Drug watchdog restricts domperidone use over side-effects

GPs should not prescribe domperidone for bloating or heartburn, the drug regulator has advised, following concerns over cardiac adverse drug reactions.

Domperidone no longer authorised for treating heartburn (photo: iStock)
Domperidone no longer authorised for treating heartburn (photo: iStock)

The MHRA said domperidone (Motilium) should no longer be used to treat conditions such as heartburn, bloating or relief of stomach discomfort, nor should it be used by people with serious underlying heart conditions.

It follows a review by the European Medicines Agency (EMA) that found a small increased risk of serious cardiac adverse drug reactions related to the use of domperidone.

While the drug may still be used to treat nausea and vomiting, GPs should prescribe the lowest effective dose for the shortest duration. The MHRA said adults should take no more than three 10mg tablets per day.

Risk of side effects

The EMA said the benefits outweighed the risks for treating nausea and vomiting, but there was a lack of evidence to support its continued use in other conditions.

The EMA added: '[Domperidone] must not be given to patients with moderate or severe impairment of liver function, or in those who have existing abnormalities of electrical activity in the heart or heart rhythm, or who are at increased risk of such effects.'

Dr Sarah Branch, deputy director of the MHRA’s Vigilance and Risk Management of Medicines Division, said: 'This review looked at the available information in depth. It concluded that the benefits outweigh the risks of using domperidone when used to treat nausea and vomiting but that there should be restrictions on its use. It should no longer be used for symptoms of abdominal discomfort such as heartburn and feelings of fullness.

Dr Branch said patients with underlying heart conditions who take the drug should speak to their doctor or pharmacist at their next routine visit.

Around 45,000 patients used domperidone in the UK in 2012.

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