Pholcodine

Pharmacists told to stop supplying 20 brands after review finds raised risk of rare anaphylaxis in people who later have general anaesthetic.

Pholcodine has been used as a cough suppressant since the 1950s. The EMA’s decision drew on results from the [Alpho study](https://www.medrxiv.org/content/10.1101/2022.12.12.22283353v1), which found that the risk of NMBA-related anaphylaxis, a severe allergic reaction to NMBAs, was four times greater when patients had taken pholcodine. Anyone who is due to have surgery should tell their anaesthetist beforehand if they believe they have taken pholcodine, particularly in the past 12 months. “A cough usually clears up within three to four weeks. The alert continued: “NMBAs are used to relax the muscles during general anaesthesia for some surgical procedures. If it is, then pharmacists can advise on alternative medicines, the recall notice says.

Products containing pholcodine to be recalled over the risk of a very rare, but serious allergic reaction.

Prof Claire Anderson, from the Royal Pharmaceutical Society, said: "The risk to patients who have used pholcodine is very small. [Europe's medicines regulator](https://www.ema.europa.eu/en/news/ema-recommends-withdrawal-pholcodine-medicines-eu-market) has already made the same recommendations to recall cough products containing pholcodine. - Strong Pholcodine Linctus BP - Pholcodine Linctus BP - Superdrug Pholcodine Linctus BP - Galenphol Linctus

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the withdrawal of pholcodine-containing cough and cold medicines from the UK ...

“The risk to patients who have used pholcodine is very small. “Anyone that has any cough or cold remedies in their medicine cupboard should check to see if any contain pholcodine and if so get rid of them. Coughs and colds are common illnesses and although people who know they might need a general anaesthetic for a planned surgical procedure could avoid using pholcodine containing medicines, because the risk lasts for a very long time – 12 to 36 months after exposure – and also because surgery requiring use of a muscle relaxant might be needed in an emergency – appendicitis for example – it is not easy to reduce this risk simply by warning people about it. Following pholcodine containing medicines being removed from the market in Norway the risk of serious allergic reactions to muscle relaxants given during a general anaesthetic fell very markedly (Florvaag et al. “MHRA have come to this decision because there is no clear method which can be used to decrease the very small – but potentially life threatening – risk of serious allergic reactions among patients receiving a muscle relaxing treatment during a general anaesthetic other than by removing the medicine from the market. “The decision to withdraw these medicines was taken following the release of data from the ALPHO study, a case control study which conducted in France.

All cough and cold medicines containing pholcodine will be withdrawn from the UK market as a precautionary measure, the medicines watchdog has announced.

“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. 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”. “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. [MHRA’s Class 2 medicines recall notice](https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-various-marketing-authorisation-holders-pholcodine-containing-products-el-23-a-slash-09) to stop supplying the products "immediately", “quarantine stock of pholcodine-containing medicines and return it to the manufacturer”, it added. 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. [(MHRA) today (March 14) announced](https://www.gov.uk/drug-safety-update/pholcodine-containing-cough-and-cold-medicines-withdrawal-from-uk-market-as-a-precautionary-measure) that “pholcodine-containing cough and cold medicines are being withdrawn from the UK market as a precaution”.

All products containing pholcodine, including over-the-counter cough syrups, have been recalled due to a risk of anaphylaxis.

‘Anyone that has any cough or cold remedies in their medicine cupboard should check to see if any contain pholcodine and if so get rid of them. ‘Although pholcodine is effective in suppressing cough, most illnesses causing coughs will recover, even if not treated, within 1-2 weeks and other medicines which can sooth cough are available if needed. - Pholcodine Linctus BP, PL 04917/0002 - Strong Pholcodine Linctus BP, PL 03105/0060 - Superdrug Pholcodine Linctus BP, PL 03105/0059 - Galenphol Linctus, PL 00240/0101

Some cough medicines are being removed from UK pharmacy shelves due to safety risks. All products which contain pholcodine, a cough suppressant, ...

“The risk to patients who have used pholcodine is very small. If your cough persists for longer than three to four weeks seek advice from a healthcare professional." Pholcodine Linctus BP Strong Pholcodine Linctus BP Superdrug Pholcodine Linctus BP Pholcodine Linctus Bells Healthcare 5mg Per 5ml Oral Solution,

Its assessment suggests people who consumed products containing pholcodine may experience a severe allergic reaction to muscle relaxants known as neuromuscular ...

- PL 03105/0059 Strong Pholcodine Linctus BP, PL 03105/0060Pholcodine Linctus BP, - PL 44673/0069 Day Nurse, PL 44673/0075 - PL 04917/0005 Pholcodine Linctus, However, the United States doesn’t allow it to be prescribed as it’s within its most highly controlled - PL 00240/0101 Galenphol Paediatric Linctus, - PL 00240/0101 Galenphol Linctus,