TGA blocks key dry cough medicine ingredient

The medicines regulator has banned and ordered a recall of products containing pholcodine. It is a common ingredient in cough drops and syrups.

Pholcodine is an ingredient in 55 products and has been linked to severe anaphylactic reactions. Picture: istock

The federal medicines regulator on Tuesday banned and ordered a recall on products containing pholcodine, a common ingredient in cough medicines.

The Therapeutic Goods Administration said a safety investigation had found a link between medicines that contained pholcodine, and an increased risk of anaphylactic allergic reactions to certain medicines used as muscle relaxants during general anaesthesia.

Pholcodine is common in cough drops and ­syrups including over-the-­counter medicines such as Benadryl Dry Tickly Cough and Duro-Tuss Dry Cough Liquid Regular.

Some 55 products containing pholcodine have been struck off the Australian register of therapeutic goods and ordered to be recalled from pharmacy shelves.

The TGA said it had received, as recently as February 9, 50 reports of suspected pholcodine-related anaphylactic reactions during general anaesthesia, including one fatality.

It comes after the European Medicines Agency in December last year recommended withdrawal of the products.

The move has been welcomed by experts.

“I strongly endorse the TGA’s decision to deregister pholcodine,” Flinders University senior research fellow Ashley Hopkins said. “Pholcodine is a cough suppressant that has been associated with severe allergic reactions that can be life-threatening.

“These reactions can occur even in patients who have no ­history of allergy to any other medication.”

University of Adelaide senior lecturer Ian Musgrave said pholcodine had “little or no pain ­relieving effect”.

“Since pholcodine was voluntarily withdrawn in Norway, there was a reduction in neuromuscular blocking agent anaphylaxis cases over the following three years, supporting the case for withdrawal.”