In February 2008, reports of hundreds of adverse reactions and nearly 150 deaths were reported among patients give heparin, a commonly used blood-thinner. In response, Baxter Pharmaceuticals recalled nine lots of its heparin products, primarily, multi-dose vials, and FDA issued a Public Health Advisory. The cause was soon identified: the heparin had been contaminated with an "over-sulfated" derivative of chondroitin sulfate-evidently yet another example of economic adulteration. FDA contacted USP to validate and optimize two methods and update the monograph and Reference Standards for heparin. Stages 1 and 2 were completed by updating the heparin monograph through constructive and successful collaboration. Stage 3 revisions are currently under way.
Published Oct 7, 2010
