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Domperidone – concerns over cardiac risk

The European Medicines Agency (EMA) has announced that they are beginning a review of domperidone, an antiemetic, because of concerns about adverse cardiac events.1

The review was triggered by the Belgian medicines agency, the Federal Agency for Medicines and Health Products (FAMHP), over concerns about its adverse effects on the heart. Adverse heart effects, including QT prolongation and arrhythmias, have previously been evaluated by the Pharmacovigilance Working Party (PhVWP).

In 2011, the PhVWP recommended that the product information for domperidone-containing medicines be updated to reflect the risk of these adverse effects and that domperidone should be used with caution in patients with certain heart conditions, including heart failure, a previous heart attack, angina and heart rhythm disorders.

Since then, new reports of heart effects have been received in Belgium and the Belgian medicines agency has come to the view that domperidone should no longer be used in some patients, such as those with QT prolongation or other underlying heart problems.

The EMA will now review all available data on the benefit-risk balance of domperidone-containing medicines, and issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the European Union.

References

1. European Medicines Agency. Review of domperidone started. March 8, 2013. Available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Domperidone-containing_medicines/human_referral_prac_000021.jsp (accessed April 23rd)

Published on: April 26, 2013

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  • ArrhythmiaAlliance
  • Stars
  • Anticoagulation Europe
  • Atrial Fibrillation Association
 

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