Nine months ago, the drug company Glaxo-SmithKline posted a study along with dozens of others on an obscure company website.The study indicated that the company's blockbuster diabetes drug, Avandia, raised patients' heart disease risk by 30%. At about the same time, company officials say, they told the Food and Drug Administration what they had found.
That apparently wasn't the first time Glaxo warned the agency about its drug. FDA's Susan Cruzan confirmed Monday that the company had warned the agency of a potential safety problem at least as early as 2005.
Yet neither the company nor the FDA took additional steps to warn the public until Monday, when a fast-tracked study released on the Internet by a major medical journal prompted the agency to issue a Safety Alert warning of a "potentially significant" excess risk of heart attack and heart-related deaths.
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