 was found in U.S. dairy cows for the first time. The first infected herds were in Texas and Kansas, with more cases reported in over ten states. The virus was also found in raw milk and nasal swabs, leading to further investigations. This was the first time H5N1 affected large mammals in the U.S. In April 2024, a human case linked to dairy cattle was confirmed in Texas. The person, a dairy worker, had conjunctivitis and fully recovered.

While the overall risk to human health remains low, the continued spread of H5N1 among birds and now mammals represents a serious threat to the agricultural sector. The potential for viral mutations that could make human transmission more efficient is a key concern for health officials.

Current Human Avian Influenza Cases

As of April 2025, there have been several notable developments in human cases of avian influenza (bird flu), particularly involving the H5N1 subtype.

Mexico’s First Human Fatality: A 3-year-old girl from Coahuila, Mexico, tragically died from H5N1 infection, marking the country’s first confirmed human case. Investigations are ongoing to determine the source of infection, with tests on 38 close contacts returning negative results, indicating no immediate human-to-human transmission.

United States Occupational Exposures: In 2024, the U.S. reported 46 human H5N1 cases across six states, primarily among poultry and dairy workers. Most cases were mild, with no critical illnesses or fatalities. Notably, personal protective equipment (PPE) usage among these workers was found to be suboptimal.

Retrospective Worldwide fatality of H5N1

Indonesia: Indonesia has reported the highest number of human fatalities from avian influenza (H5N1) globally, with over 160 deaths since 2003. Most cases resulted from close contact with infected poultry.

Egypt: Egypt has had the highest number of H5N1 cases in the Middle East and Africa, with over 120 confirmed cases and more than 35 fatalities, primarily affecting rural areas with backyard poultry.

Vietnam: Vietnam has experienced 63 deaths from H5N1 since 2003. Despite aggressive control measures, sporadic outbreaks and fatalities have continued due to poultry exposure.

Cambodia: Cambodia has reported over 30 human cases of H5N1, with a high fatality rate, most of the infected individuals died, often due to delayed treatment in rural areas.

China: China has reported fewer human deaths compared to other countries, but still significant, with over 50 fatalities from H5N1 and other avian influenza strains like H7N9, which emerged in 2013.

Cumulative Global Cases: Since 2003, over 950 human H5N1 infections have been reported across 24 countries, with a case fatality rate of approximately 49%.

Public Health Response

Vaccine Development: In response to the growing threat, the U.S. Department of Health and Human Services has allocated $590 million to Moderna for the development of mRNA-based vaccines targeting multiple bird flu subtypes. ​

​Arcturus Therapeutics Holdings Inc. has received FDA clearance to initiate clinical trials for its H5N1 pandemic influenza vaccine candidate, ARCT-2304, also known as LUNAR-H5N1. This self-amplifying mRNA (sa-mRNA) vaccine utilizes Arcturus’ proprietary STARR® platform and LUNAR® delivery technology.

Surveillance Efforts: The Centers for Disease Control and Prevention (CDC) is actively monitoring the situation, utilizing flu surveillance systems to detect H5 bird flu activity in humans and working with states to monitor individuals with animal exposures, subsequently, in April 2025, the FDA granted Fast Track designation to ARCT-2304, aiming to expedite its development and review process.

Conclusion

Bird flu, especially the H5N1 type, has changed from a small problem in birds to a serious worry for both animals and people. More cases are being seen in wild birds, farm animals, and even cows. The virus is showing it can jump from one species to another. While there are not many human cases, the chance that it could change and spread more widely is a big concern. This shows we need to keep a close watch, respond quickly, and speed up vaccine development. As the situation develops, countries need to work together to reduce the risk of a future outbreak and keep people healthy and food supplies safe.

Introduction

Bird flu, also known as avian influenza, is a sickness caused by Type A viruses. The first known case of a serious form of bird flu was reported in 1959, and in 1996, a specific strain called H5N1 was found in China. These viruses can infect farm animals like chickens and turkeys and can spread among wild aquatic birds like ducks and geese around the world. Some bird flu viruses can also affect other animals. Normally, humans do not get bird flu, but there have been rare cases where people became infected. This can happen when someone has close contact with sick birds or animals, especially if they touch their face after touching an infected animal or object. The virus can be found in the body fluids of infected animals.

History of avian influenza

In 1878, a vet in northern Italy saw many chickens dying. People didn’t understand viruses well then, so they named the sickness “fowl plague.” At first, it was mixed up with “fowl cholera,” which is caused by bacteria.

By 1901, scientists found out that “fowl plague” were caused by a virus. They figured this out because it could go through a filter, showing it was much smaller than bacteria. Later, technology showed that the virus was a type of H1N1 that affects birds.

In April 1981, at a meeting in First International Symposium on Avian Influenza  at Maryland, researchers decided to stop using the name fowl plague and called it highly pathogenic avian influenza (HPAI) instead.

Types of Avian Influenza

Low Pathogenic Avian Influenza (LPAI):   Low pathogenic avian influenza (LPAI) viruses typically cause mild or no symptoms in poultry and wild birds. However, in poultry, some LPAI strains can mutate into highly pathogenic forms.

Highly pathogenic avian influenza (HPAI): Highly harmful bird flu viruses, especially types A (H5) and A (H7), can make chickens very sick, often killing them within 48 hours. Most bird flu strains are less harmful, but some wild birds and ducks can carry the dangerous virus without showing signs of illness and spread it when they migrate. Some types can also kill wild birds, helping the virus spread around the world and putting both animals and people at risk.

Situation of Avian Influenza in USA

The first big outbreak of bird flu in the U.S. happened in Pennsylvania from 1983 to 1984, caused by the H5N2 strain, leading to the killing of over 17 million birds. In 2002-2003, a less severe H7N2 outbreak in Virginia led to more safety measures. The worst outbreak was in 2014-2015, when H5N2 and H5N8 strains affected the Midwest, resulting in the loss of over 50 million birds, especially in Iowa and Minnesota. Smaller outbreaks happened from 2016 to 2020, mostly affecting small farms and wild birds, highlighting the need for careful monitoring.

