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As a subscriber you can listen to articles at work, in the car, or while you work out. Subscribe NowConsumer health advocates and a patent holder on a highly anticipated blood thinner from Eli Lilly and Co. want the U.S. Food and Drug Administration to halt its review of the drug, which they say may be unsafe at the suggested dose.
The FDA has been reviewing Indianapolis-based Lilly’s prasugrel since January 2008. A company study showed the drug prevents more heart attacks than an older drug, but also causes more internal bleeding.
Consumer watchdog Public Citizen, a Washington, D.C.-based not-for-profit, and Dr. Victor Serebruany, a research professor who holds a patent on the drug, contend that the dose used in that study led to the excess bleeding. They ask the agency to halt its review until new studies are completed.
Lilly wants to pit prasugrel head-to-head against the current best-selling blood thinner, Plavix, which brings in $8.5 billion in annual sales for Bristol-Myers Squibb Co. and Sanofi-Aventis SA.
Lilly has already won approval to sell prasugrel in Europe earlier this year. The drug initially is being used, in combination with aspirin, to treat patients who are having their arteries propped open and have already been diagnosed with various heart conditions.
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