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Cardiac safety of PrAVANDIA® (rosiglitazone maleate)
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(PDF Version - 437 K)Contact: Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS)
The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from GlaxoSmithKline Inc. (GSK).
Contact the company for a copy of any references, attachments or enclosures.
Public Communication
Health Canada Endorsed Important Safety Information on
PrAvandia®, PrAvandamet® and PrAvandaryl™
May 30 , 2007
Subject: Cardiac Safety of PrAvandia® (rosiglitazone maleate)
Mississauga, Ontario [May 30, 2007] - GlaxoSmithKline Inc (GSK), in conjunction with Health Canada, would like to address public concerns about the safety of Avandia®.
An article recently published in the New England Journal of Medicine (NEJM) has raised concern about an increased risk of myocardial infarction (heart attack) and cardiovascular death in patients with type 2 diabetes treated with Avandia®. This article was based on a review of 42 clinical studies. The conclusions reached require confirmation. Further investigation of these results is underway and more information will be communicated when available.
Some of the studies in the NEJM article included patients using Avandia®, in combination with other diabetic treatments. Some of these combinations are not approved for use in Canada.
In Canada, Avandia® is approved when diet, weight loss, and exercise are not enough to control diabetes. Avandia® may be used alone or in combination with other diabetes medications called metformin or a sulfonylurea.
Avandia® is not approved for use with insulin therapy or for use with the combination of metformin with a sulfonylurea.
- Do not stop taking Avandia® without first consulting your healthcare provider. Lack of control of blood sugar levels can cause serious medical problems.
Patients who are taking Avandia®, especially those with underlying heart disease, mild to moderate heart failure or those who are at high risk of heart attack, should talk to their doctor.
- Avandia® should not be used if you have heart problems. Avandia® can cause your body to keep extra fluid (fluid retention), which leads to swelling and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure.
Healthcare professionals thoroughly consider the overall benefit versus the risk of a medication for each individual patient before prescribing. If patients have questions regarding their current prescription, they are asked to contact their doctor or pharmacist.
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. Please be reminded that any serious or unexpected adverse reactions in patients receiving Avandia® should be reported to GlaxoSmithKline or Health Canada at the following addresses:
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Tel.: 1-800-387-7374
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 Metabolism, Oncology and Reproductive Sciences (BMORS)
E-mail: bmors_enquiries@hc-sc.gc.ca
Tel: 613-941-3171
Fax: 613-941-1365
For media inquiries, please contact GSK Corporate Communications, (905) 819-3363.
Sincerely,
original signed by
Ravinder Kumar, Ph.D.
Vice President, Regulatory Affairs
GlaxoSmithKline Inc.
Avandamet® and Avandaryl™, contain the same active ingredient as Avandia®.
Avandia® and Avandamet® are registered trademarks, used under license by GlaxoSmithKline Inc.
Avandaryl™ is a trademark, used under license by GlaxoSmithKline Inc.
