Safety Alerts & Recalls

What does this mean?

If you are a patient currently taking Avandia, Avandamet, or Avandaryl, you should continue taking your medication and consult your healthcare professional. With the advice and guidance from your healthcare professional, you may choose to select an alternative medication to treat your diabetes. It is very important that you continue on a treatment that controls your blood sugar.

The Avandia restricted access program does not immediately take effect. It will take several months to put the program in place. Once the program is in place, current users of Avandia products will only be able to continue using the medication if they acknowledge and document that they understand the risks associated with the drug. The FDA will provide further information on the restricted access program in the coming months.

Avandia: Restricted Access Program To Be Developed

Today, the U.S. Food and Drug Administration (FDA) announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.

The FDA will require that manufacturer GlaxoSmithKline develop a restricted access program for Avandia. Under this program, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so.

Avandia contains the active ingredient rosiglitazone. Rosiglitazone also is available in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.

To view the FDA's Avandia questions and answers web page, please visit: more information here

To view links to all Avandia related information from the FDA, please visit: more information here

Source: FDA
Publication Date: 2010-09-23
Last Updated: 2010-09-23

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