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FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency
Date:10/1/2009

Adjustments may be needed to achieve desired anticoagulant effect in some patients

New Heparin to Ship Starting October 8

SILVER SPRING, Md., Oct. 1 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common blood-clotting drug.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofit standards-setting organization, adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug's unit dose.

Manufacturers in the United States label the amount of heparin included in their products based on USP standards. The changes adopted by the USP for the heparin unit dose match the World Health Organization's International Standard (IS) unit dose definition that has been in use in Europe for many years. The revised USP reference standard and unit definition for heparin is about 10 percent less potent than the former USP unit.

A unit is the measure of a drug's activity in the body. For heparin, a unit dose is the measure of the drug's ability to block the blood's natural clotting ability (anticoagulation). Heparin's potency is determined by the dose of the drug required to produce a specific level of anticoagulation.

Manufacturers for the U.S. market have begun to make heparin using the new USP standard. While the USP manufacturing controls take effect Oct. 1 for production, the FDA has asked that they not ship this new product to customers until Oct. 8, 2009, or later. The delay will give health care providers and
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SOURCE U.S. Food and Drug Administration
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