James Kon
All products containing pholcodine imported and marketed in Brunei Darussalam have been recalled and its registration cancelled by the Brunei Darussalam Medicines Control Authority (BDMCA) after findings showed products containing the substance pose safety risks for users.
Pholcodine is used to treat dry (non-productive/irritating) cough in adults and children. It is also commonly found in lozenges to help relieve sore throats and dry coughs.
In the Sultanate, pholcodine was classified as medicinal products supplied by or under the supervision of a registered pharmacist without a doctor’s prescription in a pharmacy.
Medicinal products containing pholcodine are not supplied to health institutions under the Ministry of Health (MoH). However, products with pholcodine are widely available at private clinics, retail pharmacies and other private health centres, and there is a likelihood that public members may have purchased medicines containing the substance overseas with a surplus stock at home.
According to a statement from the MoH yesterday, the decision is based on a thorough review of post-marketing safety data, including results of the clinical study on Allergy to Neuromuscular Blocking Agents and Pholcodine Exposure, and information obtained from other regulatory agencies in Australia, United Kingdom, European Union and Malaysia.
Findings show that products containing pholcodine pose safety risks for users, such as anaphylaxis (severe and potentially life-threatening allergic reaction) coupled with muscle-relaxant or neuromuscular blocking agents (NMBAs) during general anesthesia in surgeries, especially those who have taken pholcodine in the past 12 months.
So far, the National Adverse Drug Reaction Monitoring Centre, Pharmacovigilance Section, Department of Pharmaceutical Services at the MoH has not received any adverse drug reaction reports following the use of pholcodine in the Sultanate.
However, the World Health Organization (WHO) has reported 42 reports of anaphylactic reaction and 20 reports of anaphylactic shock involving the use of pholcodine, out of which nine cases reported involved the use of pholcodine with NMBA (suxamethonium). The MoH concluded that the risk of pholcodine use outweighs its benefits.
Following the cancellation of registration and product recall, all product licence holders and import licence holders are required to inform every private clinic, health centre and retail pharmacy to stop the sale and distribution of such products with immediate effect.
Healthcare professionals, such as doctors and pharmacists, are also reminded to stop prescribing, dispensing, selling and distributing all products containing pholcodine with immediate effect. Patients suffering from a dry cough should be given alternative treatments.
The public, who has products containing pholcodine, is advised to stop using such products immediately. They are also reminded to check the label or package insert of their medicines especially cough and flu medicines as well as lozenges. Patients, scheduled to undergo surgery requiring the administration of general anaesthesia, are advised to inform healthcare professionals if they have taken products containing pholcodine, especially within the past 12 months.
