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MOH Recalls Cough Meds With Pholcodine After 17 Reports Of Adverse Effects In M'sia

Pholcodine is commonly found in cough medications and lozenges.

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The Ministry of Health (MOH) has issued a notice to recall and ban the distribution of products containing pholcodine, an opioid substance that is commonly found in cough medications and lozenges

In a statement posted on Twitter today, 23 March, Health director-general Tan Sri Dr Noor Hisham Abdullah said products containing pholcodine have been found to pose safety risks for users, even 12 months after consumption.

"There is a risk of anaphylaxis (severe and potentially life-threatening allergic reaction) with the use of muscle-relaxant or neuromuscular blocking agents (NMBAs) during the general anaesthesia process, especially to those who have taken medicines containing pholcodine in the past 12 months," he explained.

"In other words, those who have taken a medicine containing pholcodine (usually a cough medicine) in the past 12 months face a higher risk of experiencing anaphylaxis if they are given muscle relaxants or NMBAs during the full anaesthesia process, for example, during surgery," he added.

Bernama reported that pholcodine is a medicine to treat dry cough (nonproductive/dry, irritating) in adults and children.

A product containing pholcodine.

Image via Utusan Malaysia

As of now, the National Drug Adverse Effects Monitoring Centre under the National Pharmaceutical Regulatory Agency (NPRA) has received 12 reports of 17 adverse effects following the use of pholcodine

Of the cases, none of them developed anaphylaxis.

Meanwhile, the World Health Organization (WHO) reported 852 cases of adverse effects after patients had taken pholcodine.

Among the cases, 42 were reports of anaphylactic reactions and 20 were reports of anaphylactic shocks.

The UK, Australia, France, and Norway have also taken regulatory action to cancel and recall products that contain pholcodine, said Noor Hisham.

Health Minister Dr Zaliha Mustafa said people who are currently taking cough medication with pholcodine should stop consuming it immediately and consult a doctor for an alternative treatment

She also advised those who are currently taking any cough medication to check the product label to see if it contains pholcodine, reported The Star.

Pharmacies and clinics are advised to stop prescribing pholcodine to customers.

Based on the statement today, MOH has also agreed to cancel the registration of products containing the risky substance.

Below are 14 products that are found to contain pholcodine:

1. Duro-Tuss Regular Cough Liquid 1mg/ml
2. Duro-Tuss Forte Cough Liquid 3mg/ml
3. Duro-Tuss Expectorant Cough Liquid
4. Difflam Anti-Inflammatory Anti-Bacterial Lozenges With Cough Suppressant
5. Russedyl Compound Linctus
6. Promedyl Plus Linctus
7. Pholcodyl Syrup
8. Pholcodyl Forte Syrup
9, Rhynacol F Syrup
10. Ducodin Forte Linctus15mg/5ml
11. Ducodin Linctus 6mg/6ml
12. Tussedyl Forte Syrup 16mg/6ml
13. Axcel Iridin Linctus
14. Axcel Iridin Plus Linctus

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