In Germany, the active ingredient pholcodine has not been approved since February 2001, as explained by the Federal Institute for Medicines and Medical Devices (BfArM).
According to the institute, pholcodine is “an opioid that has been used to treat non-productive (dry) coughs in children and adults.” It acts directly in the brain and suppresses the cough reflex by reducing nerve impulses to the muscles involved in coughing. Appropriate formulations have also been used in combination with other active ingredients to treat cold and flu symptoms.
Risk of life-threatening allergic reactions
The recommendation to no longer allow such agents in the EU was made following review by the EMA Drug Safety Committee (PRAC). According to the information, experts have concluded that pholcodine-containing products may increase the risk of severe and life-threatening allergic reactions to drugs used to treat neuromuscular blockades.
The EMA recommendation is based, among other things, on a study conducted in France, according to which the use of pholcodine up to twelve months before general anesthesia may increase the risk of such a reaction.