AstraZeneca withdraws Exanta as drug is linked to risk of severe liver injury

Anglo-Swedish drug major AstraZeneca says that it has decided to withdraw its anticoagulant Exanta (melagatran /ximelagatran) from the market due to concerns that the drug may cause liver injury. The firm estimates that 400 patients are currently taking the compound for the prevention of venous thromboembolism after orthopedic surgery.

The decision to remove the product from the market was brought about by analysis of new patient safety data from the EXTENT trial program, which examined the compound as a prophylactic treatment for VTE post surgery. The new patient report indicates that there is a potential risk of severe liver damage for those taking the drug, arising after the 35-day observation period used in the study. Despite the awareness that chronic use of the product may adversely effect the liver, as referred to in the prescribing information, the specific observation that the compound may cause liver injury has not been previously made in relation to Exanta. This indicates, says the firm, that regular liver function monitoring, as was carried out during assessment of the drug, may not mitigate the risk.

While there is no evidence of liver damage with approved use of the product for up to 11 days, any unapproved use in excess of this treatment period is of concern. As a result, the firm says it has removed Exanta from sale, advised patients currently taking the treatment to consider changing to an alternative and will stop all development of the drug and cease the two ongoing clinical assessments with immediate effect.