The Medicines and Healthcare products Regulatory Agency (MHRA) today (March 14) announced that “pholcodine-containing cough and cold medicines are being withdrawn from the UK market as a precaution”.

It follows a review that 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”, it said.

 

The MHRA said pharmacists must not “dispense or sell pholcodine-containing medicines” but instead “consider recommending appropriate treatment alternatives for patients who present with a new dry cough or who are currently taking pholcodine”.

 

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Pharmacies should follow the MHRA’s Class 2 medicines recall notice to stop supplying the products "immediately", “quarantine stock of pholcodine-containing medicines and return it to the manufacturer”, it added.

Pholcodine is an opioid medicine approved in adults and children over six to treat non-productive (dry) cough and, in combination with other active substances, for the treatment of cold and flu symptoms.

 

It is found is many popular cough and cold medicines, although pholcodine-containing products have only been available in the UK for purchase in a pharmacy. 

 

Advice for pharmacists

 

“Pholcodine-containing cough and cold medicines are being withdrawn from sale as a precaution and will no longer be available from pharmacies”, the MHRA said.

 

“Pharmacists should provide advice to those who have any concerns about their medicine or would like to seek advice on alternative medicines or management of their symptoms,” it added.

 

They should tell patients taking any cough medicine including tablets and syrups to check the packaging, label or patient information leaflet to see if pholcodine is a listed ingredient and to talk to their pharmacist if they “have any questions”, it said.

 

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It also said that patients with any questions should “talk to a pharmacist” or their GP, although there is “no increased risk of allergic reactions, including anaphylaxis, with other allergens following pholcodine use”.

 

“The absolute risk in patients who have used pholcodine is very small”, it added.

 

The MHRA urged pharmacists and other healthcare professionals to report any suspected adverse drug reactions to the Yellow Card scheme.

 

Review of pholcodine

 

An MHRA review concluded that “there is evidence that using pholcodine-containing medicines leads to an increased risk of the very rare event of an allergic reaction (anaphylaxis) in patients who receive general anaesthesia involving neuromuscular blocking agents (NMBAs) during surgery”.

 

It follows previous reviews examining the link between prior use of pholcodine and an increased risk of anaphylaxis during general anaesthesia involving NMBAs, the watchdog said.

 

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The potential for cross-reactivity between pholcodine and NMBAs was added to the product information for pholcodine-containing medicines in January last year, it added.

 

The new review considered “cumulative safety information” and recent study results showing that use of pholcodine during the 12 months preceding anaesthesia was “significantly associated with an increased risk of perianaesthetic anaphylaxis to NMBAs”, it said.

 

“Very small risk”

 

The Commission on Human Medicines (CHM) advised that there is “sufficient overall evidence for an association with pholcodine, although the absolute risk of anaphylaxis remains very small in patients who have taken pholcodine”, according to the MHRA. 

 

“Given the advice of the CHM, and the lack of identifiable effective measures to minimise the increased risk of anaphylactic reactions to NMBAs, pholcodine-containing products are being withdrawn from the market as a precaution.”, it said.

 

The MHRA review took place alongside another conducted by the European Medicines Agency (EMA), which also concluded that the benefits did not outweigh the risks and recommended the withdrawal of medicines containing pholcodine from the EU market.