[Note: Pholcodine is not approved by the U.S. Food and Drug Administration (FDA) for use in the United States.]
Cough medicines containing the active ingredient pholcodine are being withdrawn from sale due to safety concerns highlighted for years both in Australia and internationally.
On February 27, Australia’s medicines regulator announced the immediate registration cancellation and recall of dozens of these over-the-counter cough medicines and lozenges. This is because of the risk of a sudden, severe, and life-threatening allergic reaction if people are also given specific muscle relaxant drugs while under a general anesthetic. That risk of anaphylaxis can remain for weeks and months after taking the cough medicine.
What is pholcodine?
Pholcodine (pronounced pho-co-dean) is an opioid-based medicine, which means it’s related to morphine and codeine. It works by binding to various opioid receptors in a part of the brain responsible for triggering the cough reflex.
As such, it is a common ingredient in many over-the-counter medicines used to treat a dry cough. These include cough syrups and lozenges. Every product that contains pholcodine will list it prominently on the bottle or cardboard packaging. Common brands that contain this ingredient include Benadryl, Bisolvon, Codral, Difflam, Difflam Plus, and Duro-Tuss.
Why the recall?
The most common side effects of pholcodine are dizziness, nausea, and sedation. But the Therapeutic Goods Administration (TGA) has recalled products containing it, as pholcodine can trigger anaphylaxis (a severe, life-threatening allergic reaction) around the time of surgery. The issue arises when pholcodine medicines are combined with types of muscle relaxants given during surgery known as neuromuscular blocking agents.
This type of anaphylaxis can occur in people who have had a muscle relaxant before and been previously fine, or in people who receive a muscle relaxant drug for the first time. Being obese also places people at higher risk of this type of anaphylaxis.
We’ve known about the risk for years
We have actually known about the risks of pholcodine and muscle relaxants for some time, including in Scandinavian studies in 2005. In fact, it was because of these studies that it was withdrawn from the market in Norway in 2007.
The European Medicines Agency recommended the withdrawal of pholcodine in Europe in December 2022. In Australia, the PatientSafe Network has been calling for its ban since at least 2017. Over the past 12 months, there were nine reported cases of serious adverse effects to pholcodine reported to the TGA, including three deaths. The most recent case was in January this year. In three of the nine, pholcodine was the only suspected medicine involved.
Why now?
The TGA’s decision may come from a recent (but not yet peer-reviewed) French study. This found that when patients had taken pholcodine at any time in the 12 months before surgery that used a muscle relaxant, they were at much higher risk of anaphylaxis.
The French research is consistent with an earlier Western Australian study that found anaphylaxis is 14 times more likely to occur when the two types of drugs are combined. This is because pholcodine can linger in the body for long periods. After you swallow the medicine, the drug reaches its highest concentration in the bloodstream one to two hours later. But both the drug and its metabolites can still be detected in the body up to seven weeks later.
I have some at home. What now?
As pholcodine can linger in the body, the TGA has warned that if you have taken a medicine containing this in the past 12 months, you need to tell your doctor before you have surgery. If you are taking one of these medicines, you should stop immediately, even if you don’t think you’re going to have a medical procedure soon. Take it to your local pharmacy for disposal. At that time, the pharmacist will be able to recommend a different medicine for your cough.
This article is republished from The Conversation under a Creative Commons license. Read the original article.
Nial Wheate, Associate Professor of the Sydney Pharmacy School, University of Sydney, and Tina Hinton, Associate Professor of Pharmacology, University of Sydney
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