HPRA Drug Safety Newsletter Edition 115

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The latest edition of the HPRA newsletter 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)


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