KUALA LUMPUR – The recent recall of numerous cough medications containing the opioid pholcodine by the Health Ministry was necessary and a standard procedure, health organisations say.
While the issuance for immediate recalls might ring an alarm to consumers, Malaysian Medical Association president Dr Muruga Raj Rajathurai said the practice is not out of the ordinary, as such cases have occurred before.
He said pharmaceuticals consistently monitor medications after they reach the market, following continuous research and information.
“Pharmaceuticals, even though registered and approved for use, will undergo constant post-market surveillance,” he told The Vibes.
“There is constantly new data available even if a product has been on the market for many years.
“If a safety issue is found, the product may either need to be recalled or issued with additional safety alerts. In this case, the safety issue was such that products containing pholcodine had to be taken off the market.
“This is nothing new, as various products have been recalled or discontinued before, due to safety concerns,” he added.
Muruga explained that the reasoning behind the product recalls is due to the effects when pholcodine is combined with neuromuscular blocking agents, which are used as muscle relaxants during general anaesthesia.
Reports showed that individuals who have consumed medication consisting of pholcodine, up to 12 months prior to surgeries, may risk developing anaphylactic reactions.
He also indicated that people who are not undergoing surgical procedures to seek other medication, as one will not know when surgery may be required in the near future.
Similarly, Malaysian Pharmacists Society president Amrahi Buang said the recall was a necessary measure by the Health Ministry, considering new findings on the effects of the products by regulatory agencies.
He added that such post-marketing surveillance is standard procedure worldwide.
“After new findings from the pharmacovigilance of these products, the recall is necessary,”
“This is the standard practice since pharmaceuticals are highly regulated throughout the world,” he told The Vibes.
The Health Ministry had previously issued an immediate recall on 14 cough medication products registered under the Drug Control Authority containing the opioid pholcodine, after finding that the substance posed safety risks.
Those who have taken medication containing the substance in the past 12 months are advised to inform their doctors prior to surgeries, especially those involving general anaesthesia. Patients with non-productive coughs are recommended to seek alternative medications for their ailments instead. – The Vibes, March 26, 2023