Currently, the U.S. is seeing cases of bird flu linked to the H5N1 strain, which has been spreading worldwide since 2021. This virus reached North America that same year, infecting many wild birds and farmed poultry in several states. Since 2022, many wild birds have tested positive for H5N1, and millions of farmed birds have been killed to stop the virus from spreading. Human cases have been rare, but there is still concern about possible transmission to people. A human case was confirmed in 2022 in Colorado involving a poultry worker who had mild symptoms and fully recovered.

In March 2024, H5N1 was found in U.S. dairy cows for the first time. The first infected herds were in Texas and Kansas, with more cases reported in over ten states. The virus was also found in raw milk and nasal swabs, leading to further investigations. This was the first time H5N1 affected large mammals in the U.S. In April 2024, a human case linked to dairy cattle was confirmed in Texas. The person, a dairy worker, had conjunctivitis and fully recovered.

While the overall risk to human health remains low, the continued spread of H5N1 among birds and now mammals represents a serious threat to the agricultural sector. The potential for viral mutations that could make human transmission more efficient is a key concern for health officials.

Current Human Avian Influenza Cases

As of April 2025, there have been several notable developments in human cases of avian influenza (bird flu), particularly involving the H5N1 subtype.

Mexico’s First Human Fatality: A 3-year-old girl from Coahuila, Mexico, tragically died from H5N1 infection, marking the country’s first confirmed human case. Investigations are ongoing to determine the source of infection, with tests on 38 close contacts returning negative results, indicating no immediate human-to-human transmission.

United States Occupational Exposures: In 2024, the U.S. reported 46 human H5N1 cases across six states, primarily among poultry and dairy workers. Most cases were mild, with no critical illnesses or fatalities. Notably, personal protective equipment (PPE) usage among these workers was found to be suboptimal.

Retrospective Worldwide fatality of H5N1

Indonesia: Indonesia has reported the highest number of human fatalities from avian influenza (H5N1) globally, with over 160 deaths since 2003. Most cases resulted from close contact with infected poultry.

Egypt: Egypt has had the highest number of H5N1 cases in the Middle East and Africa, with over 120 confirmed cases and more than 35 fatalities, primarily affecting rural areas with backyard poultry.

Vietnam: Vietnam has experienced 63 deaths from H5N1 since 2003. Despite aggressive control measures, sporadic outbreaks and fatalities have continued due to poultry exposure.

Cambodia: Cambodia has reported over 30 human cases of H5N1, with a high fatality rate, most of the infected individuals died, often due to delayed treatment in rural areas.

China: China has reported fewer human deaths compared to other countries, but still significant, with over 50 fatalities from H5N1 and other avian influenza strains like H7N9, which emerged in 2013.

Cumulative Global Cases: Since 2003, over 950 human H5N1 infections have been reported across 24 countries, with a case fatality rate of approximately 49%.

Public Health Response

Vaccine Development: In response to the growing threat, the U.S. Department of Health and Human Services has allocated $590 million to Moderna for the development of mRNA-based vaccines targeting multiple bird flu subtypes. ​

​Arcturus Therapeutics Holdings Inc. has received FDA clearance to initiate clinical trials for its H5N1 pandemic influenza vaccine candidate, ARCT-2304, also known as LUNAR-H5N1. This self-amplifying mRNA (sa-mRNA) vaccine utilizes Arcturus’ proprietary STARR® platform and LUNAR® delivery technology.

Surveillance Efforts: The Centers for Disease Control and Prevention (CDC) is actively monitoring the situation, utilizing flu surveillance systems to detect H5 bird flu activity in humans and working with states to monitor individuals with animal exposures, subsequently, in April 2025, the FDA granted Fast Track designation to ARCT-2304, aiming to expedite its development and review process.

Conclusion

Bird flu, especially the H5N1 type, has changed from a small problem in birds to a serious worry for both animals and people. More cases are being seen in wild birds, farm animals, and even cows. The virus is showing it can jump from one species to another. While there are not many human cases, the chance that it could change and spread more widely is a big concern. This shows we need to keep a close watch, respond quickly, and speed up vaccine development. As the situation develops, countries need to work together to reduce the risk of a future outbreak and keep people healthy and food supplies safe.

References

1.Tripathi AK, Sendor AB, Sapra A. Avian Influenza. [Updated 2025 Feb 5]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan. Available from:https://www.ncbi.nlm.nih.gov/books/NBK553072/

2. Avian Influenza, World Organization for Animal Health, available from https://www.woah.org/en/disease/avian-influenza/

3. H5 Bird Flu: Current Situation, US centres for disease control and prevention, 11 April 2025, available from https://www.cdc.gov/bird-flu/situation-summary/index.html

 4. Confirmations of Highly Pathogenic Avian Influenza in Commercial and Backyard Flocks, Animal and Plant Health Inspection Service, U.S. Department Of Agriculture

5. Lycett SJ, Duchatel F, Digard P. A Brief History of Bird Flu. Philos Trans R Soc Lond B Biol Sci. 2019 Jun 24; 374(1775):20180257. Doi: 10.1098/rstb.2018.0257. PMID: 31056053; PMCID: PMC6553608.

