This issue from the Egyptian Pharmaceutical Vigilance Center (EPVC) presents a new vaccine safety alert concerning a rare neurological risk, a detailed local case report of a serious adverse reaction to a common medication, and updates on the center’s educational and collaborative activities.
Key Sections Summarized
1. Safety Alert: RSV Vaccines & Risk of Guillain-Barré Syndrome (GBS)
- Issue: UK regulatory authorities have identified a small increased risk of Guillain-Barré Syndrome (GBS), a rare neurological disorder, in adults aged 60 years and older following vaccination against Respiratory Syncytial Virus (RSV).
- Risk Level: The risk remains very rare, with estimates ranging from approximately 7 to 25 excess cases per million doses administered.
- Key Advice: The benefits of RSV vaccination still outweigh this small risk. Healthcare professionals are advised to:
- Inform patients in this age group to be alert for symptoms of GBS (such as muscle weakness or paralysis).
- Encourage seeking immediate medical attention if symptoms occur.
- Note that no increased risk has been found in pregnant women receiving the vaccine.
2. Local Case Report: Mesenteric Vascular Occlusion from Oral Contraceptives
- Case: A serious adverse reaction was reported for a 33-year-old female who developed a life-threatening mesenteric vascular occlusion (a blood clot in the intestinal blood vessels) after one year of using a combined oral contraceptive (Ethinylestradiol-Gestodene). This required surgical resection of the small intestine.
- Background: While Combined Oral Contraceptives (COCs) are known to carry a risk of venous thromboembolism, thrombosis in mesenteric vessels is extremely rare.
- Recommendations:
- Healthcare professionals should consider this rare possibility in women taking COCs who present with sudden, severe abdominal pain.
- COCs should be prescribed under appropriate medical supervision, considering the patient’s individual risk factors for blood clots.
3. EPVC News
- Scientific Collaboration: The EPVC participated in a pharmacovigilance scientific event at the Saudi German Hospital in Alexandria, engaging with university professors, students, and healthcare professionals to promote drug safety awareness.
- “Together for Safe Medicine” Initiative: Wave 7 of the initiative was launched, featuring online training for over 60 pharmacists on the basics of adverse drug reaction reporting.
- VigiTest Competition: The newsletter announces the continuation of this monthly competition to test and enhance pharmacovigilance knowledge among healthcare professionals, with awards for top participants.
4. EPVC Tips: Medications and Vaccinations
- This section advises patients to always inform their healthcare provider about all medications and supplements they are taking before getting vaccinated.
- Key reasons: Some drugs, especially those that suppress the immune system (e.g., chemotherapy, high-dose steroids), can affect a vaccine’s effectiveness or safety. The provider can then advise on the best timing and type of vaccine.
