Drug Safety Newsletter – Edition 115 – 26 April 2024
26/04/2024
Medicines for human use
Safety update
The latest edition of the HPRA Drug Safety Newsletter (edition 115) includes important updates to support the safe and appropriate use of the following medicines:
Valproate (Epilim): New precautionary measures regarding the potential risk of neurodevelopmental disorders in children of fathers treated with valproate in the three months before conception
NSAIDs: Updated recommendations on the use of non-steroidal anti-inflammatory drugs (NSAIDs) during pregnancy
Cystic Fibrosis transmembrane conductance regulators (CFTRs): New warning on the risk of depression and related events associated with Kalydeco, Orkambi, Symkevi and Kaftrio
Product information updates recommended by the EMA’s Pharmacovigilance Risk assessment Committee (PRAC)