This newsletter from the Egyptian Pharmaceutical Vigilance Center (EPVC) focuses on a critical Direct Healthcare Professional Communication (DHPC), a local case report, and updates on national pharmacovigilance activities.
1. Critical Safety Update: Thiocolchicoside (DHPC)
- Issue: Important new restrictions for systemic thiocolchicoside (a muscle relaxant) due to a risk of genotoxicity (damage to genetic material that can cause cancer or birth defects).
- New Contraindications:
- Men: Must use effective contraception during treatment and for 3 months after stopping.
- Women of Childbearing Age: Must use effective contraception during treatment and for 1 month after stopping.
- Reason: Preclinical studies show a metabolite of the drug can cause cell damage (aneuploidy) at doses close to those used in humans. This poses a potential risk to a fetus if conceived during or shortly after treatment.
- Reminder: The drug should only be used short-term for acute spinal disorders in adults and adolescents (16+), with strict limits on dose and duration (max 7 days orally, 5 days intramuscularly).
2. Local Case Report: Terbutaline and Hyperglycemia
- Incident: A case was reported of a 50-year-old diabetic male who developed severe hyperglycemia (blood glucose: 400 mg/dl) requiring hospitalization after taking terbutaline sulfate (a bronchodilator) for 15 days.
- Mechanism: Terbutaline, as a beta-2 agonist, is known to increase blood glucose levels.
- Recommendation: Healthcare professionals are reminded to use terbutaline with caution in diabetic patients and to monitor blood glucose levels closely, as it can worsen pre-existing diabetes.
3. EPVC News & Initiatives
- Vigiflow Expansion: The EPVC thanked the Ministry of Health and Population (MoHP) and the Egyptian Health Care Authority (EHA) for their high quantity and quality of adverse drug reaction reports submitted to the national Vigiflow database.
- “Together for Safe Medicine” Initiative Results: The top 10 pharmacists from the initiative’s fifth and sixth waves were recognized for their exceptional work in promoting pharmacovigilance and submitting adverse reaction reports.
- VigiTest Competition: The pharmacovigilance knowledge competition continues, encouraging healthcare professionals to participate via a provided link or QR code.
4. EPVC Tip: Risk-Benefit Balance
The newsletter emphasizes the core principle of pharmacovigilance: continuously monitoring a drug’s risk-benefit balance to ensure its benefits outweigh its risks for patients throughout its lifecycle.
