FDA Approves New Anti-Clotting Drug

The Food and Drug Administration (FDA) announced the approval of Arixtra (fondaparinux sodium) Injection for reducing the risk of blood clots after orthopedic surgery for hip fracture, hip replacement, and knee replacement. Arixtra is the first synthetic anticoagulant indicated for use in these types of surgeries.

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, such as when the clots break off and travel to the lungs. The drug works by inhibiting Factor Xa, a key component involved in blood clotting.

The major side effect of Arixtra is serious bleeding. Arixtra is not to be used in patients with severely impaired kidney function or in patients who weigh less than 110 pounds, because they may have an increased risk for serious bleeding. Elderly patients also may be more likely to experience serious bleeding complications.

In addition, the labeling for this product includes a black box warning that states Arixtra is not to be used when spinal anesthesia or spinal puncture is employed. There is a risk of developing a blood clot in the spine, which can result in long-term or permanent paralysis.