Heparin
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Heparin Information
Heparin is a naturally occurring anticoagulant produced by special cells within our biological makeup. It was first isolated and named in 1916 by a second year Johns Hopkins medical student. Its anticoagulant properties were recognized early, and by 1935 a chemically manufactured variant was developed that was safe for introduction into a human suspended in a salt solution.
Today, the drug is generally delivered intravenously in order to avoid clotting during surgery or further clotting if a patient is diagnosed with coronary blockage or pulmonary bleeding. It is also used extensively during kidney dialysis.
As with any drug, an overdose can be fatal. Adverse reactions to the medication can include severe hypotension, which is an extremely low heart rate. Nausea, vomiting and weakness have also been reported. Heparin has been in the news since the first of the year because of reports that contaminated batches of the drug have been in circulation.
In February Baxter International, the company that produces at least half the heparin used in the United States, recalled their heparin products due to potential contamination. Investigation has shown that Baxter’s heparin manufacturing source in China had been producing a contaminated product. Over eighty deaths have been attributed to contaminated heparin in the U.S. - in April the FDA announced that contaminated batches had also been found in ten other countries, with several deaths reported in Germany.
Also in April, a team of researchers at MIT laid out a complex formula by which contaminated heparin may have slipped through conventional screening processes. This created further concern in the medical products market. Heparin is also used to coat surgical products used in heart bypass procedures and other operations in order to avoid clotting. In April, the FDA recommended that medical devices coated with heparin be checked for contamination using newly developed testing methods.
On May 8th Medtronic Inc. recalled some of their medical devices because they may be coated with tainted heparin. The disposable medical devices, used during cardiac bypass surgery, are made with Medtronic’s Carmeda BioActive surface, which includes heparin. No injuries have been reported in relation to the Medtronic devices, but the recall underscores the enormous scope of the problems involving contaminated heparin.
Baxter has been faulted for its inspection of the Chinese facilities that produced their heparin. The Chinese have responded that Baxter’s oversight has been lax. Meanwhile, there has been speculation from many corners (including the FDA) that the contaminated heparin may have been the result of a deliberately altered manufacturing technique that supposedly was s substantial cost-cutting measure for the manufacturer.
Heparin In The News
Pig virus concern for Solvay enzyme -FDASource: Reuters (Recasts first paragraph, adds virus details, Creon revenues) By Susan Heavey WASHINGTON, Nov 28 (Reuters) - U.S. health regulators are concerned about the risk of patients contracting viruses ...
Cutting CostsSqueezed credit markets have reigned in spending at San Diego’s small and midsized biotech companies, many of which have less than a year’s worth of cash on hand to keep operations running.
Scientists Teach Enzyme To Make Synthetic Heparin In More VarietiesScientists at the University of North Carolina at Chapel Hill have learned to customize a key human enzyme responsible for producing heparin, opening the door to a more effective synthetic anticoagulant as well as treatments for other conditions. Jian Liu, Ph.D.
Baxter spent $720K lobbying government in 3QDrug and medical device maker Baxter International Inc. spent $720,000 lobbying on health care issues in the third quarter, according to a recent disclosure report.
Pig virus concern for Solvay enzyme -FDA(Recasts first paragraph, adds virus details, Creon revenues)
UNC scientists teach enzyme to make synthetic heparin in more varieties( University of North Carolina at Chapel Hill ) Scientists at the University of North Carolina at Chapel Hill have learned to customize a key human enzyme responsible for producing heparin, opening the door to a more effective synthetic anticoagulant as well as treatments for other conditions.
Scientists Teach Enzyme To Make Synthetic Heparin In More VarietiesScientists have learned to customize a key human enzyme responsible for producing heparin, opening the door to a more effective synthetic anticoagulant as well as treatments for other conditions.
Simple New Method Detects Contaminants In Life-saving DrugThe blood-thinning drug heparin is highly effective when used to prevent and treat blood clots in veins, arteries and lungs, but earlier this year its reputation as a lifesaver was sullied when contaminated heparin products caused serious allergic reactions that led to a large number of deaths.
UPDATE 2-Pig virus concern for Solvay enzyme -FDAWASHINGTON, Nov 28 (Reuters) - U.S. health regulators are concerned about the risk of patients contracting viruses from pig glands used to make Solvay Pharmaceuticals Inc's pancreatic enzyme product Creon, according to documents released on Friday.
(AFX UK Focus) 2008-11-28 17:37 UPDATE 2-Pig virus concern for Solvay enzyme -FDABy Susan Heavey
