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The Food and Drug Administration (FDA) announced this week safety labeling changes on the blood thinner heparin to include warnings of fatal medication errors that have resulted in heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia and thrombosis (HITT), in particular in neonates, or infants less than a year old.
A Food and Drug Administration (FDA) advisory panel voted last week to recommend agency approval of experimental blood thinner rivaroxaban, according to Forbes. The medication, made by Johnson & Johnson and Bayer Healthcare Pharmaceuticals, is designed to be used on a short-term basis to prevent pulmonary embolism and deep-vein thrombosis in patients having total knee or hip replacement surgery. Blood clots are common after such surgeries.
Just weeks after the FDA requested revised labeling for the low molecular weight heparin, Innohep, the FDA announced that its maker Celgene Corporation has issued a “Dear Healthcare Professional” letter describing a controlled clinical study that suggests an increased risk of death in elderly patients who received Innohep. Innohep contains tinzaparin sodium that is given to patients in conjunction with warfarin sodium intravenously to treat blood clots that have occurred deep in the veins of hospitalized patients who may or may not have also experienced the occurrence of blood clots in their lungs (pulmonary embolism).
New blood-thinning medicines are in the works and to offer doctors more options in treatment and prevention of blood clots, according to Bloomberg. Bloomberg reports that at least six companies are working on blood thinners to take advantage of a growing need. According to Datamonitor, a London-based research company, the anticoagulation drug market is expected to reach $20 million by 2012.
The FDA announced this week that it has received information about the Innohep in Renal Insufficiency Study (IRIS) that was stopped in February because of an interim finding of increased all-cause mortality in patients who received Innohep. Innohep contains tinzaparin sodium, a low molecular weight heparin that is given to patients in conjunction with warfarin sodium intravenously to treat blood clots that have occurred deep in the veins of hospitalized patients who may or may not have also experienced the occurrence of blood clots in their lungs (pulmonary embolism).
A drug development company, Glycotek, is establishing a laboratory at the Hershey Center for Applied Research (HCAR) in Hummelstown, Penn., to focus on a long sought after oral alternative to heparin to treat deep vein thrombosis and other thrombotic conditions, as well as cancer, according to Business Wire.
Five pharmaceutical companies are working on new medications to treat blood clots, also known as thrombosis, according to The Wall Street Journal. Thrombosis is a serious problem affecting nearly 900,000 Americans each year, and resulting in nearly 300,00 deaths annually. Currently, heparin and Vitamin K antagonists are the only two principal treatments for blood clots.
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