Drug Safety Newsletter – Edition 110 – 21 December 2022
21/12/2022
Medicines for human use
Safety update
The latest edition of the HPRA Drug Safety Newsletter (edition 110) includes important updates to support the safe and appropriate use of the following medicines:
Janus Kinase inhibitors (JAKi) - Recommendations to mitigate the risks of malignancy, major adverse cardiovascular events, serious infections, VTE and mortality when used to treat chronic inflammatory disorders
Gabapentin - Expanded warnings around abuse potential, dependence and withdrawal.
Amoxicillin - Drug-induced enterocolitis syndrome (DIES)
Product information updates recommended by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC)