FDA Receives More Reports of Avandia® Side Effects
WASHINGTON, DC -- July 20, 2007 -- The Food and Drug Administration (FDA) has seen a sharp increase in reports of heart attacks among patients who use the diabetes drug, Avandia®, since a medical journal article connected the drug to heart problems. There were 90 heart attacks among Avandia® users from May 21, 2007, the date of publication, through July 12, according to Associated Press news reports obtained through the Freedom of Information Act. However, there were only 5 heart attacks reported among Avandia® users in the 35 days prior to May 21.
The increase in heart attack reports may be due to doctors becoming more aware of the link between Avandia® and coronary problems. Prior to the article's publication, doctors may not have made the connection between the diabetes drug and heart attacks, and therefore would be less likely to report these events.
Some experts say that the emerging news about serious Avandia® side effects points out the flaws in the current FDA reporting system. Doctors are not required to inform the FDA about their patients' adverse reactions to a medication. Rather, their reports are purely voluntary. To make matters worse, some medications go on the market before they are adequately tested. After enough patients fall ill, the defective drugs may get pulled from the market. The most notable instance of the FDA's failure to safeguard the public is its handling of Vioxx®, an arthritis drug associated with heart attacks and strokes that was finally recalled in September 2004.
Warnings and Hearings on Avandia®
The FDA approved Avandia® (generic name, rosiglitazone) in 1999 to lower blood sugar levels in patients with type 2 diabetes. Before Avandia® was approved, an FDA medical reviewer had warned that the drug could cause heart problems and suggested a post-marketing study. Although a post-marketing study was done, its purpose was to consider how well Avandia® controlled blood sugar levels, not whether it increased heart attack risks. In March 2000, Dr. John Buse, a director of the Diabetes Care Center at the University of North Carolina School of Medicine, sent letters to the FDA and SmithKline Beecham, Avandia®'s manufacturer, warning about the drug's potential for heart problems and requesting further studies.
On May 23, 2007, two days after the headline-making Avandia® article was published, the FDA requested that a "black box" warning be added to Avandia®'s prescribing instructions about the increased risk of congestive heart failure. A black box warning is the strongest alert that can be given for a drug, short of taking it off the market.
Last month, the House Oversight and Government Reform Committee met to discuss Avandia®'s safety and whether the FDA was properly monitoring the drug. The FDA plans to hold new hearings about Avandia®'s side effects on July 30.