FDA approves new warning labels for diabetes drugs Avandia, Avandament
The Food and Drug Administration (FDA) has approved the new safety information for physicians and patients for the type 2 diabetes drug Avandia (rosiglitazone). The new safety information was required by the FDA last September, when the agency voted to severely restrict the drug based on studies that showed Avandia put users at greater risk of cardiovascular events such as heart attack and stroke. The drug has been suspended from the European market based on the same concerns.
In order for Americans to continue to use rosiglitazone, their doctors must attest to and document their eligibility, and patients will have to review statements describing the cardiovascular safety concerns with rosiglitazone and acknowledge that they understand the risks. Studies suggest that as many as 100,000 heart attacks may have been caused by rosiglitazone.
The new labels also state that the drug should only be used in patients already being treated with rosiglitazone, in patients whose blood sugar cannot be controlled with other anti-diabetic medications, and who, after consulting with their health care professional, do not wish to use pioglitazone-containing medications, another type of diabetes drug that includes the brands Actos, Actoplus Met, Actoplus Met XR, or Duetact.
Rosiglitazone is sold as a single-ingredient product under the name Avandia. It is also sold as a combination product under the brand name Avandament (rosiglitazone and metformin) and the brand name Avandaryl (rosiglitazone and glimepride).
Sales of rosiglitazone-containing drugs experienced a $3.2 billion sales volume in 2006. Cardiovascular concerns surrounding the drug caused sales to dip to just more than $2 billion in 2009. The FDA anticipates the new restrictions will have a devastating impact on future sales of rosiglitazone.
AVANDIA is a registered trademark of GlaxoSmithKline.
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