 6. 2020-2024 Highlights in the History of Avian Influenza (Bird Flu) Timeline, US centres for disease control and prevention, 30 April 2024, available from https://www.cdc.gov/bird-flu/avian-timeline/2020s.html

7. What Are the Earliest Known Origins of Bird Flu? Available from https://www.history.com/articles/bird-flu-origins-humans-pandemic

8. Past Reported Global Human Cases with Highly Pathogenic Avian Influenza A (H5N1) (HPAI H5N1) by Country, 1997-2025, avian Influenza (Bird Flu), available from https://www.cdc.gov/bird-flu/php/avian-flu-summary/chart-epi-curve-ah5n1.html

9. Avian Influenza Weekly Update # 993: 11 April 2025, World Health Organization, available from https://www.who.int/westernpacific/publications/m/item/avian-influenza-weekly-update—993–11-april-2025

 10. Global Avian Influenza Viruses with Zoonotic Potential situation update, Animal Health, Food and Agriculture organization of United Nations, available from https://www.fao.org/animal-health/situation-updates/global-aiv-with-zoonotic-potential/en

11. Avian Influenza (H5N1) Vaccines: What’s the Status? American Society of Microbiology, 04 March 2025, available from https://asm.org/articles/2025/march/avian-influenza-h5n1-vaccines-what-status

 12. US awards Moderna $590 million for bird flu vaccine development, Reuters, January 18 2025, available from https://www.reuters.com/business/healthcare-pharmaceuticals/us-awards-moderna-590-million-bird-flu-vaccine-development-2025-01-17/

 13. Arcturus Therapeutics Receives U.S. FDA Fast Track Designation for the STARR® mRNA Vaccine Candidate ARCT-2304 for Pandemic Influenza A Virus H5N1, Arcturus Therapeutics, 10 April 2025, available from https://ir.arcturusrx.com/node/13116/pdf

odactra (2)

FDA expand drug label of ALK’s Odactra for the Treatment of House Dust Mite Allergy in Young Children

by with No Comment Disease & DrugsNew Drug Approval

Written By Lavanya Chavhan B.Pharm

Reviewed and Fact Checked by Vikas Londhe, M.Pharm (Pharmacology)

odactra (2)

The U.S. Food and Drug Administration (FDA) has recently expanded label for ALK-Abelló’s Odactra, a sublingual immunotherapy tablet, to treat house dust mite (HDM) allergies in children as young as five years old. This landmark decision expands access to a groundbreaking therapy previously approved for adults, offering a safe and convenient option for young children grappling with this pervasive allergen. 

What is Odactra?

Odactra s the allergen extract of House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus). It is prescription medication designed to address house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis. It is indicated in case of Confirmed positive in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites.  It is approved in the population from 5 years old to 65 years old age patient.

Administered as a once-daily tablet as sublingual that dissolves under the tongue, it works by exposing the immune system to small, controlled amounts of dust mite allergens. Over time, this exposure helps desensitize the body, reducing the severity of allergic reactions. Unlike traditional treatments such as antihistamines or nasal corticosteroids, which only alleviate symptoms, Odactra targets the root cause of allergies, offering potential long-term relief.

Significance of the Approval

House dust mites (HDMs) are microscopic arachnids (related to ticks and spiders) that thrive in warm, humid environments. They feed on dead human skin cells and are commonly found in mattresses, pillows, upholstered furniture, and carpets. The allergens are primarily from their faeces and body fragments. House dust mites are a leading trigger of perennial allergies, affecting millions of children worldwide.

For sensitized individuals, short-term exposure can cause immediate allergic reactions, including Allergic rhinitis, Asthma exacerbations, Allergic conjunctivitis, and Skin irritation. Prolonged exposure and chronic sensitization can lead to Persistent asthma, chronic rhino sinusitis, Atopic dermatitis, increased risk of developing new allergies.

Chronic symptoms like sneezing, nasal congestion, and itchy eyes can disrupt sleep, school performance, and overall quality of life. For young children, whose immune systems are still developing, uncontrolled allergies may also heighten the risk of developing asthma.

Global Prevalence of HDM allergy estimated to affect 65–130 million people globally, in some regions, up to 80% of asthmatic children are sensitized to HDM however in adults’ sensitization rates range from 20% to 30% in general populations.

A renowned pediatric allergist involved in Odactra’s clinical trials, emphasized the importance of this approval: “Immunotherapy at an early age can alter the course of allergic disease. Odactra’s sublingual form is particularly advantageous for children, avoiding the anxiety associated with allergy shots.” 

Clinical Trial Insights

The clinical trial (NCT04145219) performed in children was double-blind, placebo-controlled, randomized field efficacy study conducted in Europe, the United States and Canada for a duration of approximately 12 months comparing the efficacy of ODACTRA (N=693) to placebo (N=706) in the treatment of HDM allergic rhinitis/rhino conjunctivitis with or without asthma in children 5 through 11 years of age.

The FDA’s decision followed this phase III study which evaluated safety and efficacy of odactra in young children. Results demonstrated a significant reduction in allergy symptoms and medication use compared to placebo. Participants also reported improved sleep and daily functioning. The trial highlighted Odactra’s tolerability, with most side effects being mild, such as oral itching or throat irritation. Severe reactions were rare, aligning with the therapy’s established safety profile in adults. 

Safety and Accessibility

During the pediatric clinical trial, the most commonly reported adverse reactions included ear and mouth itching, followed by throat irritation, abdominal pain, altered taste, and lip swelling. However, since its initial approval, Odactra has carried a black box warning for anaphylaxis and is contraindicated in individuals with uncontrolled asthma.

Conclusion

The FDA’s expansion of Odactra’s approval marks a pivotal advancement in managing HDM allergies in children. By offering a convenient, home-based therapy, Odactra empowers families to address allergies proactively, potentially reducing long-term health burdens. Parents of affected children are encouraged to consult allergists to determine if Odactra is a suitable option. 

As research continues to underscore the benefits of early intervention, Odactra stands out as a beacon of innovation in the quest to improve pediatric health outcomes. 

References

  1. Package Insert, Highlights of Prescribing Information, Odactra, ALK-Abelló A/S available from https://www.fda.gov/media/103380/download

2. Odactra, US Food and Drug Administration, 17 March 2025 available from https://www.fda.gov/vaccines-blood-biologics/allergenics/odactra

3. Bracken SJ, Adami AJ, Szczepanek SM, et al, Long-Term Exposure to House Dust Mite Leads to the Suppression of Allergic Airway Disease Despite Persistent Lung Inflammation. Int Arch Allergy Immunol. 2015;166(4):243-58. doi: 10.1159/000381058. Epub 2015 Apr 28. PMID: 25924733; PMCID: PMC4485530.

