What you need to know about the pholcodine product recall

What you need to know about the pholcodine product recall

The health ministry issued a recall last month for all medicines containing this cough suppressant over fears of rare but life-threatening side effects.

Last month, the Drug Control Authority issued a product recall for pholcodine, which is used for the treatment of dry cough.

Indicated as a cough suppressant, pholcodine is an opioid-type medicine prescribed for adults and children aged two and above for the treatment of non-productive (dry) cough. It is sometimes used in combination with other active substances to treat symptoms of cold and flu.

In Malaysia, pholcodine is classified as a Group C item, which means it can only be sold as a dispensed medicine with an entry in the prescription book by a community pharmacist.

Following a thorough investigation by the National Pharmaceutical Regulatory Agency (NPRA), concurrent pholcodine medication withdrawals in the United Kingdom and Australia, and a recommendation for withdrawal by the European Regulatory Agency, the registration of all pholcodine-containing products in Malaysia has been cancelled, with all available preparations off the market as of March 20.

The NPRA’s decision is linked to a recently concluded French clinical study that demonstrated possible association between pholcodine and very rare but serious anaphylactic reactions to neuromuscular blocking agents used as general anaesthesia in medical surgeries, if used together in the past 12 months.

In other words, those who took pholcodine in the last year are at a higher risk of severe allergic reactions if they’re given that particular type of anaesthesia during surgeries.

As the NPRA has found the risk of pholcodine use to outweigh its benefits, it has temporarily quarantined and withheld any and all pholcodine product preparations.

To date, 12 cases with 17 adverse events – diarrhoea, rashes/urticaria, and breathing difficulties – linked to pholcodine-containing products have been reported to the NPRA, with no local cases of anaphylactic reactions yet.

Recalled products containing pholcodine. (Ministry of Health pic)

So, what can you take?

If you have a dry cough, dextromethorphan is a good alternative. Medicines including dextromethorphan include Hosolvan DM Elixir, Sedilix DM Linctus, and Tussidex Forte Linctus. For more information, consult your pharmacist or doctor.

What if you were recently prescribed pholcodine?

Those who have had recent pholcodine exposure and are undergoing surgery soon should inform their doctor before the procedure, especially if they took pholcodine in the past 12 months.

Even if you don’t think you’re going to have surgery soon, you should stop taking pholcodine-containing medicines immediately and consult your pharmacist or physician for alternatives.

Leftover pholcodine at home should be returned to your nearest pharmacy or doctor so necessary actions can be taken, and for safe disposal.

Finally, the health ministry encourages everyone to report to the NPRA any suspected adverse effects after taking pholcodine. You can do so by clicking here.

This article was written by DOC2US, a mobile application that allows you to talk to a doctor or any healthcare professionals via text chat at any time and from anywhere.

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