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Laboratory studies performed at the request of the U.S. Food and Drug Administration (FDA) have shown that Heparin Sodium, USP (heparin) made under the new United States Pharmacopeia (USP) Monograph ("new heparin") has approximately 10% less blood-thinning (anticoagulant) activity compared to heparin prepared using the previous ("old") USP Monograph. The studies were performed in order to better understand the clinical impact of the change in potency for heparin.
The FDA first alerted the public to changes in the potency of heparin in a Public Health Alert in October 2009.
The results of these studies reinforce FDA's previous recommendation for healthcare professionals to exercise clinical judgment in determining the dose of heparin for a patient and consider the clinical circumstances where the potency decrease may require dosage adjustments and more frequent monitoring.
For more information please visit: Heparin
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