4. Dust Mites, American Lung Association, 05 Nov 2024, available from https://www.lung.org/clean-air/indoor-air/indoor-air-pollutants/dust-mites

5. Schuster, Antje et al., Efficacy and safety of SQ house dust mite sublingual immunotherapy-tablet (12 SQ-HDM) in children with allergic rhinitis/rhino conjunctivitis with or without asthma (MT-12): a randomised, double-blind, placebo-controlled, phase III trial, The Lancet Regional Health – Europe, Volume 48, 101136

6. Solarz, K., Obuchowicz, A., Asman, M. et al. Abundance of domestic mites in dwellings of children and adolescents with asthma in relation to environmental factors and allergy symptoms. Sci Rep 11, 18453 (2021). https://doi.org/10.1038/s41598-021-97936-7.

Qfitlia_optimized_2000

FDA Approves Qfitlia: First siRNA Therapy for Haemophilia Prophylaxis

by with No Comment Disease & DrugsNew Drug Approval

Written by Aishwarya Shinde (B.Pharm)

Reviewed and Fact Checked by Vikas Londhe M.Pharm (Pharmacology)

Qfitlia_optimized_2000

The U.S. Food and Drug Administration (FDA) has granted approval for Qfitlia (fitusiran), a groundbreaking therapy designed for the routine prophylaxis of bleeding episodes in individuals with haemophilia A or B. This approval, announced on March 28, 2025, marks a significant advancement in the treatment of these rare genetic bleeding disorders. Qfitlia is authorized for use in adults and pediatric patients aged 12 years and older, regardless of the presence of factor VIII or IX inhibitors.

Haemophilia A and B

Haemophilia is a rare, inherited bleeding disorder caused by deficiencies in clotting factors, leading to prolonged bleeding episodes. The two main types are Haemophilia A (deficiency of Factor VIII) and Haemophilia B (deficiency of Factor IX), both inherited as X-linked recessive disorders. Since the defective gene is located on the X chromosome, males (XY) are typically affected, while females (XX) are usually carriers. However, rare cases of female haemophilia can occur due to lyonization, where the healthy X chromosome is inactivated.

Conventional treatments for haemophilia focus on managing bleeding episodes and preventing complications. Replacement therapy includes recombinant or plasma-derived Factor VIII concentrates for Haemophilia A and Factor IX concentrates for Haemophilia B. Prophylactic treatment involves regular infusions to prevent bleeding, particularly in severe cases. Additional therapies include Desmopressin (DDAVP) for mild Haemophilia A, which stimulates Factor VIII release, and antifibrinolytics like tranexamic acid to stabilize clots, especially in mucosal bleeding.

Recent advances in treatment include gene therapy, such as etranacogene dezaparvovec for Haemophilia B, offering potential long-term solutions. Haemophilia A is more prevalent, affecting approximately 1 in 5,000 male births, while Haemophilia B occurs in 1 in 30,000 male births. Globally, an estimated 400,000 people are affected by the disorder. Ongoing research and novel therapies aim to improve quality of life and reduce the burden of this chronic condition.

Need of an Advance Therapy

However the advanced therapies are needed for haemophilia A and B to address the limitations of conventional treatments and improve patient outcomes. While traditional factor replacement therapies are effective, they require frequent intravenous infusions, which can be burdensome for patients and may lead to complications like inhibitor development (antibodies against clotting factors). Additionally, some patients experience breakthrough bleeding despite prophylaxis, highlighting the need for more durable and convenient solutions.

Qfitlia: A Novel Approach to Haemophilia Management

Developed by Sanofi, Qfitlia (Fitusiran) is an RNA interference (RNAi) therapeutic developed for the treatment of haemophilia A and B, as well as other bleeding disorders. It is designed to reduce bleeding episodes by silencing the production of antithrombin (AT), a natural anticoagulant protein, through RNA interference rather than replacing the missing clotting factors (as in conventional therapies).

Fitusiran is a synthetic siRNA molecule encapsulated in a lipid nanoparticle for targeted delivery to hepatocytes (liver cells). Once inside the liver, it binds to the messenger RNA (mRNA) encoding antithrombin (SERPINC1 gene).

The siRNA triggers the degradation of antithrombin mRNA, reducing antithrombin production. Lower antithrombin levels shift the hemostatic balance toward a pro-coagulant state, promoting thrombin generation and improving clot formation.

In haemophilia, deficient Factor VIII (Haemophilia A) or Factor IX (Haemophilia B) leads to impaired thrombin burst, by reducing antithrombin, fitusiran bypasses the need for exogenous clotting factors, allowing even low levels of endogenous Factors VIII/IX to work more effectively.

The therapy is administered via subcutaneous injections as few as six times per year, offering a significant reduction in treatment burden compared to existing options. It is available in a convenient prefilled pen or vial-and-syringe format, making it easier for patients and caregivers to manage.

Clinical Efficacy

The FDA’s approval was based on data from Sanofi’s ATLAS clinical trial program, which included phase 3 studies such as ATLAS-A/B and ATLAS-INH.

ATLAS-A/B study was a Phase 3, multicenter, open-label, randomized trial evaluating the efficacy and safety of fitusiran prophylaxis in males aged 12 years and older with severe haemophilia A or B without inhibitors. The study enrolled 120 participants across 45 sites in 17 countries.Participants were randomized in a 2:1 ratio to receive either once-monthly 80 mg subcutaneous fitusiran prophylaxis or continue with on-demand clotting factor concentrates for duration of 9 months.

Key Findings includes, Annualized Bleeding Rate (ABR): The median ABR was 0.0 (interquartile range [IQR] 0.0–3.4) in the fitusiran group, compared to 21.8 (IQR 8.4-41.0) in the on-demand group. The estimated mean ABR was significantly lower in the fitusiran group (3.1) than in the on-demand group (31.0), representing an approximate 90% reduction. Bleed-Free Participants: Approximately 51% of participants in the fitusiran group experienced no treated bleeds during the study period, compared to 5% in the on-demand group.

