Drug Safety Newsletter – Edition 109 – 10 November 2022
10/11/2022
Medicines for human use
Safety update
The latest edition of the HPRA Drug Safety Newsletter (edition 109) includes important updates to support the safe and appropriate use of the following medicines:
Nurofen Plus (codeine/ibuprofen) - serious clinical harms, including renal tubular acidosis and severe hypokalaemia, following prolonged use of codeine/ibuprofen at higher than recommended doses
Leuprorelin-containing depot medicines - risk of idiopathic intracranial hypertension (pseudotumor cerebri)
Pholcodine-containing medicines - review of risk of developing anaphylactic reactions to neuromuscular blocking agents (NMBA)
Product information updates recommended by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC)