AstraZeneca takes Exanta anticoagulant off market due to liver damage risk

By Angela McDaniels

Seattle, Feb. 14 - AstraZeneca plc will withdraw its Exanta (melagatran/ximelagatran) anticoagulant from the market and terminate its development, according to a company news release.

AstraZeneca estimated that 400 patients are receiving the drug for short-term prevention of venous thromboembolism following elective hip or knee replacement surgery.

In the weeks following a 35-day clinical trial examining extended use of Exanta, clinicians observed a rapid onset of signs and symptoms indicating severe liver injury.

Liver findings have previously been observed during clinical trials of chronic use, as referred to in the prescribing information, but 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, according to the release.

AstraZeneca said that there is no evidence of a risk of liver injury with approved use up to 11 days, but any unapproved use beyond 11 days is a concern. Therefore, the company has informed regulatory authorities of its decision to withdraw Exanta and is now telling all health care professionals that no new patients should be started on Exanta.

Two ongoing Exanta clinical trials of the drug will be discontinued and Exanta-treated patients will be switched to other treatments. Regulatory files for the drug in United States, Europe and elsewhere will be withdrawn.

AstraZeneca emphasized that patients must not stop Exanta treatment without first consulting their doctor.

"We have decided to take this precautionary action in the interests of patient safety. There are a number of alternative options for short-term post-operative anticoagulation following orthopaedic surgery," chief executive officer David Brennan said in the release.

"Thrombosis is one of the greatest threats to human health and represents a significant public health burden. AstraZeneca remains committed to the discovery and development of new medicines in this area to help improve patients' lives."

Sales of the drug reached $575,000 in 2005, according to the release.

London-based AstraZeneca researches, develops, manufactures and markets prescription pharmaceuticals and supplies health care services.

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