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Medical Areas: Hematology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Organon, Sanofi-Synthelabo
Approval Status: Approved December 2001
Treatment Area: Deep vein thrombosis prophylaxis
Arixtra, an injectable solution for subcutaneous use, has been
approved as a preventative treatment for deep vein thrombosis (DVT)
in adults undergoing hip fracture, hip replacement, or knee
replacement surgery. It is adminstered through a single dose,
prefilled syringe, affixed with an automatic needle protection
system. Arixtra is the only antithrombotic agent approved in the
United States for hip fracture surgery.
DVT is caused by a blood clot forming in a deep vein in the leg.
It may cause pain and swelling, and enlargement and discoloration
of the veins. The clot can grow in size and block other veins. Most
seriously, portions of the clot may break away and travel through
the veins to the lungs, leading to a life threatening pulmonary
International randomized, double-blind phase III trials
evaluated the use of Arixtra in more than 7,000 subjects undergoing
hip fracture, hip replacement or knee replacement surgeries.
Results demonstrated Arixtra to provide a superior benefit in
comparison to the reference treatment.
Adverse events associated with the use of Arixtra may include
(but are not limited to) the following:
- Bleeding complications
- Mild irritation at injection site
Mechanism of Action
Arixtra (fondaparinux sodium) exhibits antithrombotic activity,
which is the result of antithrombin III (ATIII)-mediated selective
inhibition of Factor Xa. By selectively binding to ATIII,
fondaparinux sodium activates the innate neutralization of Factor
Xa by ATIII. This neutralization interupts the blood coagulation
cascade and thus inhibits thrombin formation and thrombus