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New restrictions on the use of rosiglitazone products due to cardiac safety concerns (Avandia, Avandamet, Avandaryl)

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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.
Contact the company for a copy of any references, attachments or enclosures.

Public Communication
Health Canada Endorsed Important Safety Information on rosiglitazone (AVANDIA, AVANDAMET and AVANDARYL)

November 6, 2007

Subject: New restrictions on the use of Avandia^®, AVANDAMET^® and AVANDARYL^TM (rosiglitazone products) due to cardiac safety concerns

GlaxoSmithKline Inc., in consultation with Health Canada, would like to inform you of important new restrictions on which patients with type 2 diabetes can use rosiglitazone-containing products: Avandia^® (rosiglitazone), Avandamet^® (contains both rosiglitazone and metformin), and Avandaryl^TM (contains both rosiglitazone and glimepiride).

Based on a Health Canada review of information available on cardiovascular (heart-related) safety, the consumer and prescriber sections of the official Canadian Product Monographs for rosiglitazone-containing products are being updated and will include the following new usage restrictions:

Rosiglitazone (Avandia^®) is no longer approved for use alone to treat type 2 diabetes, except when metformin* use is contraindicated or not tolerated.
Rosiglitazone is no longer approved for use with a sulfonylurea drug** (such as glyburide), except when metformin is contraindicated or not tolerated.
Rosiglitazone should not be used if you have heart failure, or have experienced heart failure in the past.
Patients who are taking rosiglitazone, especially those with underlying heart disease, or those who are at high risk of heart attack or heart failure, should talk to their doctor about the benefits and risks of continuing rosiglitazone therapy.

* Metformin is an anti-diabetic drug which is sold in Canada as Glucophage, Glumetza or in generic forms with "metformin" as part of the name.
** Drugs that are considered "sulfonylurea drugs" include the following: glyburide (e.g. Diabeta and generic forms of glyburides), glimepiride (Amaryl and generic forms of Glimepiride), gliclazide (Diamicron and generic forms of gliclazide), chlorpropamide (generic forms of Chlorpropamide, Novo-Propamide), and tolbutamide (generic forms of Tolbutamide).

Other important restrictions:

Rosiglitazone should not be taken if you are using insulin.
Rosiglitazone should not be used in 'triple therapy' (triple therapy is therapy with rosiglitazone in combination with both metformin and a sulfonylurea drug).

Combination Use

When adequate blood sugar control is not obtained through diet and exercise plus monotherapy (use of one anti-diabetic agent at a time), then rosiglitazone can be used in combination therapy, as follows:

use in combination with metformin; or
when metformin is contraindicated or not tolerated, use in combination with a sulfonylurea drug.

Rosiglitazone can cause your body to keep extra fluid (fluid retention), which can make some heart problems worse, and lead to heart failure, swelling and weight gain.

If you have questions regarding your current prescription, talk to your doctor or pharmacist.

GSK has sent a letter to Canadian health-care professionals informing them of this new safety information. You may view this letter on the Canadian website of GSK ( www.gsk.ca) or on the website of the Marketed Health Products Directorate of Health Canada.

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. As always, any serious or unexpected adverse reactions in patients receiving Avandia^®, Avandamet^® and Avandaryl^TM 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
www.gsk.ca

Any suspected adverse reaction can be reported to:
Canada Vigilance Program
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
CanadaVigilance@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:
Marketed Health Products Directorate (MHPD)
E-mail: MHPD_DPSC@hc-sc.gc.ca
Tel: 613-954-6522
Fax: 613-952-7738

For media inquiries, please contact GSK Corporate Communications, (905) 819-3363.

Sincerely,

original signed by

Dr. Tjark Reblin, MD, MBA
Vice President, Medical Division and Chief Medical Officer
GlaxoSmithKline Inc.

Avandia^® and Avandamet^® are registered trademarks, used under license by GlaxoSmithKline Inc.; Avandaryl^™ is a trademark, used under license by GlaxoSmithKline Inc.