EU authority warns against cough medicine

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The European Medicines Agency warns against medicines for the treatment of dry cough that contain the active ingredient pholcodine. Here’s why.

The European Medicines Agency (Ema) is recommending that the EU approval for cough medicines containing pholcodine be revoked. This active ingredient has not been approved in Germany since February 2001, according to the Federal Institute for Drugs and Medical Devices (BfArM).

This is the active ingredient in question
According to the institute, pholcodine is “an opioid that has been used to treat nonproductive (dry) cough in children and adults.” It acts directly in the brain to suppress the cough reflex by reducing nerve signals to the muscles involved, it said. Corresponding drugs had also been used in combination with other agents to treat cold and flu symptoms.

What’s problematic about pholcodine
The recommendation that such drugs no longer be approved in the EU followed a review by Ema’s Committee on the Safety of Medicines (PRAC). The experts reportedly concluded that pholcodine-containing products could increase the risk of severe and life-threatening allergic reactions to neuromuscular blockade drugs.

The Ema recommendation is based, among other things, on a study conducted in France showing that taking pholcodine up to 12 months before general anesthesia may increase the risk of such an allergic reaction.