Latest news with #DrugSafety
Medscape
08-07-2025
- Health
- Medscape
MHRA Advises on Rare GBS Risk After RSV Vaccination
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Drug Safety Update concerning Guillain-Barré syndrome (GBS) following the administration of respiratory syncytial virus (RSV) vaccines. Healthcare professionals are advised to inform recipients of Abrysvo (Pfizer) and Arexvy (GSK) about potential symptoms of GBS. Should these occur, recipients should seek immediate medical care, as early intervention can reduce severity and improve outcomes. GBS is an acute demyelinating disease that affects the peripheral nervous system. It has previously been reported in response to several vaccines, including those for influenza, swine flu, SARS-CoV-2, meningococcal disease, poliovirus, and rabies. Symptoms usually start in the limbs and include tingling, numbness, or pins and needles in the feet and hands, followed by muscle weakness and difficulty moving joints. Severe Cases May Include Paralysis In more serious cases, patients may experience shooting nerve pain, often in the legs or back, breathing difficulties, drooping facial muscles, problems with swallowing or speech, and double vision. Some may develop paralysis in the legs, arms, or face. Treatment typically requires hospitalisation for several weeks or months. Therapies include immunotherapy and symptomatic management. GBS can be fatal in rare instances. Study Suggests Increased Risk Post-Vaccination The MHRA alert follows a US study evaluating GBS risk in adults aged over 65 after receiving RSV vaccines. The study, led by the US Food and Drug Administration and data analysis company Acumen in California, was conducted as a self-controlled case series analysis between 3 May 2023 — when the vaccines were first approved in the US — and 28 January 2024. The study involved approximately 3.23 million Medicare recipients who received either Abrysvo or Arexvy. The researchers compared the incidence of GBS during risk intervals of 1-42 days after vaccination — when most reactions occur — to the incidence in later control periods (43-90 days). Ninety-five GBS cases were reported in the early period. The incidence rate ratio (IRR) ranged from 2.02 to 2.46, translating to 6.5-9 additional cases per 1 million vaccine doses. However, statistical significance was only reached in the Arexvy group. In the UK, Abrysvo is the RSV vaccine offered through the NHS to adults aged 75-79 and to pregnant women. As of 2 June 2025, the MHRA had received 21 Yellow Card reports of suspected GBS in older adults following Abrysvo vaccination. This was out of more than 1.9 million doses of Abrysvo administered up to 26 May on the NHS scheme. There have been no Yellow Card reports of GBS following Arexvy in the UK, probably due to limited use. Arexvy is not used in the NHS but may be accessed privately by adults over 60, or those aged 50-59 at higher risk. Arexvy is not recommended for use in pregnancy. However, the MHRA said that there was currently no evidence that Abrysvo increased GBS risk in pregnant women. The MHRA reported that, among over a quarter of a million doses of Abrysvo given to pregnant women up to 26 May 2025, there had been no Yellow Card reports of suspected GBS. Risk Remains Rare, Says MHRA The MHRA emphasised that the risk of GBS from RSV vaccines remains rare. Early, unpublished data from post-marketing surveillance by the UK Health Security Agency and Public Health Scotland estimated a combined excess of 15-25 GBS cases per million doses of Abrysvo given to those aged 75-79. The Commission on Human Medicines has reviewed the data and advised that the benefits of RSV vaccination in older adults outweigh the risk of developing GBS. Healthcare professionals and the public are urged to continue reporting suspected adverse reactions associated with Abrysvo and Arexvy through the Yellow Card scheme. Dr Sheena Meredith is an established medical writer, editor, and consultant in healthcare communications, with extensive experience writing for medical professionals and the general public. She is qualified in medicine and in law and medical ethics.
