Pholcodine Product Recall: Understand Its Mechanism & Safety Concerns

If you’re familiar with some of the common cough syrups preparation available in your local pharmacy, you’ll definitely have heard of Pholcodine, an antitussive (cough suppressant) given for dry cough. Examples of Pholcodine containing cough syrups/lozenges available in Malaysia registered by the Drug Control Authority (DCA) are as below:
 

(Ministry of Health Malaysia)

Understanding the Mechanism of Pholcodine

Indicated as a cough suppressant, Pholcodine is an opioid type medicine given in adults and children age 2 and above for the treatment of non-productive (dry) cough. It acts primarily by depressing the cough reflex within the brain through a direct effect on the cough center. Pholcodine is also sometimes used in combination with other active substances to treat symptoms of cold and flu.

In Malaysia, Pholcodine is classified as a Group C item, which means it can only be sold as a dispensed medicine with an entry in the Prescription Book by a community pharmacist in a pharmacy.

Safety Concerns on Pholcodine

Following a thorough investigation by the Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) and the concurrent Pholcodine medications withdrawals in the UK, Australia and a recommendation for withdrawal by the European’s Regulatory Agency (EMA), the registration of ALL Pholcodine containing products have been canceled and all available preparations are warranted to be off the market, effective immediately on the 20th March 2023. But why is this so?

The NPRA’s decision to recall Pholcodine containing medicines is linked to a recently concluded French clinical study (the ALPHO study) where they demonstrated a possible association between Pholcodine and a very rare, but serious anaphylactic reactions (severe life threatening allergic reaction) to neuromuscular blocking agents (NMBAs) used as general anesthesia in medical surgeries, if they have been used together in the past 12 months. The NPRA has found the risk of Pholcodine use to outweigh its benefits and hence concluded to temporarily quarantine and withhold any Pholcodine product preparations.

In other words, those who took Pholcodine in the last 12 months are at a higher risk of anaphylaxis if they’re given any NMBAs as anesthesia during surgeries.

Other Side Effects of Pholcodine

To date, there are a total of 12 reports with 17 adverse events suspected to be in association with Pholcodine containing products to the NPRA, with no local cases of anaphylactic reactions yet. The reported adverse effects were diarrhoea, rash, breathing difficulty and urticaria.

Whereas for NMBAs, adverse reports received include anaphylactic shock, anaphylaxis, and anaphylactic reactions. However, none of these were reported previous exposures towards pholcodine. 

What cough syrup can I take now if I have a dry cough?

Dextromethorphan is a good alternative indicated for dry cough in Malaysia. Some examples of Dextromethorphan containing preparations are Hosolvan DM Elixir, Sedilix DM Linctus, Tussidex Forte Lincuts; just to name a few. For more information, kindly consult your nearest pharmacist or doctor or you may refer to the registered Dextromethorphan products in Malaysia here: Dextromethorphan preparations

“I was just prescribed with Pholcodine last week”// “Took Pholcodine in the past 12 months”// “Still have Pholcodine at home” What do I do?

Public who had recent Pholcodine exposure who will be undergoing any medical surgery soon should inform their doctor before they have surgery, especially if they took it in the past 12 months. Even if you don’t think you’re going to have a medical procedure soon, for safety reasons, you should stop taking it immediately and consult your pharmacist or physician for other alternatives. On the other hand, leftover Pholcodine at home is advised to be returned to your nearest pharmacy or doctor so necessary actions can be taken and for medication safety disposal. 

On that note, MOH also encourages everyone to report any suspected adverse effects after taking Pholcodine to the NPRA. This can be done by filling out the report form Consumer Side Effect Reporting Form

For virtual doctor assistance, you may always consult our certified doctors online on the use of cough syrups or any concerns you wish to address. Simply download the DOC2US on the App Store or Google Play Store and you will be connected to either one of them. 

This article is written by Janelle Leong, Bpharm(Hons) (DOC2US),
reviewed by Dr. Izzan Nadira binti Ismi, MB Bch BAO (DOC2US)

References

1. https://npra.gov.my/index.php/en/industry/more-regulations/recent-updates/449-english/safety-alerts-main/safety-alerts-2023/1527471-pholcodine-risk-of-anaphylaxis-to-neuromuscular-blocking-agents-nmbas.html 
2. https://theconversation.com/why-cough-medicines-containing-pholcodine-can-be-deadly-even-if-you-took-them-months-before-surgery-200895
3. https://inovapharma.com/pholcodine-recall-my/
4. https://codeblue.galencentre.org/2023/03/23/malaysia-recalls-pholcodine-cough-medicines-over-allergy-fears/ 

Written by

Janelle Leong, Bpharm(Hons)