BRITAIN'S Medicines and Healthcare products Regulatory Agency (MHRA) has announced the complete withdrawal of pholcodine-containing cough and cold medicines from the UK market.
The precautionary move, which mirrors Australia's Therapeutic Goods Administration withdrawal of the medications earlier this month (PD 01 Mar), follows an MHRA review which found that "their benefits do not outweigh the increased risk of the very rare event of anaphylaxis to neuromuscular blocking agents (NMBAs) used in general anaesthesia".
UK pharmacists are being advised not to dispense or sell any pholcodine-containing medicines, to immediately quarantine existing stock for return to manufacturers, and instead "consider recommending appropriate treatment alternatives for patients who present with a new dry cough or who are currently taking pholcodine," the MHRA said.
A similar review by the European Medicines Agency in Dec last year also concluded that the benefits of pholcodine medicines do not outweigh the risks, recommending that the medicines be withdrawn from the EU market.
In Jan 2022 the MHRA added details of a potential reaction to the product information for pholcodine-containing medicines, with the new review considering "cumulative safety information" which showed a significant association with an increased risk of "perianaesthetic anaphylaxis to NMBAs" among patients using the cough and cold medications.
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