Gizmodo
01-06-2025
- General
- Gizmodo
Stop Using, Start Itching: FDA Flags Risk Tied to Popular Allergy Med Zyrtec
Two common anti-allergy medications can leave you feeling scratchier than ever. The Food and Drug Administration is warning that stopping long-term use of cetirizine and levocetirizine can, in rare cases, cause intense itchiness. The FDA issued its warning earlier this month. Over the past decade, the agency has received hundreds of reports of people experiencing severe—sometimes 'debilitating'—itching after going off the medications. Though it appears to be a rare complication, the FDA is also requiring manufacturers to mention the side effect in the labeling of these drugs. 'The underlying mechanism for this risk is unknown, but our evaluation supports a causal relationship between stopping cetirizine or levocetirizine and pruritus,' the FDA stated in its Drug Safety Communication about the products. Cetirizine and levocetirizine are both antihistamine drugs that have been around for a while. The former was first approved as the prescription drug Zyrtec in 1995, while levocetirizine was approved as Xyzal in 2007. Though the drugs can still be prescribed, they're also now widely available over-the-counter to treat hay fever and other allergy symptoms. As useful and safe as these drugs have been for millions of people, whispers of this side effect have been circulating for years. A 2019 study identified potential cases of severe pruritus (itching) related to cetirizine withdrawal dating back to at least 2008, for instance, while a 2016 study reported similar cases in the Netherlands tied to levocetirizine; users have also detailed their unbearable experiences trying to quit these drugs on Reddit and other social media platforms long before the FDA stepped in. While it's possible some people may have had a return of allergy symptoms once they stopped taking these drugs, people commonly reported itching that hadn't existed before or to a degree previously never experienced. The FDA identified 209 cases worldwide (197 in the U.S.) of new-onset pruritus after cetirizine/levocetirizine withdrawal between April 2017 and July 2023. Most people had taken the medications for over three months, often years, though cases could also occur after only one month of continuous use. Sufferers typically complained of widespread itching that required medical intervention; in some cases, the itching was so severe that it left people bedridden or even led to thoughts of suicide or self-harm. The silver lining is that this side effect seems to be rare overall. The FDA notes that about 100 million prescriptions or OTC purchases of both drugs combined were made in 2022. People with the side effect aren't necessarily doomed to itch forever, either. The FDA found that 90% of people who restarted their medication resolved their itching, for instance, and about one-third of people were able to avoid a new bout of itching if they slowly weaned off the drug once restarting. Some people have also reported relief after taking a short course of corticosteroids. Still, if you're a longtime user of these drugs, this is certainly something to be aware of in case you ever decide to stop. People planning to take these drugs long term should also discuss the benefits and risks of doing so with their doctor, the FDA said, 'who can provide advice based on your personal needs.'
Scroll.in
17-05-2025
- Health
- Scroll.in
Indian academia is rife with research and publishing misconduct
In July 2021, the Bengaluru-based National Centre for Biological Sciences withdrew a paper published in Nature Chemical Biology, a premier journal, after discovering instances of data manipulation. The study, which announced a breakthrough in chemical biology, was withdrawn after being found to have manipulated images. In September 2024, the journal Drug Safety retracted a study conducted by researchers from Banaras Hindu University on the long-term safety of Covaxin, India's indigenous Covid-19 vaccine. The withdrawal was due to concerns that the reported adverse events could lead to ambiguous or incorrect interpretations regarding the vaccine's safety. In close to two decades now, faculty members from the premier Indian Institutes of Technology have retracted a staggering 58 papers, primarily due to plagiarism and duplication. As India strives towards Viksit Bharat 2047 – the goal of becoming a developed nation – strengthening research integrity, research funding and innovation ecosystems will be crucial. However, rising cases of research misconduct, including plagiarism, data fraud and fake peer review, pose a serious threat to this vision. Research misconduct refers to unethical practices in conducting, reporting or reviewing research. Such misconduct often leads to retractions. According to Retraction Watch, a global database, common reasons for retraction include fraud and misconduct, ethical violations, errors and mistakes, publication issues, and legal and policy violations. Such unethical practices not only damage the credibility of Indian institutions but also erode trust in research, affecting international collaborations and funding opportunities. Addressing these challenges requires urgent reforms in research evaluation, stronger institutional oversight and a shift towards