Malaysia: Pholcodine: Product Recall and Called-Off Registration

ARQon
Apr 17, 2023
1 min read

The Ministry of Health (MOH) of Malaysia has publicly announced the called-off registration and product recall of Pholcodine on 20 March 2023. The National Pharmaceutical Regulatory Agency (NPRA) has concluded the risk review of Pholcodine brings more harm compared to its benefit, hence, the Drug Control Authority (DCA) has immediately stopped and cancelled all products with Pholcodine-related registration.

Locally, NPRA reports there are 17 adverse events with 12 reports related to Pholcodine products. Among the reactions reported are rashes, urticaria, diarrhea and only 1 case reported breathing difficulty.

Studies show that the use of Pholcodine in the period of 12 months prior to general anesthesia with Neuromuscular Blocking Agents (NMBAs) may cause anaphylactic reactions. In the meantime, there is no safety measure available in order to minimize the risk. Pholcodine is a cough suppressant that helps to control the cough reflex and is classified as Group C in Malaysia. While Neuromuscular Blocking Agents (NMBAs) are used as muscle relaxants during general anesthesia.

Healthcare providers are advised to quarantine remaining stocks and immediately stop prescribing, dispensing or selling to patients. Patients that will undergo surgery should inform about the usage of pholcodine-related products.

Source: NPRA