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MHRA issues alert on risks associated with domperidone

Filed May 23rd, 2012 Laurie

Health regulators in the United Kingdom have issued a safety alert on drugs containing domperidone because they carry a slight risk of serious ventricular arrhythmia and sudden cardiac death.

In the U.K., domperidone is dispensed in prescription-strength form for the treatment of nausea and vomiting, epigastric sense of fullness, upper abdominal discomfort, and regurgitation of gastric contents in adults, according to a statement from the Medicines and Healthcare products Regulatory Agency (MHRA).

A recent review of drugs containing domperidone in Europe found they carry a slight risk of these life-threatening side effects, especially in patients older than 60 or for those who take daily doses more than 30 mg. The maximum dose available in the U.K. is 80 mg. QT prolongation and ventricular arrhythmia are already known side effects of these drugs and MHRA is advising doctors to avoid prescribing these drugs to patients with a prior heart condition.

Four recent studies have been completed and reviewed by MHRA and the agency reached its conclusion to issue an alert based on their results. The studies were looking for risks of just sudden cardiac death and for both sudden cardiac death and ventricular arrhythmia.

The agency, despite the patient and their risks, recommends prescribing domperidone at the lowest effective dose.

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