April 24, 2010
The drug Avandia was approved in the U.S. in 1998 for the treatment of type 2 diabetes by controlling blood sugar levels. Millions of diabetics have taken the drug, but in recent years, sales have declined due to reports about an increased risk of potentially life-threatening heart risks. In May 2007, the New England Journal of Medicine published a report on the analysis of 42 clinical trials carried out by GlaxoSmithKline, the manufacturer of Avandia, which suggested that patients using Avandia had a 43% increase risk of heart attack. This article brought wide spread attention to the risk of heart problems for users of Avandia. A recent report by the Senate committee has determined that GlaxoSmithKline knew about the risk that Avandia caused heart problems, but did not inform the FDA. This report also brought to light that some FDA drug safety reviewers have been asking for an Avandia recall since 2007, after their two-year examination of these clinical trial results.
FDA May Recall Avandia:
The FDA had requested that GlaxoSmithKline run a new clinical trial to provide further information about Avandia heart attack risk relative to an alternate drug. More recently, the FDA sent a letter to the Senate indicating that they were considering shutting down this comparative study over concerns about the ethics of continuing the clinical trial. The FDA believed that exposing patients to the potentially dangerous Avandia side effects was unethical. FDA officials have said that canceling this clinical trial cannot be separated from the FDA’s view on the safety of Avandia, suggesting that if the trials are stopped, the FDA may ask GlaxoSmithKline to pull Avandia from the market.
If you have experienced a heart attack or any other heart-related illness while on Avandia you may be entitled to financial compensation for hospital costs, pain and suffering, or lost wages. Avandia class action suits are currently being filed across the country.
AUTHOR:
Susan Ardizzoni, Ph.D. holds a Doctorate in Biology with a major in Neuroscience (medical) and minors in Biochemistry, Physics, and Mathematics with experience in basic and clinical research. Although the author is not an attorney, this article was sponsored by the law firm of Bernstein Liebhard LLP and constitutes Attorney Advertising. To learn more about Avandia lawyer or Avandia class action suits, please visit www.ConsumerInjuryLawyers.com