News Column

Domperidone to be Available Only as a Prescription Medicine

September 3, 2014



LONDON, Sept. 3 -- The British Medicines and Healthcare Products Regulatory Agency issued the following news release:

From 4 September 2014, people taking domperidone to treat nausea and vomiting will only be able to get this medicine on prescription from their doctor. It will no longer be available from pharmacies without a prescription, the Medicines and Healthcare products Regulatory Agency (MHRA) announced today. This follows advice previously issued by the MHRA in April 2014 about new information on effects on the heart and that domperidone should no longer be used for heartburn, bloating or relief of stomach discomfort.

Dr Sarah Branch, Deputy Director of the MHRA's Vigilance and Risk Management of Medicines Division, said:

"Patient safety is our priority - we continually monitor the safety of medicines after they are licensed so that we can take action if the need arises.

"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.

"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.

"If you have experienced any side effects to this medicine you can report these to us at: www.mhra.gov.uk/yellowcard."

The European Medicines Agency (EMA) recently reviewed the safety and efficacy of domperidone and found that people who take them may have a small increased risk of potentially life-threatening effects on the heart. Therefore the indications for these medicines were restricted to nausea and vomiting.

Following this, the Commission on Human Medicines, the independent advisory body to the MHRA, advised that whilst pharmacists were able to manage the majority of risks identified with this medicine, they would not routinely have access to a patient's full medical history and would not quickly and accurately be able to assess which patients were at risk of cardiac side effects.

A recall to pharmacy level only has been issued because this product should no longer be sold over the counter in pharmacies. Domperidone will now only be available as a prescription-only medicine (POM) with effect from 4 September 2014.

TNS 18EstebanLiz-140904-30FurigayJane-4845675 30FurigayJane


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