Wednesday October 28, 2009
Reference Standard Change for Heparin

Source: www.fda.gov/Safety/medwatch

Effective October 1, 2009, there is a new reference standard and test method to determine the potency of heparin, as well as, impurities in heparin. This change will result in a 10% reduction in potency of heparin marketed in the United States.

Clinicians should take caution with monitoring and dosing, as more heparin may be needed to achieve and maintain desired level of anticoagulation in patients.

Product with the new “USP unit” potency definition will be available on or after October 8, 2009. Most manufacturers will place an “N” next to the lot number to indicate that the vial is of the new potency.