UK pharmaceutical manufacturers including GSK Plc and Boots have been ordered to recall cold and cough medicines containing pholcodine over concerns they could increase the risk of a rare allergic reaction in some patients undergoing operations.
(Bloomberg) — UK pharmaceutical manufacturers including GSK Plc and Boots have been ordered to recall cold and cough medicines containing pholcodine over concerns they could increase the risk of a rare allergic reaction in some patients undergoing operations.
The UK drugs regulator announced the move following a review of evidence showing that the use of pholcodine during the 12 months preceding anesthesia was significantly associated with an increased risk of anaphylaxis when exposed to muscle relaxants used to put people under general anesthetic, the Medicines & Healthcare products Regulatory Agency said on Tuesday.
Pholcodine is an opioid medicine approved to suppress dry coughs, according to the MHRA. Drugs listed on the regulators website as part of the recall include Day & Night Nurse Capsules, sold by GSK spinoff Haleon Plc, and Boots Night Cough Relief Oral Solution, along with products from four more manufacturers.
The MHRA’s advice follows a similar recommendation by the European Medicines Agency in December. The MHRA said in February that it was conducting a safety review of cough, cold and allergy medicines containing pseudoephedrine because of potential side effects to the brain.
“If you have an operation scheduled using general anaesthesia, tell your anesthetist if you think you have used pholcodine, particularly in the past 12 months,” Alison Cave, MHRA chief safety officer, said in the statement.
All of the companies involved in the recall either declined to comment or didn’t immediately return calls seeking comment.
(Updates with more details on recall starting in first paragraph)
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