In April, the MHRA said GPs should no longer prescribe domperidone for bloating or heartburn, following a review by the European Medicines Agency that found a small increased risk of serious cardiac adverse drug reactions relating to its use.
The announcement means patients can now acquire domperidone (Motilium), previously available OTC, only with a prescription from their doctor.
The Commission on Human Medicines, which advises the MHRA, said because pharmacists do not routinely have access to full medical histories, they would be unable quickly and accurately to assess which patients were at risk of cardiac side-effects.
Dr Sarah Branch, deputy director of the MHRA’s Vigilance and Risk Management of Medicines Division, said patients taking domperidone without a prescription who wished to continue were advised to speak to their GP or pharmacist.
She 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.'
Around 45,000 patients were prescribed domperidone in 2012.