Avandia
On May 18 of 2011, the FDA informed the public of new restrictions to the prescribing and use of rosiglitazone-containing medicines. These medicines to treat type II diabetes are sold under the names Avandia, Avandamet, and Avandaryl. Healthcare providers and patients must enroll in a special program in order to prescribe and receive these drugs.
On February 3 of 2011, the FDA notified the public about the addition of information concerning the cardiovascular risks, including heart attacks, of taking Avandia, or Rosiglitazone.
Rosiglitazone is sold as a single-ingredient product under the brand name Avandia.
Rosiglitazone is also sold as a combination product under the brand name Avandamet (contains rosiglitazone and metformin) and under the brand name Avandaryl (contains rosiglitazone and glimepiride).
In addition to describing the cardiovascular risks, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:
- In patients already being treated with these medicines
- In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).
At this time, FDA has only approved these safety-related changes to the physician labeling and Medication Guides for the rosiglitazone-containing medicines.
The Risk Evaluation and Mitigation Strategy (REMS), which will restrict rosiglitazone-containing medicines' availability, has not yet been approved and formally implemented.
FDA will be providing further information on this REMS program in the coming months. FDA expects to approve the REMS by Spring 2011, and for the manufacturer to complete implementation 6 months thereafter.
On September 23 of 2010, the U.S. Food and Drug Administration 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.
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