Posted: Tue 14th Mar 2023

Over-the counter cough medicines containing pholcodine withdrawn due to safety concerns

News and Info from Deeside, Flintshire, North Wales
This article is old - Published: Tuesday, Mar 14th, 2023

A number of over-the-counter cough medicines are being withdrawn due to safety concerns.

The Medicines and Healthcare products Regulatory Agency (MHRA) has reviewed post-marketing safety data and found that pholcodine, an ingredient in certain cough medicines, can increase the very rare risk of anaphylaxis, a severe allergic reaction.

As a result, the Commission on Human Medicines (CHM), an independent advisory body, recommended that pholcodine-containing medicines should be withdrawn.

Pholcodine is known to be a risk factor for developing anaphylactic reactions to neuromuscular blocking agents (NMBAs) used in general anaesthesia.

Given the risk and the lack of measures to reduce it, all pholcodine-containing medicines are being withdrawn from the UK market as a precaution.

These products can be bought without a prescription, but only under the supervision of a trained pharmacist.

People are advised to check the packaging of any cough medicines they have at home to see if pholcodine is listed.

If so, they should speak to their pharmacist to get a different medicine.

Those medicines being withdrawn:

The Boots Company PLC

Product name

  • 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 Limited

Product name

  • 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 & Company (Druggists) Limited

Product name

  • 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 Limited

Product name

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

LCM Limited

Product name

Pholcodine Linctus, PL 12965/0030

Glaxosmithkline Consumer Healthcare (UK) Trading Limited

Product name

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

 

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