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FDA says heparin potency to be reduced
"To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia -- a non-profit standards-setting organization -- adopted new manufacturing controls for heparin," the FDA said in a statement. "These changes include a modification of the reference standard for the drug's unit dose."
In an alert issued to healthcare professionals Thursday, the FDA said: "The changes adopted by the USP for the heparin unit dose match the World Health Organization's International Standard 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," the FDA said.
Officials said for heparin, a unit dose is the measure of the drug's ability to block the blood's natural clotting ability. Heparin's potency is determined by the dose of the drug required to produce a specific level of anticoagulation.
While the USP manufacturing controls took effect Thursday, the FDA said it has asked manufacturers not ship the new product to customers until Oct. 8 or later so as to give healthcare providers time to learn about the changes and to make adjustments to their pharmacy procedures and dosing practices.
Copyright 2009 by United Press International
This news arrived on: 10/01/2009
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