Health Canada, the national drug regulatory agency, has put tight new restrictions on the use of Avandia (rosiglitazone), Avandamet (rosiglitazone and metformin) and Avandaryl (rosiglitazone and glimepiride).
To get a new Avandia prescription, diabetes patients will be required to sign an informed consent form confirming that they have read and understand consumer information about the drug’s heart-related risks and discussed with their physician other diabetes treatment options. In addition, A new boxed warning has been added to the package insert.
The announcement was posted at the Health Canada website on Thursday, November 18, 2010:
AVANDIA, AVANDAMET and AVANDARYL – Important new restrictions on the use of rosiglitazone products due to information on heart-related events – For the PublicAVANDIA, AVANDAMET and AVANDARYL – Important new restrictions on the use of rosiglitazone products due to information on heart-related events – For the Public
Health Canada Endorsed Important Safety Information on AVANDIA, AVANDAMET and AVANDARYL (rosiglitazone)
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:
- Discuss other diabetes treatment options and the benefits and risks of AVANDIA®/AVANDAMET®/AVANDARYL® therapy with patients
- Ask patients to read the Consumer Information for AVANDIA®, AVANDAMET® or AVANDARYL®
- 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).
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:
GSK has sent a letter to Canadian healthcare professionals informing them of this new safety information. You may view this letter on the Canadian Web site of GSK or on Health Canada’s MedEffect Web site.
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 on the Canadian Web site of GSK. The Product Monographs will also be available on Health Canada’s Drug Product Database.