quality-driven academic assessments. Research, rising retractions India's research output has increased rapidly over the past decade, with hundreds and thousands of papers published annually in reputed journals. Th National Science Foundation, 2022 report ranks India as the third-largest producer of science and engineering articles, after China and the United States. According to the scientific abstract and citation database Scopus, India has produced 3.67 million papers since 1867. Of these, 3,446 (0.09%) are retracted. While the growth of research is promising, the rising number of retractions is concerning. A study by this author shows primary causes of retractions are plagiarism, data fraud and fake peer review. Retractions due to these increased by 6.3% from 1991-2000 to 2001-2010. The upward trend has continued: retractions rose by 32% from 2001-2010 to 2011-2020. Quantity over quality When a scientist's survival is determined by impact factors, ethics becomes the privilege of a few who can afford to be ethical', said a scientist at the University of Pune, who was quoted in an article on research misconduct in India. Impact factor refers to the average number of citations to recent articles published in a journal, indicating the journal's influence in an academic field. Publishing in high impact factor journals translates into appointments, promotions, institution rankings and research grants. And here lies the root of the problem – evaluating scientific success by over-relying on impact factors, publication counts and rankings among organisations. This creates immense pressure, pushing researchers toward unethical practices. There are comprehensive guidelines of the Committee on Publication Ethics –a non-profit organisation that provides guidance to editors and publishers on all aspects of publication ethics, especially research and publication misconduct – and mandatory research ethics courses for students before they start PhD programmes. But whether the practices outlined by these efforts are genuinely practiced and embraced, or treated merely as formalities, remains a subject of debate. One of the primary reasons for the rising pressure on academics is the 'publish or perish' culture, where academic promotions and funding are heavily tied to publication volume rather than research quality. This intense pressure pushes some researchers toward unethical shortcuts, including plagiarism, fake peer review and data fabrication. This author's study revealed that fake peer review is the leading cause of retractions in India, accounting for 33% of total cases, followed by data fraud (17.2%) and plagiarism (14.8%). Among higher education institutions/universities, private institutions contributed to 60 percent of retractions, while public institutions accounted for 33.7%, and medical institutions made up 6.7%. Enforcing research integrity Without urgent and necessary changes in research evaluation and academic incentives, addressing research misconduct will remain a significant challenge. The presence of legally enforceable misconduct policies and a strong academic culture where research undergoes rigorous scrutiny from peers, mentors, and society, can serve as deterrents for such misconduct. Countries that offer cash rewards for publications may appear to encourage researchers, but ironically face a higher risk of misconduct. This suggests that such incentives might encourage negligence or unethical practices within the research community. Addressing research misconduct thus requires a multifaceted approach that respects the autonomy of researchers while establishing clear boundaries against unethical practices. In India, given the diverse research ecosystems and financial structures across Indian institutions, implementing a uniform national solution is challenging. The University Grants Commission recently discontinued the UGC-CARE (Consortium for Academic and Research Ethics) system of listing quality journals. The idea is to move towards a decentralised approach – empowering individual institutions to set their own criteria for journal selection, fostering academic freedom and encouraging more rigorous and context-specific evaluations. The reasons cited for the discontinuation include a number of poor quality journals and pay-and-publish or predatory journals which had found their way into the list, while several Indian language journals were left out. The new system allows for a broader range of journals – based on certain parameters – for the faculty to publish in. Indian institutions need to develop and enforce comprehensive research integrity policies, including mandatory training in research ethics. Establishing dedicated committees to oversee research conduct can also ensure adherence to ethical standards. Promoting open peer review processes and encouraging researchers to share data and methodologies can enhance transparency and accountability in research. Such practices deter misconduct by subjecting research to broader scrutiny. Kiran Sharma is Assistant Professor at the School of Engineering and Technology, BML Munjal University. She also leads the Center for Advanced Data and Computational Science. Her research integrates data science, the science of science, computational social science, machine learning and network science.
