Doctors Warn of Dangers of Pholcodine Cough Syrups

The World Health Organisation (WHO) alerted people about using Pholcodine in cough syrups earlier this year, and India’s drug regulator has now asked doctors to stop prescribing such medicines. The Drugs Controller General of India (DCGI), on July 14, issued an advisory to stop the use of this substance, which is used in various over-the-counter cold and cough remedies. The medicine suppresses the cough center in the brain by reducing nerve signals that trigger coughing. It can cause several side effects, including constipation, drowsiness, certain gastrointestinal disturbances, and in very high doses, even respiratory depression.

The European Medicines Agency (EMA) has found a minimal chance — less than one in 10,000 — that some consumers who take pholcodine-containing medicines may experience a severe allergic reaction when they need general anesthesia and are given neuromuscular blocking agents, which paralyze patients during surgery. In the UK, the medicines watchdog has already withdrawn and canceled all medications containing Pholcodine as a precaution because of these findings.

A similar move was taken in Australia, where the Therapeutic Goods Administration (TGA) canceled the registration of all cough syrups and lozenges containing this substance after a review by its safety committee recommended revoking the marketing authorizations. More than 50 pholcodine-containing cough syrup and lozenge products remain on sale in Australian pharmacies, but the TGA says they should be removed from shelves immediately as a safety precaution.

In the US, the Food and Drug Administration (FDA) has issued a public health advisory to warn about the possible risk of allergic reactions from taking pholcodine-containing medications for symptomatic relief of a cough or sore throat. The FDA said the Pholcodine in these products is an opioid that works by suppressing the cough center in the brain and can have serious adverse events, including seizures in children.

Pholcodine has been used since the 1950s in a wide range of over-the-counter pharmacy medicines to treat non-productive cough and is mainly used in cough syrups and lozenges. It is also combined with other ingredients for other cold and flu symptoms. These medicines include over-the-counter tablets, capsules, and liquids.

If you have a cough or sore throat, pharmacists recommend staying home and resting as much as possible to help reduce the symptoms. See your doctor for advice if the symptoms do not improve after a few days. They can suggest appropriate over-the-counter medicine or alternative herbal remedies such as thyme, ivy, and marshmallow root, which have been shown to have cough-relieving properties. The TGA and MHRA also advise healthcare professionals to verify that patients scheduled for surgical procedures requiring general anesthesia with NMBAs have not taken pholcodine-containing cough medicines in the past 12 months. Healthcare professionals should also be aware of these patients’ potential for anaphylactic reactions.