Latest news with #Pharmacovigilance
Russia Today
an hour ago
- Health
- Russia Today
Popular weight loss drug could cause sudden blindness – EU's health watchdog
The European Medicines Agency (EMA) has concluded that semaglutide-based medications – including Ozempic, Wegovy, and Rybelsus – increase the risk of a serious eye condition that can lead to sudden vision loss. Following a comprehensive safety review, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) determined that non-arteritic anterior ischemic optic neuropathy (NAION) should be listed as a 'very rare' side effect of semaglutide – the main component of weight-loss and anti-diabetic drugs produced by Novo Nordisk. The EMA's review, initiated in January 2025, analyzed data from clinical trials, post-marketing surveillance, and medical literature. Findings suggest that adults with type 2 diabetes taking semaglutide have approximately twice the risk of developing NAION compared to those not on the medication. On Friday, the EU's health watchdog recommended updating the product information for semaglutide-containing medicines to include NAION as a potential side effect. The 'very rare' classification indicates that the condition may affect up to 1 in 10,000 users. NAION is the second most common cause of optic nerve-related blindness after glaucoma. Patients experiencing sudden vision loss or rapidly worsening eyesight while on semaglutide are advised to seek immediate medical attention and discontinue use if NAION is diagnosed. The Denmark-based company Novo Nordisk owns the patent on semaglutide, a GLP-1 receptor agonist used for managing type 2 diabetes and obesity. It functions by enhancing insulin secretion and promoting a feeling of fullness, thereby aiding in blood sugar control and weight management. A recent study also indicated that Ozempic and similar medications may increase the risk of kidney cancer. However, the drugs reportedly lower the risk of more than a dozen other cancers, suggesting their overall benefit may still outweigh the hazards. Additionally, the EMA previously investigated reports of suicidal thoughts associated with semaglutide use, though no definitive causal relationship was established. The EMA's recommendations will now be reviewed by the Committee for Medicinal Products for Human Use (CHMP) before a final decision is adopted by the European Commission. Novo Nordisk, which was dethroned as Europe's most valuable company earlier this year, has stated its commitment to patient safety and is working with the EMA to update product labels accordingly.
Mint
23-05-2025
- Health
- Mint
Govt alert: common antibiotic treatment may be ‘life threatening'
New Delhi: The Indian Pharmacopoeia Commission (IPC), a body under the health ministry, has found a commonly used antibiotic combination—sulfamethoxazole and trimethoprim—to have shown serious adverse reactions. This fixed dose combination drug is a popular antimicrobial medication used for the treatment of a wide range of bacterial infections such as pneumonia, bronchitis, skin infection, granuloma, urinary tract infection etc. The commission noted that the drug is showing serious adverse reaction in the form of leukopenia, a life-threatening condition which lowers the white blood cell count. 'The analysis of Adverse Drug Reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database revealed that suspected drug–Sulfamethoxazole + Trimethoprim–used for indication(s) like Urinary Tract infection; Respiratory-tract infection including Bronchitis, Pneumonia, infections in Cystic Fibrosis, Melioidosis, Listeriosis, Brucellosis, Granuloma Inguinale, Otitis Media, Skin infection, Pneumocystis Carinii Pneumonia— is showing adverse drug reaction called Leukopenia,' IPC in a drug alert for the month of May, seen by Mint. IPC asked healthcare professionals, patients and consumers to closely monitor for any adverse reaction with the drug and report to the authorities if such a reaction occurs. Medical experts said that doctors should be cautious when prescribing this combination, especially for vulnerable patients, and regular blood tests can help catch any issues early. 'Trimethoprim-sulfamethoxazole has been used for years to treat a range of common bacterial infections because it's effective and widely available. But the recent alert from the Indian Pharmacopoeia Commission about its link to leukopenia—a drop in white blood cells—is an important reminder that even well-known medicines can have serious side effects. A low white cell count can make it harder for the body to fight infections, especially in older adults or people with weaker immune systems,' said Dr R.R. Dutta, HOD, Internal Medicine, Paras Health Gurugram. The IPC monitors adverse drug reactions among the Indian population and recommends the Central Drugs Standard Control Organization (CDSCO) to take suitable regulatory decisions for safe use of medicines. Earlier, Mint reported that the Drugs Controller General of India has directed states/UTs to keep a close surveillance on the sale of unapproved antibiotic combinations and ensure that these cocktail drugs do not find their way to the market. The plan is to stop the misue of antibiotics. Last year, the IPC issued 10 drug safety alerts. Antimicrobial resistance (AMR), often due to overuse or wrong use of drugs, has emerged as a serious and growing threat to public health across the world, with around 600,000 lives being lost in India each year due to such AMR infections, as per the data available with the ministry of chemical and fertilizer. Queries sent to the health ministry spokesperson remained unanswered. According to Crisil market intelligence and analytics, the market size of the anti-infective segment in India stood at about ₹ 251.3 billion for FY24. These include antibiotics, antivirals, and antifungals.
