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Reports of heart problems linked to the diabetes drug Avandia soared after the May 21 publication of an analysis describing potential cardiovascular risks of Avandia treatment. The study, released by The New England Journal of Medicine, has caused a furor over both Avandia's risks and the issue of whether the U.S. Food and Drug Administration (FDA) is doing enough to protect consumers from dangerous drugs.
Physicians Connecting the Dots
The sharp increase is thought to be due to physicians' new awareness that their patients' heart problems may be due to Avandia use. As Vanderbilt University diabetes specialist Dr. Alvin C. Powers noted, "Now, patients and their doctors are much more aware of the possible link between Avandia and cardiovascular disease. This is going to help us going forward to determine whether or not this drug is safe."
Fifty reports of adverse events linked to Avandia were made to the FDA in January 2007, and 73 in February. From mid-April to May 21, when the new study was published, 121 such events were reported, including 11 Avandia-linked deaths. In the 35 days after the study's publication, 357 adverse event reports were received by the FDA, with 38 deaths linked to Avandia.
Congressional Involvement
Avandia is used to treat type 2 diabetes in six million people around the world. Its maker, GlaxoSmithKline, has been accused of minimizing the information about cardiovascular risks of the drug, including heart attack and stroke.
The FDA has scheduled a July 30 hearing regarding Avandia's potential risks, and members of Congress have included the Avandia controversy in their criticism of the FDA's performance. Critics allege that the FDA's oversight of new drugs is flawed, and that a better safety tracking system is necessary to protect American healthcare consumers.
(Source: The Washington Post online)
Has Avandia treatment harmed you or a member of your family? Contact a qualified Avandia attorney today to discuss your concerns. You may be eligible for monetary compensation for damages caused by Avandia.