Ximelagatran - Side-effects

Side-effects

Ximelagatran was generally well tolerated in the trial populations, but a small proportion (5-6%) developed elevated liver enzyme levels, which prompted the FDA to reject an initial application for approval in 2004. The further development was discontinued in 2006 after it turned out hepatic damage could develop in the period subsequent to withdrawal of the drug. According to AstraZeneca, a chemically different but pharmacologically similar substance, AZD0837, is undergoing testing for similar indications. In a study of deep-vein thrombosis comparing the effectiveness of ximelagatran, with that of a combination of enoxaparin and warfarin, the rate of serious coronary events associated with ximelagatran was 0.81%, versus 0.08% for the latter (P=0.006)

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