THE Ministry of Health (MOH) has issued cancellation and recall of all registered products containing pholcodine.

Health director-general Dr Noor Hisham Abdullah said the Drug Control Authority (DCA) found that products containing pholcodine have been found to pose safety risks for users.

“There is a risk of anaphylaxis 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.

“In other words, those who have taken a medicine containing pholcodine (usually a cough medicine) in the past year 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 said in a statement today.

Pholcodine is a medicine to treat dry cough in adults and children.

Noor Hisham said in Malaysia, the substance is classified as a Group C controlled drug and can be obtained without a prescription and there are 14 products containing pholcodine registered with DCA in a single form and combination with other drugs.

He said that so far, 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 but no reports of anaphylaxis have been received.

He said DCA’s decision to cancel the registration and recall of products containing pholcodine was based on evidence from various parties, including the “Allergy to Neuromuscular Blocking Agents and Pholcodine Exposure” study.

“Agencies of other countries such as the UK, Australia, France and Norway have also taken regulatory action for the cancellation and recall,” he said.

He said the World Health Organization (WHO) also reported 852 reports of adverse effects involving the use of pholcodine and, of that number, 42 reports of an anaphylactic reaction and 20 reports of anaphylactic shock were recorded.

Noor Hisham said that following the cancellation, all product registration companies are responsible to inform every community pharmacy and clinic supplied with the products to stop selling and ensure the products are quarantined before being returned to the supplier.

“Healthcare workers are also reminded to stop prescribing, dispensing, selling or distributing all products containing pholcodine with immediate effect. Patients suffering from dry cough should be given alternative medicine,” he said, suggesting dextromethorphan. – Bernama, March 23, 2023.