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Health Canada Endorsed Important Safety Information on Anzemet (Dolasetron Mesylate)

OTTAWA, CANADA -- July 4, 2006 -- Cases of sustained supraventricular and ventricular arrhythmias, myocardial infarction and one case of fatal cardiac arrest have been reported in association with Anzemet® (dolasetron mesylate) use in both children and adolescents, Health Canada warns.

Since the results of pharmacokinetic studies of Anzemet® indicate a decrease in drug clearance with increasing age, the risk/benefit ratio for the use of Anzemet® in post-operative patients 18 years of age and older is also negative.

The Canadian Anzemet® label has carried warnings about QTc prolongation and the description of serious cardiovascular adverse reactions since approval in 1997. Although Anzemet® has never been indicated for use in children in Canada, Health Canada is aware of the off-label use of this product in the pediatric population. Health Canada is also aware of the off-label use of Anzemet® in adults for the treatment of post-operative nausea and vomiting. Anzemet® is only indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high dose cisplatin, in adults.

Health Canada is requesting all manufacturers of the drugs in this class (5-HT3 antagonists, Anzemet®, Kytril®, and Zofran®) to conduct thorough analyses of their safety databases. Following review of these data, Health Canada will take action as appropriate.

At this time, Health Canada is reminding health care providers to strictly adhere to the dosing recommendations in the Product Monographs of these drugs.

Any suspected adverse reaction can be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
cadrmp@hc-sc.gc.ca

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

For other inquiries related to this communication, please contact Health Canada at:
Bureau of Cardiology, Allergy and Neurological Sciences (BCANS)
E-mail: BCANS_Enquiries@hc-sc.gc.ca
Tel: (613) 941-1499
Fax: (613) 941-1668

Please forward to the relevant Departments (Medical Directors, Intensive Care Units; Directors of Nursing, Intensive Care Units; Director, Department of Pediatrics; Director, Department of Anaesthesiology; Director, Department of Pharmacy, Departments of Oncology, Radio-Oncology, Nuclear Medicine, etc) and involved professional staff and please post this NOTICE.

PRAnzemet® is contraindicated for:
Any therapeutic use in children and adolescents under 18 years of age.
The prevention and treatment of post-operative nausea and vomiting in adults.
These contraindications apply to both intravenous (IV) and oral formulations.


SOURCE: Health Canada

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