The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has confirmed that the benefits of pholcodine-containing cough medicines outweigh their risks and that these medicines should remain available for the treatment of non-productive (dry) cough in children and adults. Patients taking pholcodine-containing medicines can continue to do so, and should contact their doctor or pharmacist if they have any questions.

The review was initiated because of concerns that there could be cross-sensitisation between pholcodine and neuromuscular blocking agents (NMBAs), which in turn could lead to anaphylactic reactions in some patients receiving NMBAs during emergency surgery who had previously taken pholcodine. These concerns were raised by a study that indicated that the reduction of pholcodine consumption following its withdrawal from the market in Sweden and Norway was associated with a decrease of reports of anaphylactic reactions to NMBAs in these two countries.

Following a review of data on the safety and efficacy of these preparations, the Committee found no firm evidence to substantiate the hypothesis of cross-sensitisation and subsequent increased risk of anaphylactic reactions during surgery. It also noted that pholcodine-containing medicines have been available for the treatment of non-productive cough in the EU for decades and existing data confirm a positive benefit-risk balance of these medicines. The Committee was therefore of the opinion that the marketing authorisations of pholcodine should be maintained in all EU Member States where it is currently authorised and that no further regulatory action is necessary.