The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration (FDA) is alerting healthcare providers of a change to the United States Pharmacopeia (USP) monograph for heparin, effective October 1, 2009. Manufacturers will not begin shipping heparin products manufactured and tested according to the new USP monograph until October 8th or later. This change—largely in response to the 2007-2008 heparin contamination problem—will include a new USP reference standard and test method that is used to determine the potency of the drug. The new test method, unlike the previous method, is able to detect impurities that may be present in heparin. The monograph change will also harmonize the USP unit dose with the WHO International Standard (IS) unit dose.
The manufacturing and testing requirements under the new monograph will lessen the potential for contamination of heparin and enhance the production of a high quality drug. However, harmonization of the standard will result in approximately a 10% reduction in the potency of the heparin marketed in the United States.
The change in heparin potency may have clinical significance in some situations, such as when heparin is administered as a bolus intravenous dose and an immediate anticoagulant effect is clinically important. In such situations healthcare providers should consider the change in potency of heparin when making decisions about what dose to administer. The change in heparin potency is expected to be less clinically significant when it is administered subcutaneously due to the low and highly variable bioavailability of heparin when administered by this route. Healthcare providers should also be aware of the decrease in heparin potency as they monitor the anticoagulant effect of the drug; more heparin may be required to achieve and maintain the desired level of anticoagulation in some patients.
For more information, please visit: Heparin
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