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UK regulator makes domperidone pharmacy-only

Patients will from now on have to see their GP to get domperidone, after the UK drugs regulator decided to switch the drug to prescription-only status.

The move comes after a European review concluded domperidone is associated with a small but significant increase in the risk of cardiac problems.

As a result of that review, the European Medicines Agency ruled earlier in the year the drug should be used at lower doses and only for the relief of nausea or vomiting, not for other gastrointestinal problems such as dyspepsia or reflux problems.

The Medicines and Healthcare products Regulatory Agency (MHRA) has now gone even further, ruling domperidone – brand name Motilium -should no longer be sold over the counter even as a pharmacy-only medicine.

The MHRA’s advisory body, the Commission on Human Medicines, said patients need a proper cardiac risk assessment before being advised to take it – requiring routine access to medical records that pharmacists don’t currently have.

Dr Sarah Branch, deputy director of the MHRA’s vigilance and risk management of medicines division, said people should consult their GP if currently taking domperidone without prescription.

Dr Branch said: ‘If you are currently taking domperidone without a prescription and wish to continue, speak to your doctor or pharmacist at your next routine visit. There is no problem if you wish to stop and a healthcare professional can advise on suitable alternatives for nausea and vomiting.’

She added: ‘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.’

>>>> Clinical Newswire




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