ATLAS-INH study, was a Phase 3, open-label, randomized trial evaluating the efficacy and safety of fitusiran in individuals aged 12 years and older with severe haemophilia A or B who have inhibitors to factor VIII or IX. Participants were randomly assigned in a 2:1 ratio to receive once-monthly 80 mg subcutaneous fitusiran prophylaxis or to continue with on-demand treatment using bypassing agents (BPAs).

Fitusiran prophylaxis led to a significant reduction in the annualized bleeding rate (ABR), with a 90.8% decrease compared to the on-demand BPA group. Approximately 66% of participants receiving fitusiran experienced zero treated bleeds during the study period, compared to 5% in the BPA group.

Based on the results from the ATLAS-INH and other related trials, the U.S. Food and Drug Administration (FDA) approved fitusiran, marketed as Qfitlia, for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients aged 12 years and older with haemophilia A or B, with or without inhibitors.

Safety Profile

The safety profile of Qfitlia includes warning for serious thrombotic event and acute and recurrent gall bladder disease. The most common treatment-emergent adverse event in the fitusiran group was increased alanine aminotransferase levels, observed in 32% of participants.

Benefits for Patients

Qfitlia represents a paradigm shift in haemophilia care by combining effective bleed protection with infrequent dosing and simplified administration. “This approval highlights our commitment to advancing innovation and improving care for the rare blood disorders community,” said Brian Foard, executive vice president at Sanofi Tanya Wroblewski, MD, deputy director at the FDA’s Center for Drug Evaluation and Research, emphasized that this therapy “can be administered less frequently than other existing options,” improving quality of life for patients.

Conclusion

The FDA’s approval of Qfitlia marks a transformative moment for individuals living with haemophilia A or B. By offering effective bleed prevention with minimal treatment burden, this innovative therapy has the potential to significantly improve patient outcomes and redefine standards of care worldwide.

References

1. FDA Approves Novel Treatment for Haemophilia A or B, with or without Factor Inhibitors, US Food and Drug Administration, 28 March 2025, available form https://www.fda.gov/news-events/press-announcements/fda-approves-novel-treatment-Haemophilia-or-b-or-without-factor-inhibitors

2. Press Release: Qfitlia approved as the first therapy in the US to treat Haemophilia A or B with or without inhibitors, Sanofi, 28 March 2025, available from https://www.sanofi.com/en/media-room/press-releases/2025/2025-03-28-20-07-38-3051637

3. Castaman G, Matino D. Haemophilia A and B: molecular and clinical similarities and differences. Haematologica. 2019 Sep;104(9):1702-1709. doi: 10.3324/haematol.2019.221093. Epub 2019 Aug 8. PMID: 31399527; PMCID: PMC6717582.

4. Mannucci PM, Franchini M. Is haemophilia B less severe than haemophilia A? Haemophilia. 2013 Jul;19(4):499-502. Doi: 10.1111/hae.12133. Epub 2013 Mar 21. PMID: 23517072.

5. Meeks SL, Batsuli G. Haemophilia and inhibitors: current treatment options and potential new therapeutic approaches. Haematology Am Soc Hematol Educ Program. 2016 Dec 2; 2016(1):657-662. Doi: 10.1182/asheducation-2016.1.657. PMID: 27913543; PMCID: PMC6142469.

6. Treatment of Haemophilia, US Centre for disease control and prevention, 13 Nov 2024, available from https://www.cdc.gov/Haemophilia/treatment/index.html

7. Miesbach W, Schwäble J, Müller MM, Seifried E. Treatment Options in Haemophilia. Dtsch Arztebl Int. 2019 Nov 22; 116(47):791-798. Doi: 10.3238/arztebl.2019.0791. PMID: 31847949; PMCID: PMC6937545.

8. Von Drygalski A., Giermasz A., Castaman G., Key N.S., Lattimore S., Leebeek F.W.G., Miesbach W., Recht M., Long A., Gut R., et al. Etranacogene Dezaparvovec (AMT-061 Phase 2b): Normal/near Normal FIX Activity and Bleed Cessation in Haemophilia B. Blood Adv. 2019;3:3241–3247. Doi: 10.1182/bloodadvances.2019000811.

9. Mehta P, Reddivari AKR. Haemophilia. [Updated 2023 Jun 5]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK551607/

10. Qfitlia (fitusiran) injection, Highlights Of Prescribing Information, Genzyme Corporation, A Sanofi Company, available from https://products.sanofi.us/qfitlia/qfitlia.pdf

11. Young G, Srivastava A, Kavakli K, et al, Rangarajan S. Efficacy and safety of fitusiran prophylaxis in people with haemophilia A or haemophilia B with inhibitors (ATLAS-INH): a multicentre, open-label, randomised phase 3 trial. Lancet. 2023 Apr 29;401(10386):1427-1437. Doi: 10.1016/S0140-6736(23)00284-2. Epub 2023 Mar 29. PMID: 37003287.

12. Srivastava A, Rangarajan S, Kavakli K, et al, Fitusiran prophylaxis in people with severe haemophilia A or haemophilia B without inhibitors (ATLAS-A/B): a multicentre, open-label, randomised, phase 3 trial. Lancet Haematol. 2023 May;10(5):e322-e332. Doi: 10.1016/S2352-3026(23)00037-6. Epub 2023 Mar 29. PMID: 37003278.

 

VHL Welireg

EMA Approves Welireg (Belzutifan): A Breakthrough for VHL-Associated Tumors and Advanced Kidney Cancer

by with No Comment Disease & DrugsNew Drug Approval

Written By Yogita Bhadane, B.Pharm

 Reviewed and Fact Checked by Vikas Londhe M.Pharm (Pharmacology)

VHL Welireg

Introduction
Welireg (belzutifan), a significant advancement, has been approved by the European Medicines Agency (EMA) as the first clinically approved pharmaceutical therapy for tumors associated with von Hippel-Lindau (VHL) disease and for adults with advanced renal cell carcinoma (RCC) who have already received treatment. As a new targeted therapy for unmet medical needs, this approval holds promise for clinicians treating these difficult conditions.

