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The TGA is reviewing new information regarding domperidone (Motilium) and its potential effects on the patient's heart, particularly with doses above 30 mg daily.
Domperidone is a medicine used for relief of symptoms of nausea and vomiting, and delayed stomach emptying.
The European Medicine Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has recently recommended restricting the dose of domperidone to less than 30 mg daily and duration of use to one week due to the risk of heart problems, including QT prolongation and arrhythmias. The process for considering whether to implement these changes across the European Union is ongoing. The PRAC recommendation is scheduled to be formally assessed on 22-24 April 2014.
In addition to reviewing the PRAC recommendation, the TGA will be assessing new information provided by the sponsor, Janssen-Cilag, to evaluate the benefit-risk profile of domperidone and determine if new measures are required to ensure its safe use in Australia. In particular, the TGA will consider whether any changes should be made to the maximum dose and duration of use for Australian patients.
The TGA is also continuing to monitor all adverse event reports involving heart problems associated with domperidone treatment.
Information for consumers
This monitoring communication highlights a potential safety concern. For most people, taking domperidone is safe.
However, if you have existing heart problems, check with your health professional to make sure that this medicine is appropriate for you.
If you experience any symptoms that could be caused by abnormal heart rhythms, including dizziness, fainting or heart palpitations, stop taking domperidone and seek medical attention.
If you have any questions or concerns about this issue, speak to your health professional.
Information for health professionals
Domperidone should be used at the lowest effective dose for the shortest time possible.
Discuss the benefits and risks of domperidone treatment with patients who are taking, or for whom you may prescribe, this medicine.
Patients with underlying cardiovascular risk factors may be at higher risk, including people taking any medicines known to prolong the QT interval. Domperidone should not be used with medicines that prolong QT interval or with medicines that inhibit CYP3A4. Additionally, domperidone should not be used in patients with moderate to severe hepatic impairment.
For patients who are receiving long-term domperidone therapy, regularly review the treatment to assess effectiveness, adverse events and development of cardiovascular risk factors.
Reporting problems
In addition to adverse events involving domperidone, consumers and health professionals are encouraged to report all problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.