Drug regulator to issue warning against Pholcodine in cough syrups
The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.
The European Medicines Agency has completed its investigation into the safety of nomegestrol and chlormadinone, and has started reviewing risks linked to the cough suppressant, pholcodine, and the epilepsy and migraine drug, topiramate.
The European Medicines Agency (EMA) has started a review of medicines that contain pholcodine following concerns that their use may put people at risk of developing anaphylactic reactions (a sudden, severe and life-threatening allergic reaction) to certain medicines called neuromuscular blocking agents (NMBA). Pholcodine is used to treat non-productive (dry) cough in adults and children and NMBAs are used in general anaesthesia to prevent spontaneous muscle movements to improve operating conditions.
Since 2009, pholcodine, used as an active ingredient in cough syrups, has been the subject of discussions on its potential risk of cross allergy with muscle relaxants such as curare. Indeed, cases of allergic reactions to curares after the use of pholcodine, rare but serious (anaphylactic shock), have been reported.