Here's why the TGA has recalled 55 cough medicine products from Australian pharmacies

Multiple cough medicine products have been recalled over an increased risk of a sudden, severe and life-threatening allergic reaction.

Patients are being advised to stop containing the 55 recalled cough and flu medicine products that are sold in pharmacies over the counter. Source: Supplied Source: AAP / Flavio Brancaleone

Key Points

• Over-the-counter cough and flu medicines have been recalled due to safety concerns.
• The Therapeutic Goods Administration says 55 products are affected by the recall.
• Patients are being advised to consider safer alternatives to treat a dry cough.

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.

Retailers are being urged to remove the product from shelves and to contact the wholesaler for a refund.

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.

The list of recalled products includes cough syrup brands like the Pharmacy Action Dry Cough Relief and the Siolvon Pholcodine Dry Forte.

What is the safety concern?

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

The TGA recall notice said the review by the European Medicines Agency's safety committee found a risk associated with the reaction from the combined use of the recalled items with flu medicine.

There is also concern, about the combined reaction with medicine used during general anaesthesia.

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

What advice is being given to consumers and patients?

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."

The list of recalled products include:

1. Amcal dry cough oral liquid bottle
2. Apohealth dry tickly cough relief oral liquid bottle (1-4mg/mL of pholcodine)
3. Benadryl dry, tickly cough forte oral liquid bottle (4mg/mL of pholcodine)
4. Blooms The Chemist dry cough relief and nasal decongestant oral liquid bottle
5. Chemists' Own dry cough range of products oral liquid bottle (1-4mg/mL of pholcodine)
6. Duro-Tuss dry cough and lozenge products
7. Difflam plus dry cough lozenges
8. Pharmacy Choice dry cough relief oral liquid bottle (5mg/mL of pholcodine)
9. Priceline Pharmacy dry cough relief oral liquid bottle
10. Soul Pattinson dry tickly cough medicine oral liquid bottle
11. TerryWhite Chemmart dry cough relief oral liquid bottle (4mg/mL of pholcodine)