Understanding VHL Disease and RCC

Von Hippel-Lindau disease (VHL) is a rare genetic disorder that predisposes people to develop tumors and cysts in the kidneys, pancreas, and central nervous system, with kidney cancer being the most common type. Renal cell carcinoma occurs in an abnormal 70% of individuals with VHL syndrome. These tumors are caused by mutations in the VHL gene, which affects how the gene regulates the breakdown of proteins called hypoxia-inducible factor (HIF), which are sensitive to tissue oxygen levels. Tumor formation results from aberrant HIF activation brought on by VHL mutation. Conventional management techniques involved frequent surgical procedures and constant monitoring, which increased risks and lowered patient living standards. Immunocheckpoint inhibitors and anti-angiogenic therapies are used in the treatment of advanced renal cell carcinoma; however, post-progression care options are still scarce.

Hemangioblastomas

These non-cancerous growths mostly appear in the retina, spinal cord, and brain tissue. Brain hemangioblastoma patients are more likely to experience symptoms like headaches, vision issues, and neurological impairments.

Renal Cell Carcinomas (RCC)

The risk of kidney cancer, primarily clear cell renal carcinoma, is increased in people with VHL disease. In addition to renal impairment, these disorders often manifest bilaterally and cause hematuria and dysuria. Some examples show that (heterogeneous) petrocalcic deposits give rise to saddle-shaped inclusions.

 Pheochromocytomas:

High blood pressure, headaches, sweating, and palpitations are some of the symptoms caused by these tumors growing on the adrenal gland, which strictly adhere to EPI while binding to norepinephrine. Although phenochromocytomas usually appear as benign tumors, if left untreated, they have the potential to become fatal.

 Pancreatic Cysts and Tumors:

Patients with VHL may develop pancreatic cysts. Although the majority of them are benign, tiny molecules have the potential to develop into pancreatic neuroendocrine tumors, which may release hormones that result in various symptoms.

 Endolymphatic Sac Tumors (ELSTs):

Almost all of these are tumors that are located in the patient’s ear near the inner ear. Tinnitus, instability, and hearing loss are possible symptoms for those who have this condition. Chemotherapy or even stereotactic radiation may be used to treat general growth and low-grade ELSTs.

 Retinal Angiomas:

Hemangioblastomas, also known as retinal angiomas, are tumors of the blood vessels that frequently develop in the membrane of the eye and can cause partial blindness. Hemangioblastomas appear when they cause bleeding or retinal detachment, or when they are discovered during an eye exam.

Welireg’s Mechanism:

Angiogenesis (the formation of blood vessels), erythropoiesis (the production of red blood cells), and tumor growth are all regulated by HIF-2α.
The Von Hippel-Lindau (VHL) protein breaks down HIF-2α under normal oxygen conditions.
HIF-2α builds up in tumors that lack VHL, such as clear cell renal cell carcinoma and von Hippel-Lindau disease-associated tumors, which causes the tumor to grow out of control.

 Blocking HIF-2α Dimerization with HIF-1β:

By binding specifically to HIF-2α, belzutifan stops it from interacting with HIF-1β, which is a prerequisite for HIF-2α to activate target genes.
VEGF (vascular endothelial growth factor), PDGF (platelet-derived growth factor), and EPO (erythropoietin) are among the genes involved in tumor survival whose transcription is inhibited by this.

 Anti-Tumor Effects:

Welireg is effective in cancers caused by HIF-2α overactivity, especially VHL-associated renal cell carcinoma (RCC), central nervous system hemangioblastomas, and pancreatic neuroendocrine tumors, because it inhibits HIF-2α signaling, which in turn reduces tumor growth, angiogenesis, and erythropoiesis.

An important tumor growth pathway is disrupted by the oral hypoxia-inducible factor 2 alpha (HIF-2α) inhibitor belzutifan. HIF-2α builds up in low oxygen environments, activating genes that support angiogenesis and cell division. Welireg deprives tumors of these signals by blocking HIF-2α, which slows growth and causes shrinkage. This mechanism is revolutionary because it provides a precision medicine approach that is specific to the molecular drivers of RCC and VHL.

Clinical Trial Efficacy

VHL-Associated Tumors: Belzutifan is being evaluated in patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC) in the Phase 2 open-label clinical trial NCT03401788 (Study 004). 61 adults with at least one detectable RCC tumor and a germline VHL alteration were enrolled. Additionally, patients may have pancreatic neuroendocrine tumors (pNETs) or CNS hemangioblastomas. Prior use of HIF-2α inhibitors, systemic therapy, surgical necessity, and metastatic disease were excluded. Until toxicity or progression, participants were given 120 mg of belzutifan every day. Overall response rate (ORR), the main outcome, was 49% in RCC, 63% in CNS hemangioblastomas, and 83% in pNETs. With more than half of respondents continuing to respond for more than 12 months, the median response duration was not reached.

Advanced RCC: Belzutifan, a hypoxia-inducible factor 2α (HIF-2α) inhibitor, is being evaluated in patients with advanced solid tumors as part of the LITESPARK-001 trial (NCT02974738), a phase 1 clinical study. 55 patients with advanced ccRCC who had previously received treatment were given 120 mg of belzutifan orally once daily as part of this cohort. The objective response rate (ORR), which included one complete response and thirteen partial responses, was 25% following a median follow-up of more than three years. The median progression-free survival (PFS) was 14.5 months, and the disease control rate (DCR) was 80%. Anaemia (24% grade 3) and hypoxia (13% grade 3) were the most common treatment-related adverse events; no grade 4 or grade 5 treatment-related adverse events were noted. These findings show that belzutifan has a manageable safety profile and long-lasting antitumor activity in patients with ccRCC who have received extensive pre-treatment.

