This newsletter from the EPVC, part of the Egyptian Drug Authority, focuses on drug safety alerts, a local case report, center news, and pharmacovigilance tips. Its mission is to monitor and ensure the safety of pharmaceutical products in Egypt.
Key Sections Summarized
1. Safety Notification: Severe Itching After Stopping Cetirizine/Levocetirizine
- Issue: The US FDA warns that patients stopping long-term daily use of allergy medicines containing cetirizine or levocetirizine may experience rare but severe itching (pruritus).
- Action: Prescribing information and OTC labels will be updated with a new warning.
- Recommendations:
- Patients: Contact a healthcare professional if severe itching occurs after stopping the medication.
- Healthcare Professionals: Discuss this risk with patients, especially for chronic use.
2. Safety Reminder: Rabies Vaccination
- Importance: Rabies is a fatal disease preventable through pre- and post-exposure vaccination.
- Adverse Events: While generally safe, vaccines can cause reactions.
- Common (Mild): Pain at injection site, fever, headache.
- Rare (Severe): Anaphylaxis, neurological events like Guillain-Barré Syndrome.
- Recommendations: Observe patients for 30 minutes post-vaccination, adhere to schedules, maintain the cold chain, and report any adverse events.
3. Local Case Report: Paracetamol-Induced Hepatotoxicity
- Case: A 46-year-old male developed serious liver damage (jaundice, highly elevated enzymes) after taking 4-5 grams of paracetamol daily for four months for joint pain.
- Key Information:
- Mechanism: Liver injury is caused by a toxic metabolite (NAPQI), especially in overdoses.
- Risk Factors: High daily dose (>4g in adults), chronic use, use of multiple paracetamol-containing products, alcohol use, and certain health conditions.
- Treatment: Early administration of N-acetylcysteine (NAC) is critical.
- Recommendations: Adhere to recommended dosages, avoid multiple paracetamol products, and use with caution in patients with liver issues.
4. EPVC News: VigiFlow Expansion Project
- The EPVC is expanding its national pharmacovigilance database, VigiFlow.
- Actions Taken: Training programs and workshops were conducted for healthcare providers (pharmacists, nurses) in various health directorates and chest disease centers to improve adverse drug reaction reporting.
- Recognition: Several health directorates (Giza, Cairo, Menofia) and the Nasser Institute were recognized for their high reporting rates in May.
5. EPVC Tips: Restriction of Injection in Inflamed Tissue
- Injecting into inflamed tissue should be avoided due to:
- Poor drug absorption.
- Risk of tissue damage and spread of infection.
- Increased pain and unreliable drug action.
- Recommendation: Always inject into healthy, non-inflamed sites.
