Domperidone: risks of cardiac side effects
- Medicines and Healthcare products Regulatory Agency
- 30 May 2014
- Therapeutic area:
- GI, hepatology and pancreatic disorders and Nutrition and dietetics
Indication restricted to nausea and vomiting, new contraindications, and reduced dose and duration of use.
Article date: May 2014
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
- 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
- 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
- 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)
- 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:
Non-prescription availability of domperidone:
Pharmacists are asked to take the following steps when supplying domperidone without prescription:
- Ask questions to exclude supply for people for whom domperidone is contraindicated (see above)
- 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
Advice to give to patients
- Domperidone should only be used for short periods of time to treat nausea and vomiting
- Speak to your doctor or pharmacist at your next routine visit if you are taking domperidone and have any problems with your heart or concerns about your treatment
- Seek medical attention immediately if you experience heart-related symptoms such as irregular heartbeat or fainting while taking domperidone
Letter sent to healthcare professionals on 25 April 2014
MHRA press release 25 April 2014
European Medicines Agency statement 25 April 2014
Article citation: Drug Safety Update volume 7 issue 10, May 2014: A1.
Published: 30 May 2014