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FDA Rejects Ximelagatran (brand name Exanta)

Henry I. Bussey, Pharm.D.
October 2004

As previously reported on ClotCare, the FDA Cardiovascular and Renal Drugs Advisory Committee recently voted against recommending approval for ximelagatran based on concerns about liver toxicity, the company's proposed system for monitoring liver function tests in patients taking the drug, and the surprise finding of a possible increase in heart attacks with the drug. While the FDA usually follows the recommendation of its advisory panel, many believed that the final decision would not be forthcoming until late in October, 2005. In a press release dated October 11, 2004, however, AstraZeneca has announced that the FDA has decided not to grant approval for the drug. This decision also is being reported on Heartwire, and interestingly, the Heartwire report indicates that the FDA decision was based in part on what may have been three fatalities related to hepatoxicity of the drug. Most earlier information had suggested that the reported increase in liver enzymes were asymptomatic and transient with reversal to normal values occurring even with continuation of the drug.

Links to References & News Coverage

AstraZeneca Press Release

HeartWire

Reuters

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