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Nausea and vomiting: Domperidone linked to risks of cardiac side effects


Domperidone ( Motilium ) is associated with a small increased risk of serious cardiac side effects. Its use is now restricted to the relief of nausea and vomiting and the dosage and duration of use have been reduced. It should no longer be used for the treatment of bloating and heartburn.
Domperidone is now contraindicated in those with underlying cardiac conditions and other risk factors. Patients with these conditions and patients receiving long-term treatment with Domperidone should be reassessed at a routine appointment, in light of the new advice.
Domperidone is a dopamine antagonist with antiemetic properties.

A European review assessed the benefits and risks of Domperidone following continued reports of cardiac side effects. The review confirmed a small increased risk of serious cardiac side effects. A higher risk was observed particularly in people older than 60 years, people taking daily oral Domperidone doses of more than 30 mg, and those taking QT-prolonging medicines or CYP3A4 inhibitors at the same time as Domperidone.
For indications other than nausea and vomiting, the benefits were not considered to outweigh the cardiac risk.
Based on the results of this review, the treatment advice for Domperidone has been updated.

The overall safety profile of Domperidone, and in particular its cardiac risk and potential interactions with other medications, should be taken into account if there is a clinical need to use it at doses or durations greater than those authorised ( eg, to control side effects of Parkinson’s disease treatment in some patients ).

Domperidone use in children is under further investigation. Domperidone licence-holders are required to conduct studies to provide further data to support Domperidone efficacy in children.

Advice for healthcare professionals

Indication - Domperidone is now restricted to use in the relief of nausea and vomiting. It should be used at the lowest effective dose for the shortest possible time.

Contraindications - Domperidone is now contraindicated in people: with conditions where cardiac conduction is, or could be, impaired; with underlying cardiac diseases such as congestive heart failure; receiving other medications known to prolong QT interval or potent CYP3A4 inhibitors; with severe hepatic impairment.
Patients with these conditions should have their treatment reviewed at their next routine appointment and be switched to an alternative treatment if required.

Posology – A) Oral formulations: for adults and adolescents over 12 years of age and weighing 35 kg or more, the recommended maximum dose in 24 hours is 30 milligrams ( dose interval: 10 milligrams up to three times a day ). In children under 12 years of age and weighing less than 35 kg, the recommended maximum dose in 24 hours is 0.75 mg/kg body weight ( dose interval: 0.25 mg/kg body weight up to three times a day ). B) Suppository formulation: suppositories should only be used in adults and adolescents weighing 35 kg or more, the recommended maximum daily dose in 24 hours is 60 milligrams ( dose interval: 30 milligrams twice a day ).

Duration of treatment - The maximum treatment duration should not usually exceed one week. Patients currently receiving long-term treatment with Domperidone should be reassessed at a routine appointment to advise on treatment continuation, dose change, or cessation.

Administration of liquid formulations - Oral liquid formulations of Domperidone should only be given via appropriately designed, graduated measuring devices ( eg, oral syringes for children and cups for adults and adolescents ) to ensure dose accuracy.

Additional advice for pharmacists

Pharmacists are asked to take the following steps when supplying Domperidone without prescription: a) ask questions to exclude supply for people for whom Domperidone is contraindicated; b) advise people to take Domperidone only for nausea and vomiting [ it should no longer be taken for bloating and heartburn ].
Advise people to take the lowest dose for the shortest possible time up to a maximum daily dose of 3 tablets and for a maximum period of 48 hours. ( Xagena )

Source: MHRA - Drug Safety Update volume 7 issue 10, 2014: A1

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