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New USP Standard for Heparin Decreases Unit Dose Potency, Dictates Careful Monitoring
American Family Physician, 10/09/09

The FDA is alerting physicians about a change in heparin manufacturing that likely will decrease the potency of the widely used anticoagulant by 10 percent. FDA officials said the U.S. Pharmacopeia, or USP, monograph for heparin has been revised, in part, because of product contamination in 2007 and 2008 that was associated with adverse events, including deaths. The primary changes to the monograph include the implementation of a new USP reference standard and test method that is used to determine the potency of the drug. Heparin products that use the new USP unit are expected to be available on or after Oct. 8, but older versions of the drug likely will still be in circulation. Accordingly, the FDA said it has asked manufacturers to label new heparin products in a manner that will help differentiate them from the old products.

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