The newsletter is structured into three core sections, each highlighting significant safety and regulatory developments.
1. Regulatory Matters
This section details specific regulatory actions and safety reviews undertaken by national health authorities.
- Fluconazole (Antifungal): The European Medicines Agency (EMA) recommended new advice for women of childbearing potential, including a one-week “washout” period after a single dose before pregnancy, due to risks of abnormal pregnancy outcomes.
- Medroxyprogesterone Acetate (Contraceptive/Hormone): The EMA recommended measures to minimize the risk of meningioma (a type of brain tumor) associated with long-term, high-dose use.
- Voxelotor (for Sickle Cell Disease): A major safety concern led to the suspension of its marketing authorization in Europe and a voluntary withdrawal from the US market. This was due to emerging data showing a higher occurrence of vaso-occlusive crises and an imbalance in deaths compared to placebo.
- Varicella-Zoster Virus Vaccine (Shingrix®): Australia updated the product information to recognize Guillain-Barré Syndrome (GBS) as a very rare adverse event.
- Obeticholic Acid (for Liver Disease): The US FDA issued a new warning about the risk of serious liver injury in patients without cirrhosis, expanding on previous warnings for patients with advanced cirrhosis.
2. Safety of Medicinal Products
This section provides important safety communications and updates on potential risks.
- Finasteride/Dutasteride (for Hair Loss & Prostate): The EMA started a review to investigate concerns regarding suicidal ideation and behaviors, building on known psychiatric side effects.
- Valproate (for Epilepsy/Bipolar): New advice was issued concerning paternal exposure. Studies suggest a potential increased risk of neurodevelopmental disorders in children whose fathers took valproate around the time of conception. Male patients are advised to use effective contraception during treatment and for 3 months after stopping.
- Levofloxacin (Antibiotic) – Medication Error: The Egyptian Pharmacovigilance Center (EPVC) issued an alert about incorrect intravenous infusion rates, which led to serious complications like hypotension and anaphylactic reactions. They emphasized the need for slow infusion over 60-90 minutes.
- Doxycycline (Antibiotic): In contrast to the above, the EMA concluded that available evidence is not sufficient to establish a causal link between doxycycline and suicidality.
3. Feature: WHO Global Smart Pharmacovigilance Strategy
This is a significant section outlining the future direction of pharmacovigilance.
- Synopsis of the Strategy: Presented after a partners’ meeting in New Delhi, the strategy advocates for a “Smart” approach to pharmacovigilance. This means countries should focus their limited resources efficiently.
- Four Key Principles:
- Learn from the past: Build on existing systems like the WHO Programme for International Drug Monitoring (PIDM).
- Adopt a risk-based approach: Prioritize monitoring for products unique to a region or those with limited pre-approval data (e.g., products with accelerated approval).
- Promote work-sharing and reliance: Countries should collaborate and rely on each other’s findings instead of duplicating efforts.
- Integrate PV into regulatory strengthening: Use tools like the WHO Global Benchmarking Tool (GBT) to systematically improve national regulatory systems.
