The Pharmaceutical Journal
Vol 276 No 7389 p222
25 February 2006

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Ximelagatran withdrawn due to liver safety concerns

The oral anticoagulant ximelagatran (Exanta), a direct thrombin inhibitor, has been withdrawn from the market and its development has been terminated, AstraZeneca announced last week.

Ximelagatran is not marketed in the UK but its launch had been expected for some time (PJ, 7 January, p23 PDF (110K)). In several European and South American countries it is licensed and marketed for 11 days’ use for the prevention of venous thromboembolism for patients undergoing elective hip or knee replacement surgery.

Its withdrawal is the result of patient safety data from the EXTEND trial, which examines the prophylactic use of ximelagatran for up to 35 days after orthopaedic surgery.

In a statement, AstraZeneca said: “The new patient report indicates a potential risk of severe liver injury, with an observation of rapid onset of signs and symptoms in the weeks following the end of the 35 days’ treatment.” Supplies will continue for a short time to allow patients to be changed to alternatives.