This newsletter, issued by the Egyptian Pharmaceutical Vigilance Center (EPVC) under the Egyptian Drug Authority (EDA), provides updates on drug safety monitoring and related activities in Egypt.
1. Key Safety Investigations
- Potential Signal: Tirzepatide and Gastroparesis
- Issue: The EPVC is investigating a potential link between the diabetes/weight-loss drug Tirzepatide and impaired gastric emptying (gastroparesis).
- Evidence: The investigation was triggered by a serious domestic case and supported by an analysis of 389 global cases from the WHO database (VigiBase). A plausible biological mechanism exists, as delayed gastric emptying is a known effect of this drug class (GLP-1 receptor agonists).
- Conclusion: The EPVC has classified this as a potential risk, meaning it requires continued monitoring.
- Local Case Report: Glyceryl Trinitrate (Nitroglycerin) Overdose
- Incident: A case is reported where a 75-year-old male patient experienced a dangerous drop in blood pressure and shock after receiving an inappropriate initial dose of intravenous glyceryl trinitrate for a hypertensive emergency.
- Recommendation: The newsletter strongly reminds healthcare professionals to strictly adhere to the recommended dosing protocol: start with a low dose (5 mcg/min) and titrate upward slowly, with close monitoring.
2. EPVC News & Initiatives
- “Together for Safe Medicine” Initiative: The EDA participated in a pharmacovigilance awareness event at Tanta University, educating 60 healthcare professionals on the importance of reporting Adverse Drug Reactions (ADRs).
- VigiTest Competition: A new, bi-monthly competition was launched to test and enhance the pharmacovigilance knowledge of healthcare professionals, with monthly and annual winners.
- Vigiflow Expansion: The EPVC acknowledged and thanked several health directorates and oncology centers for their successful efforts in expanding the national adverse event reporting system (Vigiflow).
- “Fight the Fakes” Campaign: The EDA participated in the global week against substandard and falsified (SF) medicines, conducting awareness activities for university students and the public.
3. EPVC Tip
A core reminder for healthcare professionals: “Always ensure accurate and timely documentation” when reporting any drug-related issue, as this is crucial for patient safety.
