What is Avandia?
Avandia is a drug that was approved in 1999 for treatment of type 2 diabetes, a serious and life threatening disease that affects about 18 to 20 million Americans. Diabetes is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation. Since the drug was approved, FDA has been monitoring several heart-related adverse events (e.g., fluid retention, edema and congestive heart failure) based on signals seen in previous controlled clinical trials of Avandia alone and in combination with other drugs, and from postmarketing reports.
FDA Issues Safety Alert on Avandia
The U.S. Food and Drug Administration (FDA) is aware of a potential safety issue related to Avandia (rosiglitazone), a drug approved to treat type 2 diabetes. Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. However, other published and unpublished data from long-term clinical trials of Avandia, including an interim analysis of data from the RECORD trial (a large, ongoing, randomized open label trial) and unpublished reanalysis of data from DREAM (a previously conducted placebo-controlled, randomized trial) provide contradictory evidence about the risks in patients treated with Avandia.
Find the entire report here:
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html
AVANDIA IN THE NEWS
WASHINGTON — The controversy surrounding GlaxoSmithKline's diabetes drug Avandia mounted Wednesday as a medical expert prepared to tell lawmakers executives threatened him with legal action when he first raised questions about the treatment's safety.
Dr. John Buse was contacted by SmithKline Beecham in 1999 after drawing attention to a trend in heart problems among patients using Avandia, according to testimony he was prepared to give a House committee. Buse says the representatives from SmithKline, which combined with GlaxoWellcome in 2000, mentioned that some in the company wanted to hold him accountable for hurting sales of the drug.
Read the article: http://www.foxnews.com/story/0,2933,278576,00.html
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