This issue from the Egyptian Pharmaceutical Vigilance Center (EPVC) focuses on important drug safety updates, including a European review of a risk associated with a vaccine, a detailed local case report of a serious adverse reaction, updates on EPVC activities, and key tips on vaccine safety.
Key Sections Summarized
1. Safety Notification: Risk of Encephalitis with Varicella Vaccines
- Issue: The European Medicines Agency’s PRAC is reviewing the known risk of encephalitis (brain inflammation) following varicella (chickenpox) vaccination. This was prompted by a report of a fatal case in Poland.
- Current Status: Encephalitis is already listed as a rare side effect in the vaccine’s product information. The review aims to reassess all available evidence to determine if further regulatory action is needed.
- Recommendation: Vaccines can continue to be used as per approved guidelines while the investigation is ongoing. Healthcare professionals should be aware of symptoms like confusion, seizures, sensitivity to light, and nausea/vomiting.
2. Local Case Report: Fournier’s Gangrene Linked to Empagliflozin
- Case: A serious adverse reaction was reported for a 68-year-old male with multiple health issues (diabetes, kidney disease, heart disease). He developed Fournier’s gangrene, a rare, life-threatening bacterial infection of the genital area, shortly after starting Empagliflozin (an SGLT2 inhibitor for diabetes).
- Background: Fournier’s gangrene is a known but rare risk associated with SGLT2 inhibitors like Empagliflozin, as mentioned in the drug’s safety information.
- Recommendations:
- For Patients: Maintain strict hygiene, be aware of early symptoms (pain, swelling, redness in genital area), and seek immediate medical help if they occur.
- For Healthcare Professionals: Use caution when prescribing to high-risk patients (with diabetes, obesity, kidney issues), monitor patients closely after starting treatment, and discontinue the drug immediately if Fournier’s gangrene is suspected.
3. EPVC News
- Appreciation: The EPVC acknowledged the Port Said Governorate for its outstanding efforts in promoting pharmacovigilance through awareness campaigns and patient education.
- New Initiative: The EPVC announced the start of the 7th wave of its “Together for Safe Medicine” initiative, beginning with an online introductory lecture on July 17, 2025.
4. EPVC Tips: Understanding Vaccinovigilance
- This section emphasizes the importance of monitoring vaccine safety (Vaccinovigilance) after public use.
- Key Advice:
- Get vaccinated at authorized centers.
- Report any unusual symptoms after vaccination.
- Stay for observation after receiving a shot.
- Keep a vaccination record.
- Rely on trusted sources like the WHO, Ministry of Health, or EDA for information.
