Tuesday, April 23, 2024

Cough medicine products banned

Approval for pholcodine – a medicine found in some cough syrups and lozenges – to be sold in New Zealand will be withdrawn on 12 January 2024, the Ministry of Health announced today.

It says the decision was made on safety grounds, as there is a small risk that taking pholcodine may make patients more susceptible to anaphylaxis (a rare but life-threatening allergic reaction) during surgery.

“Specifically, patients who require surgery involving neuromuscular blocking agents (NMBAs) may be more likely to experience anaphylaxis if they have taken pholcodine within the last 12 months,” the Ministry said.

The change will align New Zealand with several other countries, including Australia and the UK, where pholcodine has also been withdrawn.

“If you have any of the affected products at home, you don’t have to do anything. This is not a recall, so you don’t have to return any products,” the Ministry said.

“If you’re scheduled for a surgery and you’re concerned, talk to your anaesthetist. Not all surgeries use NMBAs, and your anaesthetist will be able to answer any questions you may have relating to the risk.”

The decision follows a review by Medsafe of the safety and efficacy of pholcodine.

“While the review suggested that the risk of anaphylaxis is very small, it noted that it is a serious and life-threatening event, and there are no existing measures that can mitigate the risk.”

Pholcodine has been classified as a pharmacist-only medicine since December 2022 following earlier evidence suggesting a safety issue.

Products affected:

  • Difflam Plus Dry Cough + Antibacterial + Anti-inflammatory Lozenge, Blackcurrant Flavour Sugar Free;
  • Duro-Tuss Cough Liquid Expectorant Oral solution, 0.8mg/1mg per mL;
  • Duro-Tuss Dry Cough Lozenge, Lemon and Orange flavours;
  • Duro-Tuss Dry Cough Liquid Forte Oral solution, 3 mg/mL;
  • Duro-Tuss Phenylephrine PE Dry Cough + Nasal Decongestant Oral solution;
  • Duro-Tuss Dry Cough Liquid Regular Oral solution, 1 mg/mL, New Formula;
  • Duro-Tuss Dry Cough Liquid Junior Oral solution, 1 mg/mL, New Formula (not currently being sold in NZ);
  • Difflam Plus Cough Sore Throat Lozenges Lozenge, Sugar Free Honey, Lemon & Ginger, Pineapple & Lime flavours (not currently being sold in NZ);
  • Pholcodine Linctus BP Linctus, 5 mg/5mL, (AFT);
  • Strong Pholcodine Linctus BP Linctus, 10 mg/5mL, Pinewood;
  • Stubborn Dry Tickly Cough (Pharmacy Health) Linctus, 2 mg/mL (not currently being sold in NZ)..

For more information see the Medsafe website.

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