Avandia Subject to Restrictions in Canada

Health Canada just announced important new restrictions on the use of the following rosiglitazone products due to information on cardiovascular related events: <"http://www.yourlawyer.com/topics/overview/Avandia-Heart-Attack-Lawsuit-Lawyer-Attorney-Heart-Failure">Avandia, Avandamet and Avandaryl.

GlaxoSmithKline Inc., in consultation with Health Canada, released important new restrictions on the use of <"http://www.yourlawyer.com/topics/overview/Avandia-Heart-Attack-Lawsuit-Lawyer-Attorney-Heart-Failure">Avandia (rosiglitazone), Avandamet (rosiglitazone and metformin), and Avandaryl (rosiglitazone and glimepiride) for the treatment of type 2 diabetes mellitus.

Following Health Canada’s assessment of recent data collected from a meta-analysis of clinical trials and from some observational studies suggesting an elevated risk of cardiovascular events in patients treated with Avandia there are new usage restrictions on rosiglitazone-containing products. Effective immediately, Avandia, Avandamet and Avandaryl are now indicated only in patients with type 2 diabetes mellitus for whom all other oral anti-diabetic agents, in monotherapy or in combination, do not provide adequate glycemic control or are inappropriate due to contraindications or intolerance.

Prior to starting or renewing a prescription for Avandia, Avandamet or 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 revised criteria;

• Counsel each patient on the risks and benefits of Avandia, Avandamet or Avandaryl, including the cardiovascular risks; and

• Obtain the patient’s written informed consent to take the medication.

In Canada, product monographs have been updated and new boxed warnings have been added indicating:

• 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 or Avandaryl are 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 anti-diabetic 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 existing patients about the risks of initiating and/or continuing rosiglitazone therapy and obtain their written informed consent. Copies of the informed consent and consumer information for Avandia, Avandamet and Avandaryl are available at the Canadian GSK website at: http://www.gsk.ca/english/index.html or by contacting GSK Customer Service, toll-free, at 1-800-387-7374.

Pharmacists can continue to dispense Avandia, Avandamet and Avandaryl to patients and should refer patients to their physicians for advice on 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.

For help with legal claims involving Avandia, please visit <"http://www.yourlawyer.com/topics/overview/avandia">www.yourlawyer.com.

This entry was posted in Avandia, Pharmaceuticals. Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.