Drug Criteria & Outcomes: New FDA Approvals
February 1, 2002 less than 1 minute read
Drug Criteria & Outcomes: New FDA Approvals
These drugs recently received final approval from the Food and Drug Administration (FDA):
• Fondaparinux sodium (Arixtra) by Sanofi-Synthelabo and Organon. The FDA has approved fondaparinux sodium (Arixtra) injection for reducing the risk of blood clots after orthopedic surgery for hip fracture, hip replacement, and knee replacement. Fondaparinux sodium is the first synthetic anticoagulant indicated for use in these types of surgeries.
The major side effect of fondaparinux sodium is serious bleeding. Fondaparinux sodium is not to be used in patients with severely impaired kidney function or in patients who weigh less than 110 pounds. 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 fondaparinux sodium 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.
• Trimethobenzamide hydrochloride (Tigan ) by King Pharmaceuticals. The FDA has approved the new drug application (NDA) for Trimethobenz-amide hydrochloride (Tigan) 300 mg capsules. Trimetho-benzamide hydrochloride is indicated for the treatment of post-operative nausea and vomiting and for nausea associated with gastroenteritis.
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