Yahoo
19-05-2025
- Business
- Yahoo
2 Day Understanding Pharmacovigilance Regulations in Asia Pacific Training Course: Enhance Your PV Strategy with In-Depth Training on RPPV, PSMF, and RMP Requirements (ONLINE EVENT: June 16-17, 2025)
Dublin, May 19, 2025 (GLOBE NEWSWIRE) -- The "Understanding Pharmacovigilance Regulations in APAC Training Course" training has been added to offering. Pharmacovigilance regulations in Asia are dynamic and fast-changing. As the Asia-Pacific region becomes increasingly important for pharmaceutical companies, it's vital to ensure compliance and safety by staying informed of the latest regulatory developments. This two-day pharmacovigilance webinar has been designed to provide a comprehensive guide to compliance in this geographic region. It will provide an ideal opportunity to keep up-to-date with the latest Good Pharmacovigilance Practices (GVP) and post market PV operations in China, and post-market pharmacovigilance regulations in Singapore, Malaysia, the Philippines, and Australia. Our panel of experts from this region will provide an overview of Good Pharmacovigilance Practices and discuss pharmacovigilance-related requirements. Gain key takeaways to better understand the new GVP regulations and pharmacovigilance compliance in these countries. Don't miss this opportunity to learn from industry leaders and enhance your knowledge of dynamic and fast-changing regulations in Asia, and the growing market in the Asia-Pacific region. Benefits of Attending Gain a comprehensive overview of Pharmacovigilance regulations in China, Singapore, Malaysia, the Philippines, and Australia Stay updated with the latest Pharmacovigilance regulations in these countries Enhance your Pharmacovigilance-related knowledge and skills Understand the local requirements for RPPV (QPPV), PSMF, RMP, and other related regulations in each of these countries Certifications: CPD: 6 hours for your records Certificate of completion Who Should Attend: This webinar is intended for anyone involved in and interested in Good Pharmacovigilance Practices (GVP) and the daily practice of pharmacovigilance, including: Professionals working in pharmacovigilance departments Drug safety specialists Adverse reaction monitoring professionals R&D professionals Regulatory affairs specialists Pharmaceutical physicians Key Topics Covered: Day 1 Pharmacovigilance in China - GVP Overview An Overview of China Pharmacovigilance Annual report of China national ADR monitoring China PV concept PV development in China Competent authorities National systems introduction China GVP 2021 Introduction and Requirements Quality management: PV system, quality objective, QA system, QC indicators Organizational structure, personnel, resources: RPPV (QPPV), PV department Monitor and report: data collection, ICSR case processing, report submission, literature search Risk identification and evaluation: incl. PSUR/PBRER, post-marketing safety study Risk control: risk control measures, risk communication, PV plan (RMP) Documentation, record and data management: incl. PSMF PV annual report Brief introduction of clinical PV requirements Best Practices for Compliance with China's GVP Requirements 4 key tips 4 key pitfalls Authority inspection Q&A Post-Market PV Operation PV Operation - Individual Case Study Reports (ICSR) ICSR Overview Adverse Events Collection, Processing, and Submission to Regulatory Authorities National ADR Monitoring System Report Submission Demonstration Periodic Safety Update Report (PSUR)/PBRER Structures and contents Timelines Day 2 Pharmacovigilance Regulations in Singapore, Malaysia, Philippines and Australia Pharmacovigilance Regulations in Malaysia Introduction to Pharmacovigilance in Malaysia and Legal Basis Pharmacovigilance system Responsibilities of MAH, Responsible Person for PV (RPPV), Record Retention Managing ADR/AEFI reports Collection, Validation of reports, ADR reporting systems, Timeframes, and Submission requirements Periodic Benefit-Risk Evaluation (PBRERs) Overview, Format & content of PBRER, Submission requirements, Annexes Risk Management Plans (RMPs) Objective, Structure, Submission requirements, Risk Minimisation activities Pharmacovigilance System Master File (PSMF) Objective, Format & content of PSMF, Annexes Emerging Safety issues, Safety evaluation by NPRA, Safety communications Audits & Inspections Pharmacovigilance Regulations in Singapore Introduction to Pharmacovigilance in Singapore and Legal Basis Responsibilities of the Company Adverse Event reporting Reporting requirements, Records, Special situation reporting Risk Management Plans Submission requirements, Documents, Risk Minimisation activities Periodic Benefit-Risk Evaluation (PBRERs) Reporting requirements Actions taken by Regulatory Authorities Pharmacovigilance Regulations in the Philippines Introduction to Pharmacovigilance in the Philippines and Legal Basis Pharmacovigilance system QPPV