Associated Press
February 14, 2006 10:41 a.m.
LONDON -- Pharmaceutical maker AstraZeneca PLC said Tuesday that it has decided to withdraw its controversial anticoagulant Exanta from the market and terminate its development because of links to liver injury.
The drug is dispensed only in Europe. It failed to receive approval from the U.S. Food and Drug Administration in late 2004 because of concerns about its effect on the liver.
The Anglo-Swedish company said Tuesday that its own trials had recently indicated "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.
The company said that while there was no evidence of a risk of liver injury with approved use of up to 11 days, any unapproved use beyond 11 days is a concern.
AstraZeneca said that about 400 patients are currently being prescribed the blood thinning drug for the prevention of blood clots in hip- and knee-replacement surgery. They will be switched to other treatments and two continuing clinical trials will be abandoned.
FDA reviewers said in 2004 that the company hadn't adequately addressed the risks of liver toxicity, heart attack, or drug-induced bleeding associated with Exanta.
AstraZeneca sold Exanta in Germany, Portugal, Sweden, Finland, Norway, Iceland, Austria, Denmark, France, Switzerland, Argentina and Brazil. The company will withdraw all other regulatory applications in the U.S. and Europe.
Copyright © 2006 Associated Press
February 14, 2006 10:41 a.m.
LONDON -- Pharmaceutical maker AstraZeneca PLC said Tuesday that it has decided to withdraw its controversial anticoagulant Exanta from the market and terminate its development because of links to liver injury.
The drug is dispensed only in Europe. It failed to receive approval from the U.S. Food and Drug Administration in late 2004 because of concerns about its effect on the liver.
The Anglo-Swedish company said Tuesday that its own trials had recently indicated "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.
The company said that while there was no evidence of a risk of liver injury with approved use of up to 11 days, any unapproved use beyond 11 days is a concern.
AstraZeneca said that about 400 patients are currently being prescribed the blood thinning drug for the prevention of blood clots in hip- and knee-replacement surgery. They will be switched to other treatments and two continuing clinical trials will be abandoned.
FDA reviewers said in 2004 that the company hadn't adequately addressed the risks of liver toxicity, heart attack, or drug-induced bleeding associated with Exanta.
AstraZeneca sold Exanta in Germany, Portugal, Sweden, Finland, Norway, Iceland, Austria, Denmark, France, Switzerland, Argentina and Brazil. The company will withdraw all other regulatory applications in the U.S. and Europe.
Copyright © 2006 Associated Press
