http://www.fileden.com/files/2008/5/6/1899375//Avandia%20-%20HC%20Nov%2018-2010.pdf

AVANDIA® /AVANDAMET®/AVANDARYL® Patient Informed Consent -4- My doctor has recommended one of the following medicines to treat my diabetes (please check one of the boxes below, as appropriate):

â–ˇ AVANDIA® â–ˇ AVANDAMET® â–ˇ AVANDARYL®

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.

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:

AVANDIA®/AVANDAMET®/AVANDARYL® should not be used if I have or have had heart problems.

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.

AVANDIA® /AVANDAMET®/AVANDARYL® Patient Informed Consent -5- 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.

--- In criticalpsychiatry@yahoogroups.com, "bryce_j_j" <jeremybryce1953@...> wrote:
>
>
>
>
> November 18, 2010
>
> Subject: Important new restrictions on the use of rosiglitazone products
> due to information on heart-related events (AVANDIA®, AVANDAMET®
> and AVANDARYL®)
>
> GlaxoSmithKline Inc., in consultation with Health Canada, would like to
> inform you of important new restrictions on the use of AVANDIA®
> (rosiglitazone), AVANDAMET® (contains both rosiglitazone and
> metformin), and AVANDARYL® (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®, 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.
>
> AVANDIA®/AVANDAMET®/AVANDARYL® 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®/AVANDAMET®/AVANDARYL® should
> make an appointment with their doctor as soon as possible to revisit
> their diabetes treatment.
>
> Patients should NOT abruptly stop treatment with
> AVANDIA®/AVANDAMET®/ AVANDARYL® as a result of these new
> restrictions.
>
> Before starting or renewing a prescription for
> AVANDIA®/AVANDAMET®/ AVANDARYL®, doctors will complete the
> PATIENT INFORMED CONSENT PROCESS.
>
> In this process, doctors will:
>
> o Discuss other diabetes treatment options and the benefits and risks of
> AVANDIA®/AVANDAMET®/AVANDARYL® therapy with patients
>
> o Ask patients to read the Consumer Information for AVANDIA®,
> AVANDAMET® or AVANDARYL®
>
> o 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).
>
> -2-
>
> 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®/AVANDAMET®/AVANDARYL® may increase the risk of serious
> heart problems, including:
>
> o heart failure
>
> o angina (chest pain)
>
> o heart attack (myocardial infarction)
>
> o fluid retention (with or without rapid weight gain)
>
> AVANDIA®/AVANDAMET®/AVANDARYL® should not be used if you have
> or have had heart problems.
>
> Before you use AVANDIA®/AVANDAMET®/AVANDARYL®, 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-advisori\
> es-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®/AVANDAMET®/AVANDARYL® and will be asking patients to
> read and sign a form indicating that they understand the heart-related
> risks of AVANDIA®/AVANDAMET®/AVANDARYL®. The informed consent
> form, Product Monographs and Consumer Information for
> AVANDIA®/AVANDAMET®/ AVANDARYL® 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®, AVANDAMET® and
> AVANDARYL® should be reported to GlaxoSmithKline Inc. or Health
> Canada at the following address: -3- 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:
>
> â—¦ Fax toll-free to 1-866-678-6789, or
>
> â—¦ 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: MHPD_DPSC@...
>
> Telephone: 866 234-2345
>
> Fax: 866 678-6789
>