Pholcodine: Risk of Anaphylaxis to NMBAs

Drug Safety Update

In Malaysia, pholcodine is a Group C poison, which is dispensed for the relief of unproductive, irritating coughs in adults and children above 2 years of age.

On the other hand, neuromuscular blocking agents (NMBAs) (such as rocuronium, atracurium, cisatracurium, mivacurium and suxamethonium) are used as muscle relaxants during general anaesthesia.

  • NMBAs are the most common drugs that can potentially cause perioperative anaphylaxis, which accounts for about 60% of reactions that can lead to perioperative morbidity and mortality.

Research has shown that the use of pholcodine within12 months prior to general anaesthesia with NMBAs is a significant risk factor for developing an anaphylactic reaction to NMBAs.



Recommendations

To mitigate the risk, all pholcodine-containing cough products have their marketing authorisation withdrawn, effectively from 20 March 2023.

  • A drug recall of Degree II (within 72 hours) and Level A (to all consumers) is initiated.
  • Patients are advised to avoid pholcodine-containing products and use alternative treatment for cough.

For patients scheduled to undergo clinical procedures requiring the administration of NMBA, health care providers should

  • Check their medication history to identify if they have taken pholcodine in the past 12 months, as well as any other risk factors (such as obesity).
  • Keep patients aware of potential anaphylactic reactions to NMBAs.



External Links

Comments

Post a Comment