Domperidone must be supplied on prescription, MHRA rules

Domperidone (Motilium), used to treat nausea and vomiting, will be a prescription-only medicine from 4 September 2014.

Medicines and Healthcare Products Regulatory Agency

Domperidone (Motilium), used to treat nausea and vomiting, will be a prescription-only medicine (POM) from 4 September 2014, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced.

The move is part of a class 2 medicines recall triggered by concerns about the potential cardiotoxicity of the drug, which is a dopamine antagonist with antiemetic properties. A recent European Medicines Agency (EMA) review found that domperidone was associated with a small increased risk of serious cardiac side effects.

In May 2014, the MHRA’s monthly
Drug Safety Update
responded to the EMA review. It warned that domperidone should no longer be used for the treatment of bloating and heartburn and that the drug was contraindicated in people with underlying heart conditions and other risk factors. It also said the drug’s use in children was under review.

The pharmacy-level recall follows discussions between the MHRA and the Commission on Human Medicines, which advised that domperidone is safe for supply under medical supervision. Pharmacists would not be able to quickly and accurately assess which patients were at risk of cardiac side effects, it said.

Pharmacists now have 48 hours to remove over-the-counter domperidone products from the shelves. The MHRA said it had been liaising with the Royal Pharmaceutical Society (RPS) and the National Pharmacy Association (NPA) to disseminate the message.

“If you are currently taking domperidone without a prescription and wish to continue, speak to your doctor or pharmacist at your next routine visit,” said Sarah Branch, deputy director of the MHRA’s Vigilance and Risk Management of Medicines Division. “There is no problem if you wish to stop, and a healthcare professional can advise on suitable alternatives for nausea and vomiting.” 

Last updated
Citation
The Pharmaceutical Journal, PJ, 13 September 2014, Vol 293, No 7827;293(7827):DOI:10.1211/PJ.2014.20066338