London: The UK drug regulator ordered a recall of cold and cough medicines containing pholcodine over concerns they could increase the risk of a rare allergic reaction in some patients.
The action follows 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 neuromuscular blocking agents 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 cough, according to the MHRA. Drugs listed on the regulators website as part of the recall include Day & Night Nurse Capsules, sold by GSK Plc spinoff Haleon Plc, and Boots Night Cough Relief Oral Solution.
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.
