DOMPERIDONE will no longer be available to patients without a prescription from a doctor, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced.
The European Medicines Agency (EMA) recently reviewed the safety and efficacy of domperidone and found that people who take the drug may have a small increased risk of potentially life-threatening effects on the heart.
This follows advice previously issued by the MHRA in April 2014 that domperidone should no longer be used for heartburn, bloating or relief of stomach discomfort. Indications for the medicine are now restricted to nausea and vomiting.
Dr Sarah Branch, Deputy Director of the MHRA’s Vigilance and Risk Management of Medicines Division, said: "People who have been prescribed domperidone from their doctor should continue to take their medicine as instructed as their medical history and any tests will have been assessed before they are given this medicine.
"That is why we have changed this medicine to prescription only so that patients can be assessed for any underlying medical conditions that may affect their suitability for domperidone. 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."