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Health professional risk communication

AVANDIA, AVANDAMET and AVANDARYL - Important New Restrictions on the Use of Rosiglitazone Products Due to Information on Cardiovascular Related Events - For Health Professionals

Starting date:
November 9, 2010
Posting date:
November 18, 2010
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Audience:
Healthcare Professionals
Identification number:
RA-170002213

This is duplicated text of a letter from GlaxoSmithKline Inc.
Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important New Restrictions on the use of rosiglitazone (AVANDIA, AVANDAMET and AVANDARYL)

November 9, 2010

Subject: Important new restrictions on the use of rosiglitazone products due to information on cardiovascular related events (AVANDIA®, AVANDAMET® and AVANDARYL®)

Dear Health Care Professional,

GlaxoSmithKline Inc., in consultation with Health Canada, would like to inform you of important new restrictions on the use of AVANDIA® (rosiglitazone), AVANDAMET® (rosiglitazone and metformin), and AVANDARYL® (rosiglitazone and glimepiride) for the treatment of type 2 diabetes mellitus.

Further to a Health Canada assessment of recent data collected from a meta-analysis of clinical trialsFootnote1 and from some observational studiesFootnote 2, Footnote3 suggesting an elevated risk of cardiovascular events in patients treated with AVANDIA®, there are new usage restrictions on rosiglitazone-containing products, as follows:

AVANDIA®/Avandamet®/AVANDARYL® is now indicated only in patients with type 2 diabetes mellitus for whom all other oral antidiabetic agents, in monotherapy or in combination, do not result in adequate glycemic control or are inappropriate due to contraindications or intolerance.

Prior to starting or renewing a prescription for AVANDIA®/AVANDAMET®/AVANDARYL®, physicians should consider whether a rosiglitazone-containing product is an appropriate therapeutic choice, and if so:

  • Document the eligibility of patients to meet the above criteria;
  • Counsel each patient on the risks and benefits of AVANDIA®/AVANDAMET®/AVANDARYL®, including the cardiovascular risks; and
  • Obtain the patient's written informed consent to take the drug (see attached).

The Canadian Product Monographs for rosiglitazone-containing products have been updated to reflect the new indication and informed consent process. Also, note that a new boxed warning has been added to the Canadian Product Monographs with the following information:

  • Rosiglitazone-containing products, like other thiazolidinediones, can cause fluid retention and congestive heart failure.
  • Rosiglitazone-containing products may be associated with an increased risk of cardiac ischemia. AVANDIA®/AVANDAMET®/AVANDARYL® is not recommended in patients with a history of ischemic heart disease, particularly those with myocardial ischemic symptoms.
  • Rosiglitazone-containing products should be used only when all other oral antidiabetic agents, in monotherapy or in combination, do not result in adequate glycemic control or are inappropriate due to contraindications or intolerance.

Physicians are advised to counsel new and currently treated patients about the risks of initiating and/or continuing rosiglitazone therapy and obtain their written informed consent as described above. Copies of the informed consent and consumer information for AVANDIA®, AVANDAMET® and AVANDARYL® are attached and will be available on the Canadian Web site of GSK, or may be ordered by contacting GSK Customer Service at 1-800-387-7374.

Pharmacists can continue to dispense AVANDIA®, AVANDAMET® and AVANDARYL® to patients and should refer patients to their physician for advice on their treatment.

A Public Communication will be issued to inform patients about these changes, and will advise patients to make an appointment with their doctor as soon as possible to revisit their treatment, rather than abruptly stopping their medication.

The Product Monographs for AVANDIA®, AVANDAMET® and AVANDARYL® will also include additional cardiovascular information and once available will replace the versions dated March 2009 (AVANDIA® and AVANDAMET®) and May 2009 (AVANDARYL®). The revised Product Monographs for AVANDIA®, AVANDAMET® and AVANDARYL® will be available on the Canadian Web site of GSK and Health Canada's Drug Product Database.

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 or unexpected adverse reactions in patients receiving AVANDIA®, AVANDAMET® and AVANDARYL® should be reported to GlaxoSmithKline Inc. or Health Canada at the following addresses:

GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Telephone: 1-800-387-7374

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

  • Report online at MedEffect™ Canada Web site
  • Call toll-free at 1-866-234-2345
  • Complete a Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa, Ontario  K1A 0K9

The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffect™ Canada Web site in the Adverse Reaction Reporting section.

