This is the 19th volume, 11th issue of the EPVC’s monthly newsletter, published in November 2025. It serves as an official communication from the Egyptian Drug Authority (EDA) to healthcare professionals, regulators, and the public regarding drug safety, pharmacovigilance activities, and regulatory updates in Egypt.
Main Sections & Content Breakdown
1. EPVC Mission Statement
- The EPVC is part of the Central Administration of Pharmaceutical Care under the EDA.
- Its mission is to oversee the authorization, regulation, monitoring, and evaluation of pharmaceutical products and medical devices in Egypt.
- It also disseminates safety information to protect public health.
2. Prescriber Guide: Systemic Retinoids and DISH
- Topic: Link between systemic retinoids (e.g., isotretinoin, acitretin) and Diffuse Idiopathic Skeletal Hyperostosis (DISH).
- Key Points:
- DISH is a non-inflammatory condition causing abnormal bone growth, mainly in the spine.
- Most patients are asymptomatic until advanced stages.
- Long-term/high-dose retinoid use may promote bone formation, leading to DISH.
- Reference: Based on a guide from New Zealand’s regulatory authority.
3. Local Case Safety Report: Illegal Dietary Supplements for Weight Loss
- Issue: Multiple serious adverse events reported from illegally imported weight-loss supplements sold via social media, fitness centers, and unlicensed vendors.
- Reported Serious Adverse Events:
- Cardiovascular: dilated atrium, mitral valve regurgitation, severe hypotension, tachycardia.
- Others: shortness of breath, dizziness, weakness, GI issues, abnormal weight gain after discontinuation.
- Key Risks:
- Undeclared APIs like sibutramine (banned due to cardiovascular risks).
- Cardiovascular, neuropsychiatric, and GI toxicities.
- Counterfeit products with toxic contaminants.
- Recommendations:
- Healthcare professionals should suspect supplement use in unexplained symptoms.
- Report adverse events to EPVC.
- Verify product registration via official EDA platforms.
4. Potential Signal: Angina Pectoris with Ocrelizumab
- Signal Detection: Based on 54 global cases (VigiBase) up to October 2025.
- Background: Ocrelizumab is used for multiple sclerosis.
- Findings: Possible link to angina pectoris, especially in patients with infusion-related reactions.
- Actions: EPVC will implement risk minimization and collect more data.
5. Safety Signal: Seizures with Pipazetate Overdose
- Issue: Seizures reported mainly in children aged 6 months to 3 years following overdose.
- Action Taken: EDA restricted use in children under 4 years and updated the product leaflet.
- Recommendation: Aligns with FDA advice against OTC cough medicines in young children.
6. EPVC News
- ISoP Cairo 2025 Conference: EDA representatives presented on drug safety monitoring and AI in pharmacovigilance.
- Together for Safer Medicine Initiative: 47 participants from 16 governorates submitted 158 adverse drug reaction (ADR) reports.
- BE-Vigilant Initiative: Training for 76 PV focal points from specialized medical centers.
- Agile Mindset for Growth 2025–2026: Initiative to engage medical students in pharmacovigilance.
- MedSafety Week 2025: Awareness activities in hospitals nationwide, reaching hundreds of HCPs and patients.
- VigiTest Competition 2025: Recognized top performers; included a Q&A section on pharmacovigilance concepts.
7. EPVC Tips & Public Engagement
- Encourages the public to:
- Discuss side effects with HCPs.
- Read patient leaflets.
- Report ADRs via:
- Email:
pv.followup@edaegypt.gov.eg - Hotline: 15301
- Online reporting portal.
- Email:
- Emphasizes that every report matters for global drug safety.
8. Contact & Survey
- EPVC Contact Details: Address, hotline, fax, email, and reporting link provided.
- Survey Link: Invites feedback to improve EPVC communication.