Glioblastoma (GBM) Cohort: A cohort of 25 patients with recurrent IDH wild-type glioblastoma after radiation therapy and temozolomide was also included in the trial. Belzutifan 120 mg was given orally to the patients twice a day. There were no objective responses after a median follow-up of 1.9 months; the median PFS was 1.4 months, and the clinical benefit rate was 8%. Every patient had at least one adverse event, and 60% of them had grade 3-5 events. Anaemia (64%), exhaustion (52%), headache (32%), and muscle weakness (32%), were the most frequent adverse events. There were no deaths brought on by the treatment. These results imply that in this GBM cohort, belzutifan did not exhibit antitumor activity.
Belzutifan’s potential for treating advanced ccRCC is generally highlighted by the LITESPARK-001 trial, but its effectiveness in treating GBM has not yet been established.

Safety and Tolerability

Administration of Welireg during pregnancy can cause embryo-fetal harm. It was highly recommended to confirm the pregnancy status before initiating Welireg.

Anaemia (71%), Hypoxia (48%), and nausea (31%), which are usually mild to moderate, are common side effects. It is advised to regularly check oxygen and hemoglobin levels. When compared to intravenous treatments, the ease of oral administration (120 mg once daily) improves patient adherence.

EMA Approval and Patient Impact

With the EMA’s support, access is made possible throughout the EU, changing the way that care is provided. Welireg preserves organ function and quality of life for VHL patients by lowering the need for invasive surgeries. It closes a crucial gap left by post-standard therapies for advanced RCC. “Belzutifan represents a paradigm shift, offering a non-invasive option with meaningful clinical benefits,” says oncologist Dr. Maria Ruiz.

 Future Directions

Belzutifan is being studied for combination treatments and other cancers driven by HIF-2α. Its success highlights how hypoxia pathways can be targeted in oncology.

Conclusion
The approval of Welireg, which addresses long-standing issues in the management of VHL and RCC, is a victory for precision medicine. Belzutifan sets a new standard by focusing on innovation in rare and complex cancers and coordinating treatment with disease biology. This milestone opens the door for future advancements in targeted therapies in addition to providing immediate clinical benefits.

References:

1. First medicine to treat rare genetic disorder causing cysts and tumours, European Medicine Agency, 13 December 2024

2. WELIREG® (belzutifan) Receives First European Commission Approval for Two Indications, Merck, 18 February 2025

3. Kim E, Zschiedrich S. Renal Cell Carcinoma in von Hippel-Lindau Disease-From Tumor Genetics to Novel Therapeutic Strategies. Front Pediatr. 2018 Feb 9;6:16. doi: 10.3389/fped.2018.00016. PMID: 29479523; PMCID: PMC5811471.

4. Ashouri K, Mohseni S, Tourtelot J, Sharma P, Spiess PE. Implications of Von Hippel-Lindau Syndrome and Renal Cell Carcinoma. J Kidney Cancer VHL. 2015 Sep 25; 2(4):163-173. Doi: 10.15586/jkcvhl.2015.41. PMID: 28326271; PMCID: PMC5345519.

5. Eric Jonasch, Frede Donskov, Othon Iliopoulos, Belzutifan for Renal Cell Carcinoma in von Hippel–Lindau Disease, n engl j med 385;22, November 25, 2021.

6. Hu, J., Tan, P., Ishihara, M. et al.Tumor heterogeneity in VHL drives metastasis in clear cell renal cell carcinoma. Sig Transduct Target Ther8, 155 (2023). https://doi.org/10.1038/s41392-023-01362-2

7. Roy E. Strowd et al., Phase 1 LITESPARK-001 study of belzutifan in advanced solid tumors: Results of the glioblastoma cohort. JCO 42, 2054-2054(2024). DOI:10.1200/JCO.2024.42.16_suppl.2054

epv

Earth Day Spotlight: How Ecopharmacovigilance Protects the Planet from Pharmaceutical Pollution

by with No Comment Disease & DrugsResearch

Medically Written and Reviewed by Vikas Londhe M.Pharm (Pharmacology)

epv

As we honour Earth Day and reflect on our collective duty to protect the environment, a lesser-known but critical issue deserves the spotlight: Ecopharmacovigilance. In the era where much attention is given to industrial emissions and plastic waste, Very few people are aware of the silent threat created by pharmaceuticals entering the ecosystems. That’s where ecopharmacovigilance comes in

What is Ecopharmacovigilance?

Pharmaceuticals are meant to be developed for the consumption of humans; however, once humans consume pharmaceuticals, the by-products or remains are excreted into the environment in different ways, and once they enter the environment, they start polluting nature and harming the aquatic animals and other species, including soil and trees. Hence, where pharmacovigilance is the detection and understanding of the side effects of pharmaceuticals on humans, ecopharmacovigilance refers to the science and activities related to the detection, evaluation, understanding, and prevention of adverse effects or other problems related to the presence of pharmaceuticals in the environment. On a broader scale, it is monitoring the presence of pharmaceuticals in the environment, assessing the impact on non-target organisms, understanding it thoroughly, and developing the preventive strategies in a way that any harm to nature due to the presence of pharmaceuticals in the environment should be avoided timely and appropriately.

According to the World Health Organization, treated sewage water, surface water, drinking water, groundwater, sediment, soil, and biota contain hundreds of pharmaceuticals. Increasing use of drugs worldwide, and some of them are resistant to degradation, are the main reasons behind their presence in harmful quantities in nature. The most notable pathways of these pharmaceuticals are excretion of used drugs, drug manufacturing, industrial and home wastewater, aquaculture, manure application, landfills, and incineration.

Why Should We Care?

While pharmaceuticals are essential for human and animal health, their unintended environmental footprint is becoming increasingly evident. Studies have shown:

Increasing Antibiotic Resistance: Antibiotic resistance, or antimicrobial resistance (AMR), poses a global threat due to the irrational use of antibiotics; however, the presence of antibiotics in the environment makes the condition worse, as the exposed antibiotics in open environments make bacterial infections hard to treat. AMR caused an estimated 1.27 million deaths globally in 2019.

