Other safety alerts
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| Australia: Monitoring communication: Domperidone (Motilium) and effects on the heart |
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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.
Health professionals are advised that domperidone should be used at the lowest effective dose for the shortest time possible. 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.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/safety/ews-medicine-domperidone-140402.htm#.UzuRfUzyx9A
In Hong Kong, there are 51 registered pharmaceutical products containing domperidone. Related news regarding the risk of cardiac disorder has been released by Health Canada, HSA and EMA, and was posted on the Drug Office website on 8 March 2012, 21 April 2012 and 8 March 2014. Letters to inform healthcare professionals were issued on 8 March 2012 and 8 March 2014. The issue has been discussed in the meeting of The Registration Committee of the Pharmacy and Poisons Board on 28 February 2012. The Committee decided that the sales pack or package insert of domperidone-containing products should be updated to include the appropriate safety information related to cardiovascular risk. As reported on 8 March 2014, the matter will be further discussed in the meeting of Registration Committee of the Pharmacy and Poisons Board in response to the EMA’s recommendation. So far, the Department of Health has not received any adverse reaction report in connection with drug.
Ends/ Wednesday, April 2, 2014
Issued at HKT 14:00
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