Ximelagatran (Exanta™), made by AstraZeneca, has been withdrawn from the worldwide market following new patient safety data and a report of serious liver damage.
Currently, ximelagatran is sold in Germany, Portugal, Sweden, Finland, Norway, Iceland, Austria, Denmark, France, Switzerland, Argentina and Brazil. It has also been approved, but was not put on the market, in Belgium, Spain, The Netherlands, Luxembourg, Greece, Indonesia, Hong Kong, Italy, Russia and Ukraine.
"This specific observation has not previously been made in relation to Exanta and indicates that regular liver function monitoring may not mitigate the possible risk... Therefore, in the interests of patient safety, AstraZeneca is taking the precautionary measure of withdrawing Exanta, " said AstraZeneca in a press release.
The company will halt two ongoing trials of the drug and "regulatory files in orthopedic surgery and other indications in the US, Europe, and elsewhere will now be withdrawn."
For patients currently on ximelagatran, "doctors should consider changing treatment to an alternative anticoagulant while taking account of individual patient circumstances and ensuring uninterrupted anticoagulation," the company statement said.
Reference
'AstraZeneca decides to withdraw Exanta™' AstraZeneca press release, 14th February 2006.
Press release