HPRA Drug Safety Newsletter Edition 110

Download: hpra-drug-safety-newsletter-edition-110.pdf 280 KB

 The latest edition of the HPRA Drug Safety Newsletter (DSN 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)



« Back