The European Medicines Agency (EMA) warns against drugs for the treatment of dry cough that contain the active ingredient pholcodine. In a message distributed on Friday, the authority recommended revoking the EU approval for it. In Germany, the active ingredient pholcodine has not been approved since February 2001, as the Federal Institute for Drugs and Medical Devices (BfArM) explained.
According to the institute, pholcodine is “an opioid that has been used to treat nonproductive (dry) cough in children and adults.” It works directly in the brain and suppresses the cough reflex by reducing nerve signals to the muscles involved in coughing. Corresponding drugs have also been used in combination with other active ingredients to treat cold and flu symptoms.
The recommendation to no longer approve such agents in the EU was made after an examination by the EMA Committee for Drug Safety (PRAC). According to the information, the experts came to the conclusion that pholcodine-containing agents could increase the risk of severe and life-threatening allergic reactions to drugs against neuromuscular blockades. The EMA recommendation is based, among other things, on a study conducted in France, according to which taking pholcodine up to twelve months before general anesthesia can increase the risk of such a reaction.
