EMA Recommends Pulling Pholcodine Cough Meds

The European Medicines Agency (EMA)’s safety committee has recommended withdrawing medications containing pholcodine, an opioid active ingredient used alone or in combination with other substances, to treat dry cough, cold and flu symptoms.

At its latest monthly meeting, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) said that pholcodine use 12 months prior to receiving general anesthesia with a neuromuscular blocking agent (NMBA) is a risk factor for developing a severe and life-threatening allergic reaction to NMBAs.

“As it was not possible to identify effective measures to minimize this risk, nor to identify a patient population for whom the benefits of pholcodine outweigh its risks, pholcodine-containing medicines are being withdrawn from the EU market and will therefore no longer be available by prescription or over-the-counter,” PRAC said.

Used as a cough suppressant since the 1950s, pholcodine-containing drugs are available in syrups, oral solutions and capsules, and are marketed under a variety of branded and generic names in the EU including Dimetane, Biocalyptol and Broncalene.