McNeil Products Ltd. and Winthrop Pharmaceuticals UK Ltd (trading as Zentiva- a Sanofi company) have issued new information regarding cardiac risks of domperidone products (Motilium® and all available generic products). This follows findings from some epidemiological studies that domperidone may be associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death; and these risks may be higher in patients older than 60 years and in patients who receive daily oral doses of more than 30 mg. The communication contains the following advice:

• Domperidone should be used at the lowest effective dose in adults and children.

• Patients should be advised to seek prompt medical attention if symptoms such as syncope or tachyarrhythmia appear during treatment.

• Domperidone should be avoided in patients who are taking concomitant medication known to cause QT prolongation (such as ketoconazole and erythromycin).

• Non-prescription domperidone products - sold under the supervision of a pharmacist (P legal status) - should not be supplied to patients with underlying cardiac disease.

• The benefits of domperidone continue to outweigh the risks.

Healthcare professionals are also advised to be particularly cautious when treating patients who have: existing prolongation of cardiac conduction intervals (particularly QTc); significant electrolyte disturbances; or underlying cardiac diseases such as congestive heart failure. The product information for domperidone is being updated to reflect these data.