Drug Safety Newsletter – Edition 108 – 10 August 2022
10/08/2022
Medicines for human use
Safety update
The latest edition of the HPRA Drug Safety Newsletter (edition 108) includes important updates to support the safe and appropriate use of the following medicines:
Topiramate - commencement of EU review regarding potential risk of neurodevelopmental disorders in children exposed in utero
Mavenclad (cladribine) - new liver monitoring requirements to minimise risk of serious liver injury
Pregabalin - expanded warning regarding drug dependence and withdrawal symptoms
Product information updates recommended by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC)