Cough syrups, lozenges recalled due to safety risk

February 27, 2023 11:22 PM PST | By AAPNEWS
 Cough syrups, lozenges recalled due to safety risk
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Cough medicines containing pholcodine are being recalled from Australian pharmacies due to safety concerns.

The Therapeutic Goods Administration on Tuesday cancelled the 55 products from the Australian Register of Therapeutic Goods and ordered the recall.

It's due to an increased risk of anaphylactic reaction when pholcodine-containing products are combined with medicines used during general anaesthesia.

Pholcodine is used in a wide range of over-the-counter products, including syrups and lozenges, to treat dry cough. 

It is also used in products that treat cold and flu symptoms.

"It is difficult to reliably predict who may be at risk of anaphylaxis during anaesthesia and some patients may not know if they have taken pholcodine medicines recently," TGA head John Skerritt said in a statement.

"In addition, while surgical facilities may ask about which prescription medicines a patient is taking, they may not ask about over the counter products."

The TGA began investigating the medicines after the European Medicines Agency recommended withdrawing the products' European marketing authorisations.

The TGA has so far received 50 reports of Australian cases of suspected pholcodine-related anaphylactic reactions, including one death.

Consumers should ask their doctor or pharmacist for advice on safer alternatives to treat a dry cough, Professor Skerritt said.

"If you will need general anaesthesia and have taken pholcodine in the past 12 months, I advise you to tell your health professional," he said.

"Health professionals should also check whether patients scheduled to undergo general anaesthesia have used pholcodine in the previous 12 months."


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