Pholcodine-containing cough and cold medicines are being withdrawn from the UK market as a precaution following an MHRA review which found that their benefits do not outweigh the increased risk of the very rare event of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 (NMBA) used in general anaesthesia.

Pharmacies are being advised not to dispense or sell pholcodine-containing medicines and recommend appropriate alternatives for patients who present with a new dry cough or who are currently taking pholcodine.

They should follow the MHRA Class 2 Medicines Recall Notice to quarantine stock of pholcodine-containing medicines and return it to the manufacturer.

Pholcodine is an opioid medicine approved in adults and children older than 6 years of age to treat non-productive (dry) cough and, in combination with other active substances, for the treatment of symptoms of cold and influenza.

Previous reviews have examined the link between prior use of pholcodine and an increased risk of anaphylaxis during general anaesthesia involving NMBAs. The potential for cross-reactivity between pholcodine and NMBAs was added to the product information for pholcodine-containing medicines in January 2022.

The latest MHRA review considered the cumulative safety information, including the results from the recently completed ALPHO study, which showed that use of pholcodine during the 12 months preceding anaesthesia was significantly associated with an increased risk of perianaesthetic anaphylaxis to NMBAs.

Anaphylaxis following use of NMBAs is roughly estimated as having an overall incidence of fewer than 1 case per 10,000 procedures, but given the lack of effective measures to minimise the increased risk of anaphylactic reactions, pholcodine-containing products are being withdrawn from the market as a precaution.

Pholcodine products affected by the recall include those from:

The Boots Co:

• Boots Night Cough Relief Oral Solution, PL 00014/0230
• Boots Dry Cough Syrup 6 Years+, PL 00014/0523
• Boots Day Cold & Flu Relief Oral Solution, PL 00014/0565

Thornton & Ross

• Cofsed Linctus, PL 00240/0097
• Care Pholcodine 5mg/5ml Oral Solution Sugar Free, PL 00240/0101
• Galenphol Linctus, PL 00240/0101
• Galenphol Paediatric Linctus, PL 00240/0102
• Galenphol Strong Linctus, PL 00240/0103
• Covonia Dry Cough Sugar Free Formula, PL 00240/0353

Bell Sons & Co

• Pholcodine Linctus Bells Healthcare 5mg Per 5ml Oral Solution, PL 03105/0059
• Numark Pholcodine 5mg per 5ml Oral Solution, PL 03105/0059
• Well Pharmaceuticals Pholcodine 5mg per 5ml Oral Solution, PL 03105/0059
• Superdrug Pholcodine Linctus BP, PL 03105/0059
• Strong Pholcodine Linctus BP, PL 03105/0060

Pinewood Laboratories

• Pholcodine Linctus BP, PL 04917/0002
• Strong Pholcodine Linctus BP, PL 04917/0005

LCM Ltd

• Pholcodine Linctus, PL 12965/0030

Glaxosmithkline Consumer Healthcare (UK)

• Day & Night Nurse Capsules, PL 44673/0068
• Day Nurse Capsules, PL 44673/0069
• Day Nurse, PL 44673/0075