› $4.85 Billion settlement in drug case
Cancer Consultants, an oncology resource center, is reporting that prophylactic use of nadroparin, a low-molecular-weight heparin, significantly reduces the incidence of thromboembolic events in patients who have cancer and are undergoing chemotherapy. This finding was presented this week by Italian researchers with the PROTECHT Study, at the annual meeting of the American Society of Hemotology.
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).
Drug maker Baxter International Inc., shelled out more than $720,000 in the third quarter of the year lobbying on health care issues including government reimbursement for kidney dialysis treatment and increased funding for kidney disease education, according to Forbes/Associated Press.
Scientists at University of North Carolina at Chapel Hill have learned to modify the human enzyme that produces heparin, which may lead to a more effective synthetic version of the blood thinner, according to Newswise Medical News.
Heparin may serve as a very inexpensive and effective new treatment for septic shock, according to Canada.com.
Septic shock is a serious condition that can cause multiple organ failure and death. It is the main cause of mortality in intensive care units (ICU), with a mortality rate of up to 40 percent.
Heparin remains in high demand in the United States, with more than 300,000 doses used daily. The blood thinner, which has been widely used since the 1930s, saves lives by preventing potentially fatal blood clots and reducing the amount of time patients with kidney failure stay on dialysis machines. However, controversy surrounds the medication and companies are quickly working on alternatives.
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.
FDA advises health care practitioners to switch suppliers and limit use of drug until problem identified
The U.S. Food and Drug Administration announced today that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive high “bolus” doses of the drug.