For other health product inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: MHPD_DPSC@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

To change your mailing address or fax number, contact the Market Authorization Holder (Industry).

Your professional commitment in this regard has an important role in protecting the well-being of your patients by contributing to early signal detection and informed drug use.

Any questions from health care professionals may be directed to our Medical Information department via GSK Customer Service at 1-800-387-7374.

Sincerely,

original signed by

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

AVANDIA®, AVANDAMET® and AVANDARYL® are registered trademarks, used under license by GlaxoSmithKline Inc.

Attachments: Informed Consent and Consumer Information for AVANDIA®, AVANDAMET® and AVANDARYL®

This HTML document is not a form. Its purpose is to display the information as found on the form for viewing purposes only. If you wish to use the form, you must use the alternate format below.

[NJS_FILE:6e5a40a6-dfcc-4841-89fd-157b05f7a8d6:702cd6e0-d85a-4281-855e-f62292b4bec6]

AVANDIA®/AVANDAMET®/AVANDARYL®
Patient Informed Consent

My doctor has recommended one of the following medicines to treat my diabetes (please check one of the boxes below, as appropriate):

  • AVANDIA®
  • AVANDAMET®
  • AVANDARYL®

Please read this Patient Informed Consent ("Consent") and the individual Consumer Information for AVANDIA®/AVANDAMET®/AVANDARYL® and discuss any questions or concerns with your doctor before you sign this Consent.

Do not sign this Consent and do not take AVANDIA®/AVANDAMET®/AVANDARYL® if there is anything you do not understand about the information you have received.

I am aware that:

  • AVANDIA®/AVANDAMET®/AVANDARYL® are medicines used in addition to diet and exercise to lower blood sugar in people with type 2 diabetes when all other diabetes medicines taken orally (by mouth), either alone or in combinations, have not lowered blood sugar enough or are not appropriate.
  • Rosiglitazone, the active ingredient in AVANDIA® and one of the active ingredients in AVANDAMET® and AVANDARYL®, may increase the risk of serious heart problems, including:
    • heart failure
    • angina (chest pain)
    • heart attack (myocardial infarction)
    • fluid retention (with or without weight gain)
  • AVANDIA®/AVANDAMET®/AVANDARYL® should not be used if I have or have had heart problems.
  • There are other options to treat my diabetes, as explained by my doctor.
  • There are other risks associated with AVANDIA®/AVANDAMET®/AVANDARYL® that are outlined in the individual Consumer Information for AVANDIA®/AVANDAMET®/AVANDARYL® and I have been given the opportunity to ask and discuss any questions or concerns about those risks with my doctor.
  • I understand that in order to be prescribed AVANDIA®/AVANDAMET®/AVANDARYL®, I am required to sign this Consent.

My doctor has explained the above to me, I have been given time to read this Consent and the individual Consumer Information for AVANDIA®/AVANDAMET®/AVANDARYL® carefully, and to discuss it with my doctor. I now authorize my doctor to continue/begin my treatment with AVANDIA®/AVANDAMET®/AVANDARYL®.

Patient or Legally Appointed Guardian signature lines are below. AVANDIA®/AVANDAMET®/AVANDARYL® are not recommended for use in people under the age of 18.

Patient (and Legally Appointed Guardian if applicable) Name(s)

Please Print:

Patient / Legally Appointed Guardian Signature:

Date:

® AVANDIA, AVANDAMET, and AVANDARYL are registered trademarks, used under license by GlaxoSmithKline Inc.

References:

Footnote 1

Nissen S, Wolski K. Rosiglitazone Revisited. An Updated Meta-analysis of Risk for Myocardial Infarction and Cardiovascular Mortality. Arch Intern Med 2010; 170 (14). 1191-1201.

Return to footnote 1 referrer

Footnote 2

Juurlink D, Gomes T, Lipscombe L, Austin P, Hux J, Mamdani M. Adverse Cardiovascular Events during treatment with pioglitazone and rosiglitazone: population based cohort study. BMJ 2009; 339:b2942.

Return to footnote 2 referrer

Footnote 3

Graham DJ, Quellet-Hellstrom R, MaCurdy TE et al. Risk of Acute Myocardial Infarction, Stroke, Heart Failure, and Death in Elderly Medicare Patients Treated With Rosiglitazone or Pioglitazone. JAMA 2010;304:411-418.

Return to footnote 3 referrer