PUBLIC COMMUNICATION - Health Canada Endorsed Information on Important New
Restrictions on the use of rosiglitazone (PrAVANDIA(R), PrAVANDAMET(R) and
PrAVANDARYL(R))
Subject: Important new restrictions on the use of rosiglitazone products
due to information on heart-related events (AVANDIA(R),
AVANDAMET(R) and AVANDARYL(R))
MISSISSAUGA, ON, Nov. 18 /CNW/ - GlaxoSmithKline Inc., in consultation with Health Canada, would like to inform you of important new restrictions on the use of AVANDIA(R) (rosiglitazone), AVANDAMET(R) (contains both rosiglitazone and metformin), and AVANDARYL(R) (contains both rosiglitazone and glimepiride) for the treatment of type 2 diabetes mellitus.
Based on a Health Canada review of recent data suggesting an elevated risk of cardiovascular (heart-related) events in patients treated with AVANDIA(R), the consumer and prescriber sections of the Canadian Product Monographs for rosiglitazone-containing products have been updated and include new usage restrictions. These restrictions and important information for patients are described below.
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AVANDIA(R)/AVANDAMET(R)/AVANDARYL(R) is now indicated only in patients
with type 2 diabetes mellitus when all other diabetes medicines taken
orally (by mouth) have not lowered blood sugar enough, or are not
appropriate.
- Patients currently taking AVANDIA(R)/AVANDAMET(R)/AVANDARYL(R) should
make an appointment with their doctor as soon as possible to revisit
their diabetes treatment.
- Patients should NOT abruptly stop treatment with AVANDIA(R)/AVANDAMET
(R)/ AVANDARYL(R) as a result of these new restrictions.
- Before starting or renewing a prescription for AVANDIA(R)/AVANDAMET
(R)/ AVANDARYL(R), doctors will complete the PATIENT INFORMED CONSENT
PROCESS. In this process, doctors will:
- Discuss other diabetes treatment options and the benefits and
risks of AVANDIA(R)/AVANDAMET(R)/AVANDARYL(R) therapy with
patients
- Ask patients to read the Consumer Information for AVANDIA(R),
AVANDAMET(R) or AVANDARYL(R)
- Ask patients to read and sign a form (see Informed Consent Form at
the end of this Public Communication) indicating that the patient
understands the heart- related risks of the medication and has
discussed other options to treat their diabetes with their doctor
(Consumer Information and Informed Consent Form are also available
electronically, See Below).
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Also please note that a new boxed warning has been added to the Canadian Product Monographs. In the Consumer Information section, this boxed warning includes the following information:
- AVANDIA(R)/AVANDAMET(R)/AVANDARYL(R) may increase the risk of serious
heart problems, including:
- heart failure
- angina (chest pain)
- heart attack (myocardial infarction)
- fluid retention (with or without rapid weight gain)
- AVANDIA(R)/AVANDAMET(R)/AVANDARYL(R) should not be used if you have
or have had heart problems.
- Before you use AVANDIA(R)/AVANDAMET(R)/AVANDARYL(R), talk to your
doctor about other options to treat your diabetes.
GSK has sent a letter to Canadian healthcare professionals informing them of this new safety information. You may view this letter on the Canadian website of GSK (www.gsk.ca) or on Health Canada's MedEffect website (http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/new-neuf-advisories-avis-eng.php)
Doctors have been advised to counsel new and currently treated patients on the risks and benefits of starting and/or continuing treatment with AVANDIA(R)/AVANDAMET(R)/AVANDARYL(R) and will be asking patients to read and sign a form indicating that they understand the heart-related risks of AVANDIA(R)/AVANDAMET(R)/AVANDARYL(R). The informed consent form, Product Monographs and Consumer Information for AVANDIA(R)/AVANDAMET(R)/ AVANDARYL(R) are available at www.gsk.ca. The Product Monographs will also be available on Health Canada's Drug Product Database (http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/index-eng.php).
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(R), AVANDAMET(R) and AVANDARYL(R) should be reported to GlaxoSmithKline Inc. or Health Canada at the following address:
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GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Tel.: 1-800-387-7374
www.gsk.ca
You can report any suspected adverse reactions associated with the use of
health products to the Canada Vigilance Program by one of the following 3
ways:
- Report online at www.healthcanada.gc.ca/medeffect
- 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 MedEffectTM Canada Web site in the Adverse Reaction Reporting section
(http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php).
The Reporting Form is also in the Canadian Compendium of Pharmaceuticals
and Specialties.
For other health product inquiries related to this communication, please
contact Health Canada at:
Canada Vigilance National Office
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
E-mail: [email protected]
Telephone: 866 234-2345
Fax: 866 678-6789
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For media enquiries, please contact GSK Corporate Communications, (905) 819-3363.
Avandia(R), Avandamet(R) and Avandaryl(R) are registered trademarks, used under license by GlaxoSmithKline Inc.
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AVANDIA(R) /AVANDAMET(R)/AVANDARYL(R)
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(R)
AVANDAMET(R)
AVANDARYL(R)
Please read this Patient Informed Consent ("Consent") and the individual Consumer Information for AVANDIA(R)/AVANDAMET(R)/AVANDARYL(R) and discuss any questions or concerns with your doctor before you sign this Consent.
Do not sign this Consent and do not take AVANDIA(R)/AVANDAMET(R)/AVANDARYL(R) if there is anything you do not understand about the information you have received.
I am aware that:
- AVANDIA(R)/AVANDAMET(R)/AVANDARYL(R) 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(R) and one of the
active ingredients in AVANDAMET(R) and AVANDARYL(R), 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(R)/AVANDAMET(R)/AVANDARYL(R) 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(R)/AVANDAMET
(R)/AVANDARYL(R) that are outlined in the individual Consumer
Information for AVANDIA(R)/ AVANDAMET(R)/AVANDARYL(R) 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(R)/AVANDAMET(R)/
AVANDARYL(R), 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(R)/AVANDAMET(R)/AVANDARYL(R) carefully, and to discuss it with my doctor. I now authorize my doctor to continue/begin my treatment with AVANDIA(R)/AVANDAMET(R)/AVANDARYL(R).
Patient or Legally Appointed Guardian signature lines are below. AVANDIA(R)/ AVANDAMET(R)/AVANDARYL(R) are not recommended for use in people under the age of 18.
Patient (and Legally Appointed Guardian if applicable) Name(s)
Please Print:
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Patient / Legally Appointed Guardian Signature:
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Date
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(R) AVANDIA, AVANDAMET, and AVANDARYL are registered trademarks, used under license by GlaxoSmithKline Inc.
For further information: GlaxoSmithKline Inc., 7333 Mississauga Road, Mississauga, Ontario, L5N 6L4, Tel.: 1-800-387-7374, www.gsk.ca
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