July 3, 2000 - The FDA has approved a new blood thinner to prevent and treat abnormal blood clotting related to heparin use. The drug is argatroban (Novastan), developed by Texas Biotech. It blocks thrombin, a key factor in blood clotting.
Heparin is given to more than 12 million people a year to prevent blood clots. As many as 360,000 of these patients develop abnormal blood clotting, known as HIT (heparin-induced thrombocytopenia). About 120,000 of these patients develop a serious complication from HIT, such as stroke or limb amputation. Up to 36,000 patients a year die from complications.
HIT usually happens 5 to 10 days after heparin treatment. Diagnosis can be difficult and is made tougher because doctors expect bleeding - not clotting - with this kind of condition. So doctors sometimes worsen the condition by continuing blood thinner therapy. Argatroban is the first direct thrombin inhibitor approved to prevent and treat abnormal clotting in HIT patients.
Argatroban's safety and effectiveness were shown in 2 clinical trials of 568 patients getting the drug versus 193 untreated "controls." All were diagnosed with HIT. Argatroban improved outcomes for the HIT patients. In trials with patients monitored for over a month, 34% of argatroban patients suffered death, amputation or new clot compared to 43% of controls.
Source: Reuters Health
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