Stop the sale in Europe of drugs which contain pholcodine, used in adults and children for the treatment of dry cough and, in combination with other active substances, against cold and flu symptoms. This was communicated by the Ema drug agency, explaining that its Pharmacovigilance Committee (Prac) – in the last meeting which was held from November 28 to December 1 – concluded the review of medicines with pholcodine, recommending “the withdrawal of EU marketing authorisations” for these products which therefore “will no longer be available by prescription or over the counter”.
During the review – reports the EU regulatory body – the Prac evaluated all available information, including the final results of the Alpho study, post-marketing safety data and notifications from third parties, such as those from healthcare professionals. Taken together, they showed that the use of pholcodine in the 12 months prior to general anesthesia with neuromuscular blocking agents (Nmbas) is a risk factor for developing a sudden allergic reaction to the Nmba, serious and life-threatening. As it has not been possible to identify effective measures to minimize this risk, nor to identify a patient population for which pholcodine’s benefits outweigh its risks, pholcodine-containing medicines have been withdrawn from the EU market and will therefore no longer be available. available.
Healthcare professionals are therefore urged to reevaluate their patients, consider treatment alternatives and advise clients to stop using medicines containing pholcodine. In the event of anesthesia that requires the administration of Nmba – specifies the EMA – healthcare professionals must check whether patients have used medicines containing pholcodine in the last 12 months and, if they have done so, be aware of potential anaphylactic reactions to Nnba.
