This document communicates safety updates for two different products based on reviewed safety signals.
1. Sertraline
Safety Signal: Multiple acyl-coenzyme A dehydrogenase deficiency (MADD)-like disorder (EPITT no 20125)
Updates:
- Summary of Product Characteristics (SmPC) – Section 4.8 (Undesirable Effects):
- Multiple acyl-coenzyme A dehydrogenase deficiency (MADD)-like disorder has been added as an adverse reaction with a frequency of “Not known”.
- Package Leaflet – Section 4 (Possible Side Effects):
- Patients are informed of a side effect with frequency “Not known”:
- Muscle weakness and severe muscle pain, which can be a sign of a MADD-like disorder.
- Patients are informed of a side effect with frequency “Not known”:
2. Sulfamethoxazole, Trimethoprim (Cotrimoxazole)
Safety Signal: Circulatory shock (EPITT no 20135)
Updates:
- Summary of Product Characteristics (SmPC) – Section 4.8 (Undesirable Effects):
- Circulatory shock has been added as an adverse reaction with a frequency of “Not known” under Vascular disorders.
- A description notes that cases of circulatory shock, often accompanied by fever and not responding to standard hypersensitivity treatment, have been reported, mainly in immunocompromised patients.
- Package Leaflet – Section 4 (Possible Side Effects):
- Under “Serious side effects,” patients are advised to call the emergency department immediately if they experience multiple symptoms such as fever, very low blood pressure, or increased heart rate, as it may be a sign of shock.
Purpose
These updates inform healthcare professionals and patients of newly recognized, rare but serious risks associated with these medicines, ensuring they are clearly communicated in the official product information to aid in monitoring and prompt identification.
