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EMA recommends lower dose of nausea relief drug

ClinicalEU medicines watchdog makes decision to reduce the recommended dose of domperidone after a review showed it was associated with heart problems

The European Medicines Agency (EMA) has recommended a reduction in the strength of domperidone medicines, in response to reports of heart problems from patients taking the nausea relief drug.

The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) made the recommendation to reduce the dose to 10mg after a review of the medicine showed it was "clearly associated with a small increased risk of potentially life-threatening effects on the heart", it said on Friday (March 7).

The injectable form of domperidone was withdrawn in 1985 because of its side effects on the heart. The medicine's product information was also updated in 2011 to advise caution in patients with heart conditions, but this had not stopped reports of heart problems, the EMA said.

The EU medicines watchdog made the recommendation to reduce the dose of domperidone after a review showed it was associated with heart problems

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Domperidone should still be used for the management of nausea and vomiting, but not for other conditions such as bloating and heartburn, the committee recommended.

Oral products containing 20mg of the drug and suppositories containing 10mg or 60mg should be withdrawn, it advised. It should not be given to patients with impaired liver function, existing abnormalities in their heart rhythm or taken with other medicines that have a similar effect on the heart, the EMA said.

A dose of 10mg could still be taken three times a day by adults and adolescents weighing 35kg or more and suppositories containing 30mg of the drug could be taken twice daily, the EMA recommended. In children weighing less than 35kg, it recommended an oral dose of 0.25mg per kg of bodyweight up to three times a day.

Measuring devices should be included with liquid formulations to allow doses to be accurately adjusted to the patient's bodyweight and the medicine should not normally be taken for longer than a week, it added.

Domperidone has been widely available in OTC and prescription-only medicines since the 1970s, under trade names such as Motilium. It works by blocking dopamine receptors in the gut and brain that are linked to vomiting.

The recommendation will be referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will decide whether it should be enforced across Europe, including the UK.

What has your experience of domperidone been?

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