Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November – 1 December 2022

EMA recommends withdrawal of pholcodine medicines from EU market

EMA’s safety committee, PRAC, has concluded its review of medicines containing pholcodine, which are used in adults and children to treat non-productive (dry) cough and, in combination with other active substances, for the treatment of symptoms of cold and flu, and has recommended the revocation of the EU marketing authorisations for these medicines.

During the review, the PRAC evaluated all available evidence including the final results of the ALPHO study,1 post-marketing safety data and information submitted by third parties such as healthcare professionals. The available data showed that use of pholcodine in the 12 months before general anaesthesia with neuromuscular blocking agents (NMBA) is a risk factor for developing an anaphylactic reaction (a sudden, severe and life-threatening allergic reaction) to NMBAs…