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AstraZeneca Withdraws Exanta from European Market Drug Failed to Gain FDA Approval in 2004

Feb 15, 2006 | Newsinferno News Staff

The Associated Press has reported that pharmaceutical giant, AstraZeneca PLC, has announced it is withdrawing its controversial blood-thinning drug Exanta from the market and ending its further development due to “links to liver injury.”

The drug is marketed only in Europe having been turned down for approval by the Food and Drug Administration in late 2004 due to concerns about its potentially serious adverse effects on the liver.

AstraZeneca admitted on Tuesday that its own recent trials had also revealed "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."

"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," AstraZeneca said in a statement.

According to the company, there was no evidence of a risk of liver injury with approved use of up to 11 days. Any unapproved use beyond 11 days, however, is a concern.

Some 400 patients are currently taking the blood thinning drug to prevent blood clots in hip- and knee-replacement surgery, AstraZeneca said. These patients will be switched to other treatments, while two continuing clinical trials of the drug will be abandoned.
In 2004, FDA reviewers said the company had failed to adequately address the risks of liver toxicity, heart attack, or drug-induced bleeding associated with Exanta.

Exanta was being sold in Germany, Portugal, Sweden, Finland, Norway, Iceland, Austria, Denmark, France, Switzerland, Argentina, and Brazil. AstraZeneca will withdraw all other regulatory applications in the U.S. and Europe.

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