Effect on aquatic life: As most of the drugs end up in aquatic bodies like rivers, streams, ponds, and oceans through pathways mentioned above, they are not designed to be there or show a positive effect on wildlife present in waters. They show a negative effect on aquatic animals like fish and affect their ability to reproduce, cause behavior changes, or have direct toxic effects. Hormonal drugs, like estrogens from contraceptives, are supposed to be causing these types of effects. Some reports show that male fish were feminized by ethinyl estradiol and frogs were killed by contraceptive tablets. Psychiatric and cardiovascular drugs have been linked to altered behavior and physiological changes in aquatic animals. Some reports related to it show that aggression is caused in lobsters due to antidepressants and spawning in shellfish by fluoxetine.

Current Status of Ecopharmacovigilance

Regulatory Recognition

The OECD report Pharmaceutical Residues in Freshwater: Hazards and Policy Responses highlights the growing concern over pharmaceutical contamination in global freshwater systems due to human and veterinary use, manufacturing, and improper disposal.

The report emphasizes the need for a life cycle, multi-sectoral approach involving source-directed, use-oriented, and end-of-pipe solutions. This includes better monitoring, green pharmaceutical design, responsible prescription and use, proper disposal systems, and advanced wastewater treatment.

International Cooperation Needed: The report also emphasizes the importance of data sharing, international standards, public education, and financial strategies to implement sustainable pharmaceutical pollution control.

EMA and FDA integrated environmental risk assessments (ERAs) into the drug approval process

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have taken significant steps to integrate Environmental Risk Assessments (ERAs) into the drug approval process, marking a growing recognition of the environmental impact of pharmaceuticals.

Environmental risk assessments evaluate the potential environmental impact of a pharmaceutical substance once it enters ecosystems, typically through human excretion, improper disposal, or manufacturing waste. These assessments analyze factors such as persistence in the environment, bioaccumulation in wildlife, toxicity to aquatic and terrestrial organisms, and potential for environmental transformation into harmful by-products.

Since 2005, the EMA has required ERAs for all new marketing authorization applications in the EU.

The FDA has also implemented environmental reviews under the National Environmental Policy Act (NEPA). For human drugs, applicants typically submit an Environmental Assessment (EA) or a claim for categorical exclusion, depending on the drug’s characteristics. The FDA assesses factors such as expected introduction into the environment, manufacturing and disposal practices, and the cumulative impact of widespread use.

As awareness of pharmaceutical pollution grows, both agencies are expected to tighten guidelines, enhance transparency, and collaborate internationally on standardized ERA methodologies. This reflects a shift toward sustainable drug development that balances therapeutic benefit with environmental responsibility.

What Can You Do?

On Earth Day and every day individuals can play a role in supporting ecopharmacovigilance:

Proper Medication Disposal

Don’t flush unused meds in the toilet or sink.

Use take-back programs: Many pharmacies and communities have medication disposal programs.

If no programs are available, follow the FDA’s or local authority’s guidelines for trash disposal (e.g., mix with unpalatable substances like coffee grounds or cat litter, then seal in a bag).

Buy Only What You Need

Avoid stockpiling medications. It reduces waste and environmental load from expired drugs.

Use Medications Responsibly

Follow prescriptions exactly—using less or more than necessary not only harms health but also leads to excess drugs in the environment.

Spread Awareness

Talk to friends and family about why proper disposal matters

Share posts or articles about EPV and pharmaceutical pollution.

Ask Your Pharmacist

If unsure about disposal or environmentally safer alternatives, ask to your pharmacist. Pharmacist is the healthcare provider who is easily accessible compare to other HCPs. Added to it possesses good knowledge about medicine use and disposal. So some may offer eco-friendly info or take-back services.

Support Green Pharmacies

Support pharmacies and drug companies who are committed to reducing environmental impact (e.g., sustainable packaging, greener drug production).

Advocate for Change

Encourage local governments and health organizations to implement and promote better environmental drug policies.

Avoid Unnecessary Use of Over-the-Counter Drugs

Many people take OTC drugs like painkillers or antacids unnecessarily. This leads to increased production, use, and environmental excretion.

Looking Ahead

Ecopharmacovigilance is still evolving, but it’s becoming an essential part of environmental health strategies. With collaborative efforts from the healthcare industry, regulators, and the public, we can reduce the ecological footprint of lifesaving medicines.

References:

1. Ecopharmacovigilance: Ensuring Environmental Safety from Pharmaceuticals, Uppsala Reports, 15 Oct 2024, available form https://uppsalareports.org/articles/ecopharmacovigilance-ensuring-environmental-safety-from-pharmaceuticals/

2. The Impact of Pharmaceuticals Released to the Environment, United state environmental Protection Agency.

3. Dutta A, Banerjee A, Chaudhry S. Ecopharmacovigilance: Need of the hour. Indian J Pharm Pharmacol 2022;9(2):77-80.

4. Eapen JV, Thomas S, Antony S, George P, Antony J. A review of the effects of pharmaceutical pollutants on humans and aquatic ecosystem. Explor Drug Sci. 2024; 2:484–507. https://doi.org/10.37349/eds.2024.00058

5. OECD (2019), Pharmaceutical Residues in Freshwater: Hazards and Policy Responses, OECD Studies on Water, OECD Publishing, Paris, https://doi.org/10.1787/c936f42d-en

6. Paut Kusturica M, Jevtic M and Ristovski JT (2022), minimizing the environmental impact of unused pharmaceuticals: Review focused on prevention. Front. Environ. Sci. 10:1077974. Doi: 10.3389/fenvs.2022.1077974

7. Guideline on the environmental risk assessment of medicinal products for human use, Committee for Medicinal Products for Human Use (CHMP), European Medicine Agency.

8. Environmental Impact Review at CDER, 07 Jan 2025, US Food and Drug Administration, available fromhttps://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/environmental-impact-review-cder