Heparin is a blood thinner and is often used for kidney dialysis patients as they spend hours connected to the blood purifying equipment. It prevents the blood from clotting as it moves slowly through the purifying process.
About a year ago, tainted Heparin was withdrawn from the market after the supplier, Baxter International Inc., and the U.S. Centers for Disease Control and Prevention (CDC) found that the Chinese manufacturing facilities had used over-sulfated chondroitin sulfate. There were hundreds of reports of serious allergic reactions and a number of deaths.
The CDC has done an intensive study of this contaminated Heparin and their report recently appeared in the New England Journal of Medicine. It confirms previously-published reports that this contaminated Heparin was indeed the cause of the reported adverse reactions.
The CDC Study
The CDC researchers obtained unopened vials of Heparin from 21 dialysis facilities which had reported allergic reactions and from 23 such facilities which had not. They found that most of the vials from facilities which reported allergic reactions were from Baxter. In contrast only about four percent of vials from the other facilities were from Baxter.
Looking at it all from the perspective of the total number of adverse reactions nationwide, they found that 98.5 of all reactions happened in dialysis facilities where the heparin tested positive for over-sulfated chondroitin sulfate. Special testing was done since the standard tests are unable to detect it.
Because standard tests cannot detect it, the FDA has mandated screening of all heparin products. Baxter has also pledged not to market any more heparin until it has devised a system of assuring its safety and quality.
Adverse Heparin reactions declined quickly after the first recall of tainted Heparin and ceased altogether after the second recall. This heparin episode would seem to be over, except that many people suffered severe side effects and some died. Please see our Prescription Drug Cases page for more information on this type of lawsuit.
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