AstraZeneca withdraws blood clotting drug
The Anglo-Swedish drugs giant AstraZeneca said on Tuesday that it had decided to withdraw its Exanta treatment for blood clotting owing to concerns about the safety of the tablet drug.
The group took the decision after studies uncovered a risk of serious liver injury if the drug was used for more than 11 days - the limit for which AstraZeneca won marketing approval.
"While there is no evidence of a risk of liver injury with approved use up to 11 days, any unapproved use beyond 11 days is a concern," AstraZeneca said in a statement.
"Therefore, in the interests of patient safety, AstraZeneca is taking the precautionary measure of withdrawing Exanta.
"AstraZeneca has informed regulatory authorities of its decision to withdraw Exanta and is now communicating with all prescribers and healthcare professionals to advise them that no new patients should be started on Exanta."
Safety concerns have plagued the drug and hampered its progress since 2004.
The potential of liver damage prompted US regulators to decline marketing approval in late 2004. Exanta had been on sale in 12 countries, approved for a maximum 11-days use by patients who have undergone hip and knee replacement surgery.
The company estimates that about 400 people are currently being prescribed Exanta, which generated sales of 575,000 dollars (484,000 euros) last year.
"For patients currently taking Exanta, doctors should consider changing treatment to an alternative anti-coagulant," AstraZeneca said on Tuesday.
The price of share in AstraZeneca fell 0.95 percent to 2,597 pence in late afternoon London trade following the announcement of the withdrawal, while the capital's London FTSE 100 index of leading shares was 0.15 percent lower at 5,784.60 points.
AstraZeneca chief executive David Brennan said the company remained committed to the discovery and development of new medicines in the area of blood-clotting.
Brennan has replaced Tom McKillop, who stepped down as chief executive of AstraZeneca on January 1 following his resignation last July. Brennan had previously headed the group's US and Canadian operations.
AstraZeneca's key products include the stomach ulcer drug Nexium, the cholesterol buster Crestor and breast cancer treatment Arimidex.
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The group took the decision after studies uncovered a risk of serious liver injury if the drug was used for more than 11 days - the limit for which AstraZeneca won marketing approval.
"While there is no evidence of a risk of liver injury with approved use up to 11 days, any unapproved use beyond 11 days is a concern," AstraZeneca said in a statement.
"Therefore, in the interests of patient safety, AstraZeneca is taking the precautionary measure of withdrawing Exanta.
"AstraZeneca has informed regulatory authorities of its decision to withdraw Exanta and is now communicating with all prescribers and healthcare professionals to advise them that no new patients should be started on Exanta."
Safety concerns have plagued the drug and hampered its progress since 2004.
The potential of liver damage prompted US regulators to decline marketing approval in late 2004. Exanta had been on sale in 12 countries, approved for a maximum 11-days use by patients who have undergone hip and knee replacement surgery.
The company estimates that about 400 people are currently being prescribed Exanta, which generated sales of 575,000 dollars (484,000 euros) last year.
"For patients currently taking Exanta, doctors should consider changing treatment to an alternative anti-coagulant," AstraZeneca said on Tuesday.
The price of share in AstraZeneca fell 0.95 percent to 2,597 pence in late afternoon London trade following the announcement of the withdrawal, while the capital's London FTSE 100 index of leading shares was 0.15 percent lower at 5,784.60 points.
AstraZeneca chief executive David Brennan said the company remained committed to the discovery and development of new medicines in the area of blood-clotting.
Brennan has replaced Tom McKillop, who stepped down as chief executive of AstraZeneca on January 1 following his resignation last July. Brennan had previously headed the group's US and Canadian operations.
AstraZeneca's key products include the stomach ulcer drug Nexium, the cholesterol buster Crestor and breast cancer treatment Arimidex.
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