This information was sent to every pharmacist and doctor in the UK in December. As a pharmacist with prescribing rights it would make me think very carefully about prescribing more than 10mg three times a day.

Wendy Jones

Pharmacist with a special interest in drugs in breastmilk in UK

www.breastfeeding-and-medication.co.uk
www.breastfeedingnetwork.org.uk

Forwarded;
McNeil Products Ltd. and Winthrop Pharmaceuticals UK Ltd (Trading as Zentiva- a Sanofi company) would like to inform you of new information regarding cardiac risks of domperidone products (Motilium® and all available generic products). 

Summary 

 Some epidemiological studies have shown that domperidone may be associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death. 

 These risks may be higher in patients older than 60 years and in patients who receive daily oral doses of more than 30 mg. 

 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. 

In 2010, two new epidemiological studies [1,2] were published in the scientific literature concerning the risk of ventricular arrhythmia or sudden cardiac death and a possible association with domperidone. A weak association with sudden cardiac death was found. It was concluded that there is some evidence to support that particularly at higher doses (>30mg/day) or in patients older than 60 years, domperidone may be associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death. 

Healthcare professionals should be aware of these risks and 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. 

1 Van Noord C. et al. Drug Saf 2010; 33 (11): 1003-1014 

2 Johannes C. et al. Pharmacoepidemiology and Drug Safety 2010; 19:881-888 


From: LACTNET automatic digest system 
Sent: Sunday, March 04, 2012 5:00 AM
To: [log in to unmask] 
Subject: LACTNET Digest - 3 Mar 2012 (#2012-186)


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