Domperidone Maleate - Association with Serious Abnormal Heart Rhythms and Sudden Death (Cardiac Arrest) - For Health Professionals
- Starting date:
- January 20, 2015
- Posting date:
- January 20, 2015
- Type of communication:
- Dear Healthcare Professional Letter
- Source of recall:
- Health Canada
- Important Safety Information
- Healthcare Professionals
- Identification number:
This is duplicated text of a letter from Apotex Incorporated, Dominion Pharmacal, Jamp Pharma Corporation, Marcan Pharmaceuticals Inc., Mylan Pharmaceuticals ULC, Pharmascience Inc., Pro Doc Limitée, Ranbaxy Pharmaceuticals Inc., Sanis Health Inc., Sivem Pharmaceuticals ULC and Teva Canada Limited and ratiopharm Inc. Contact the companies for a copy of any references, attachments or enclosures.
Health Canada Endorsed Important Safety Information on domperidone maleate
January 20, 2015
Dear Healthcare Professional:
Subject: Domperidone maleate associated with serious ventricular arrhythmias and sudden cardiac death
The manufacturers of domperidone in collaboration with Health Canada would like to inform you of important additional safety information regarding a small increased risk of serious ventricular arrhythmias or sudden cardiac death in association with domperidone.
Domperidone is indicated in adults for the symptomatic management of upper gastrointestinal motility disorders associated with chronic and subacute gastritis and diabetic gastroparesis. Domperidone is also indicated to prevent gastrointestinal symptoms associated with the use of dopamine agonist antiparkinsonian agents.
A review of epidemiological studies and recent post-market safety data has demonstrated that domperidone exposure was associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death. Based on this new evidence, the labelling of domperidone is being further strengthened to better reflect and address these cardiac risks.
Domperidone may be associated with a small increased risk of serious ventricular arrhythmias or sudden cardiac death. A higher risk was observed in patients:
- older than 60 years of age;
- using daily doses greater than 30 mg;
- having predisposing factors for QT prolongation including concomitant use of QT-prolonging drugs or CYP 3A4 inhibitors.
Domperidone is now contraindicated in patients:
- with prolongation of cardiac conduction intervals, particularly QT;
- with significant electrolyte disturbances;
- with cardiac disease (such as congestive heart failure);
- with moderate or severe liver impairment;
- receiving QT-prolonging drugs and potent CYP3A4 inhibitors.
- Domperidone should be used at the lowest effective dose to a maximum recommended daily dose of 30 mg and for the shortest possible duration.
Domperidone has been marketed in Canada for 30 years. Over this period, Health Canada received 19 Canadian reports of serious cardiac events associated with domperidone.
This safety information applies to all patients using domperidone whatever the condition being treated.
Healthcare professionals should consider doing a cardiac assessment in patients at higher risk for QT interval prolongation and/or cardiac arrhythmia including an electrocardiogram (ECG) prior to initiation of domperidone and during treatment.
Patients should be advised to stop taking domperidone and seek immediate medical attention if they experience signs or symptoms of an abnormal heart rate or rhythm while taking domperidone.
In order to inform on this safety issue, the manufacturers of all domperidone products are modifying the Canadian Product Monographs (CPMs) of the following drugs:
Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious ventricular arrhythmias or sudden cardiac death, or other serious or unexpected adverse reactions in patients receiving domperidone should be reported to the respective manufacturer in the attached list or Health Canada.
- Apotex Incorporated Telephone: 1-800-667-4708 Telefax: 1-416-401-3819
- Dominion Pharmacal Telephone: 1-888-550-6060 Telefax: 1-514-340-0164
- Jamp Pharma Corporation Telephone: 1-866-399-9091 Telefax: 1-450-449-4326
- Marcan Pharmaceuticals Inc. Telephone: (613) 228-2600 ext. 229; Fax: (613) 224-0444
- Mylan Pharmaceuticals ULC Telephone: 1-800-575-1379 Telefax: 1-304-285-6409
- Pharmascience Inc. Telephone: 1-888-550-6060 Telefax : 1-514-340-0164
- Pro Doc Limitée Telephone: 1-800-361-8559 Telefax: 1-450-668-3585 or 1-888-977-6362
- Ranbaxy Pharmaceuticals Inc. Telephone: 1-866-840-1340 Telefax: 1-905-602-4216
- Sanis Health Inc. Telephone: 1-866-236-4076 Telefax: 1-905-689-1465
- Sivem Pharmaceuticals ULC Telephone: 514-832-1286 Telefax: 514-832-1161
- Teva Canada Limited and Ratiopharm Inc. 1-800-268-4127 ext 1255005 (English), 1-877-777-9117 (French), Telefax: 1-416-335-4472
To correct your mailing address or fax number, contact one of the companies listed above.
You can report any suspected adverse reactions associated with the use of health products to Health Canada by:
- Calling toll-free at 1-866-234-2345; or
- Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax
For other health product inquiries related to this communication, contact Health Canada at:
Marketed Health Products Directorate
original signed by:
Colin D'Cunha MBBS, MHSc, FRCPC
Director, Global Medical Affairs,
Len Neirinck, Ph.D.
Vice-President and Chief Scientific Officer,
Pharmascience Inc. and Dominion Pharmacal Inc.
Vice-president, Scientific Affairs
Jamp Pharma Corporation
Sudheer Paladugu, M.Pharm
Vice President - Technical
Marcan Pharmaceuticals Inc.,
Director Regulatory Affairs
Mylan Pharmaceuticals ULC
QC/QA, Regulatory Affairs
Pro Doc Limitée
Director Regulatory Affairs
Ranbaxy Pharmaceuticals Canada Inc.
Director Regulatory Affairs/QA
Sanis Health Inc
Director, Regulatory Affairs and Quality
Sivem Pharmaceuticals ULC
Director, Medical Affairs
Teva Canada Limited