新 聞 及 資 訊
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Change in heparin reference standard in United States Pharmacopeia (USP) monograph (English only) |
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Laboratory studies performed at the request of the US Food and Drug Administration have shown that Heparin Sodium, USP 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 results of these studies reinforce US Food and Drug Administration’s (FDA) 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm184687.htm
In Hong Kong, the above news has been reported once on 2.10.2009 in response to the FDA’s announcement. At that time, only Baxter Healthcare Ltd was using USP as reference for their heparin products, and the company had confirmed that their products were not marketed in HK. At present, all Baxter’s heparin products are not registered as the company has not renewed their registration in 2009.
Ends/Thursday, April 8, 2010
Issued at HKT 14:30
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