Domperidone link to heart problems prompts MHRA warning
Clinical A review by the European Medicines Agency found 342 reports of serious side effects and 57 deaths among those taking domperidone
The use of domperidone (Motilium) should be restricted because of the increased risk of potentially fatal heart problems, the MHRA has warned.
The anti-sickness drug should not be taken by people with a serious underlying heart condition, or to treat heartburn, bloating or relief of stomach discomfort, the medicines watchdog said on Friday (Friday 25).
The drug should only be used to treat nausea and vomiting symptoms, at the lowest effective dose in adults of no more than three 10mg tablets a day in adults, it said.
The use of domperidone should be restricted because of the increased risk of potentially fatal heart problems, says the MHRA |
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The warning was issued after a review by the European Medicines Agency (EMA) found 342 reports of serious side effects and 57 deaths among those taking domperidone. People who take the drug may have a small increased risk of potentially life-threatening effects on the heart, the EMA concluded. |
The review confirmed that while benefits of treatment outweighed the risk, restrictions on its use needed to be in place, Sarah Branch, deputy director of MHRA's vigilance and risk management of medicines division, said.
"There is no need to stop taking your medicines. However, if you have an underlying heart condition or have any other questions, please speak to your doctor or pharmacist at your next routine visit," Ms Branch said.
Patients should report any side effects of the treatment via the Yellow Card scheme, which can be accessed online at www.mhra.gov.uk/yellowcard, she added.
Domperidone is estimated to have been prescribed and used by more than 45,000 patients in 2012, the MHRA said.
Findings from the EMA review will now be sent to the European Commission, which will take an EU-wide legally binding decision.