HPRA Drug Safety Newsletter Edition 108

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 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)

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