Records of PV Reporting of Adverse Reactions Timeframes, Reporting requirements Significant safety Information Risk Management Plan (RMP) Submission requirements, Documents, Risk Minimisation activities Periodic Benefit-Risk Evaluation (PBRERs) Reporting requirements, Format & contents Actions taken by other national drug authorities PV inspections Pharmacovigilance Regulations in Australia Introduction to Pharmacovigilance in Australia Pharmacovigilance system QPPVA and Australian PV contact person APSS (Australian Pharmacovigilance System Summary) DAEN Database Reporting of Adverse Reactions Timeframes, Reporting requirements. Significant safety issues Risk Management Plan (RMP) and Australia Specific Annex (ASA) Submission requirements, Documents, Risk Minimisation activities Periodic Safety Update Reports (PSUR) Reporting requirements, Format & contents Actions taken by other HA's. PV inspections and Pharmacovigilance inspection program (PVIP) Speakers: Raphael Tian Pharmacovigilance Manager Accestra Consulting Mr. Raphael Tian is a seasoned pharmacovigilance Manager at Accestra Consulting, with extensive experience in top global pharmaceutical companies and a focus on the Chinese market. With hands-on experience in Adverse Event monitoring and reporting, Literature screening, Research Related Programs, Market Research and Patient Support Programs, PV agreements, Chinese GVP, and local regulations. Raphael is an experienced trainer in pharmacovigilance with a strong communication network in the local and global pharmaceutical industry in China. Param Dayal Pharma To Market Mr. Param Dayal is a qualified Microbiologist with Master's degree in Microbiology and a certified MedDRA coder. For the last 15 years, Param has worked on a variety of pharmacovigilance projects with special focus on ICSR processing (Unsolicited, solicited, Literature, legal and Clinical trials cases). In his previous roles he worked for organisations supporting pharma clients with PSP program management, PV audits, HA inspections, data migration, SOP Management, process refinement, providing PV training and mentoring to new staff. He also has experience working as a QPPV and Local Safety Officer for Australia and New Zealand. He is currently based in Melbourne working as Drug Safety Manager for Pharma To Market, managing PV activities for NZ clients. Siew Man Phang Pharma To Market Ms. Siew Man Phang is a registered pharmacist in Malaysia, brings over 7 years of pharmacovigilance and regulatory expertise. She has served as QPPV for multinational pharmaceutical, generic, and distributor companies, gaining diverse experience across innovator drugs, generics, biologics, health supplements, traditional products, cosmetic and medical devices. Additionally, she possesses extensive hands-on experience in pharmacovigilance, including adverse event monitoring & reporting, literature & regulatory Intelligence screening, risk management plan, SOP and PSMF writing. She is currently based in Malaysia, works as a Regulatory & Pharmacovigilance Assistant Manager in Pharma To Market handling various pharmaceutical clients, serving as QPPV and managing Pharmacovigilance activities in APAC regions. Marylene Zhan Senior consultant Accestra Consulting Ms. Marylene Zhan is a senior consultant at Accestra Consulting with extensive experience in pharmacovigilance and regulatory affairs, with a Master's Degree from the Zhongnan University of Economics and Law. Marylene is a seasoned bilingual and bicultural consultant who specialises in China regulatory compliance and pharmacovigilance services (RA/PV). She has a wealth of knowledge on Chinese Pharmaceutical regulations and in-depth insight into dealing with Chinese market access requirements. Marylene has a rich experience in serving international pharma companies with market entry into China, providing support in the areas of adverse event monitoring and reporting, literature screening, PV agreements, Chinese GVP and local regulations, SOP & PSMF writing, and more. Helen Ye RA & PV Director Accestra Consulting - Ms. Ye has been dedicated to regulatory affairs consulting for 15 years with a Pharmacy degree from Zhejiang University, China. - She is experienced in regulatory compliance of China market access & post-marketing maintenance of pharmaceutical products, providing insightful and customised solutions to international pharmaceutical companies and government institutions. - She leads the registration team to plan, develop and implement compliance strategies for top pharma clients and has a successful track record for obtaining market approval for drug products, APIs, Excipients, Packaging Materials, medical devices and other products. - Ms. Ye has a strong communication network with Chinese authorities (e.g. NMPA and CDE) and industry experts in China. For more information about this training visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
