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FDA approves synthetic blood thinner – Updates – Arixtra Injection

FDA approves synthetic blood thinner – Updates – Arixtra Injection – Brief Article

A new type of blood thinner that reduces the risk of blood clots following hip and knee surgeries has been approved by the FDA.

Arixtra Injection (fondaparinux sodium) is the first synthetic option available to people undergoing orthopedic surgery for hip fractures and hip and knee replacements. The formation of clots in the deep veins of the legs is common after these surgeries and can lead to serious and potentially fatal consequences, especially if the clots break off and travel to the lungs. Arixtra, which was approved in December 2001, works by inhibiting Factor Xa, a key component in causing blood clots.

All anti-clotting drugs, including Arixtra, can cause serious bleeding. Therefore, people with severely impaired kidney function or those who weigh less than 100 pounds should not use this drug. Elderly people also may be more likely to experience serious bleeding complications.

The FDA is requiring the makers of Arixtra–Sanofi-Synthelabo, Paris, and Organon, of West Orange, N.J.–to include a statement in the product’s labeling warning that the drug is not to be used when spinal anesthesia or spinal puncture is performed. There is a risk of blood clots forming in the spine, which can cause permanent paralysis.

COPYRIGHT 2002 U.S. Government Printing Office

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