FDA Warned Drug Maker of Avandia Dangers
May 25, 2007 -- The maker of the popular diabetes drug Avandia received written warnings about the drug's risks more than five years before a medical study released this week revealed a link between Avandia and an increase in heart disease and fatal heart attacks.
The disclosures by the U.S. Food and Drug Administration about previous warnings regarding Avandia's links to heart problems raise questions about whether the drug maker, GlaxoSmithKline, exhibited a pattern of downplaying the drug's risks.
In one March 2000 letter to the FDA about Avandia, diabetes researcher Dr. John Buse raised concerns about "rampant abuse of clinical trial data" by Avandia's maker SmithKline Beecham(now known as GlaxoSmithKline).
"I believe that they have overstated the safety of the drug with respect to cardiovascular issues,"" Dr. Buse wrote, adding that he detected "something pervasive and systematic" about the drugmaker's marketing that exaggerated the safety claims of the drug.
A year later, the FDA sent GlaxoSmithKline a warning that its marketing and advertising for Avandia was false and misleading. The warning specifically focused on statements by GlaxoSmithKline representatives and promotional materials that failed to disclose risk information about the drug.
A clinical study by the prestigious Cleveland Clinic published this week in the New England Journal of Medicine, concluded that Avandia increased the chances of heart attack by 43 percent and increased the chances of cardiac-related death by 64 percent.
Released in 1999, Avandia (rosiglitazone) has become the world's top-selling diabetes drug and is currently used by about one million Americans. The Cleveland Clinic study prompted the FDA to release a new warning about Avandia on May 21, 2007. The Safety Alert warned patients taking the drug to talk with their doctor about the risks.
If you or a loved one has taken Avandia and suffered side effects, please contact our office for a free evaluation.
