Following a European review, the Medicines and Healthcare products Regulatory Agency (MHRA) is issuing updated advice today that domperidone should not be used by people who have serious underlying heart conditions. It should only be used in the relief of symptoms of nausea and vomiting and at the lowest effective dose for the shortest possible duration. Adults should take no more than three 10mg tablets per day. Domperidone should no longer be used to treat other conditions such as heartburn, bloating or relief of stomach discomfort.
This new advice follows a European Medicines Agency’s (EMA’s) review on the safety and effectiveness of domperidone. The review found that people who take the drug may have a small increased risk of potentially life-threatening effects on the heart.
Dr Sarah Branch, Deputy Director of 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.
“There is no need to stop taking your medicine. 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.
“If you have experienced any side effects to this medicine you can report these to us at: www.mhra.gov.uk/yellowcard”.