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The European Medicines Agency (EMA) recently reviewed the safety and efficacy of medicines containing 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, reviewed the safety of this medicine for supply over the counter in a pharmacy and advised that medical supervision was needed. Domperidone will now only be available as a prescription-only medicine (POM) with effect from 4 September 2014.
Key messages
Q: What is domperidone and what does it do?
A: Domperidone is a medicine to stop you feeling sick (nausea) or being sick (vomiting). The brand name of domperidone is Motilium.
Q: Why can I no longer buy domperidone without a prescription?
A: As with any medicine, domperidone may cause side effects in some people. It can cause irregular heartbeats (heart arrhythmia) and may slightly increase the risk of death due to heart problems. These are serious side effects but the chance that they may happen is very low. This risk may be slightly higher in some people, especially those who are older than 60 years and those who take more than 30 milligrams of domperidone a day .
The benefits of domperidone still outweigh the risk of these side effects for some people. However, a doctor will review your medical history and information about the other medicines you are taking and consider the need for any tests to decide whether domperidone is suitable for you. For this reason, you can no longer buy domperidone without a prescription.
Q: What should I do if I’ve bought domperidone without a prescription?
A: If you have recently bought domperidone without a prescription and you wish to continue taking it, speak to your doctor or pharmacist at your next routine visit. There is no problem if you wish to stop and your doctor or pharmacist can advise on suitable alternatives.
Q: What should I do if I’ve been prescribed domperidone?
A. If you have been prescribed domperidone there is no need to stop taking your medicine. Continue to take it as instructed by your doctor or nurse.
Speak to your doctor or pharmacist at your next routine visit if you have any problems with your heart, are taking medicines that affect your heart, or have liver problems. They may recommend an alternative treatment if needed.
Q: How do I report any side effects?
A: Whether you have bought domperidone with or without a prescription, talk to your doctor straight away if you have any of the following symptoms while taking domperidone:
13-September-2014