Herbal Spotlight
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 heparin |
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Pharmaceutical
company:
Various heparin manufacturers
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NEW WARNING
The Food and Drug Administration (FDA) is alerting health care providers of a change to the heparin monograph. Beginning October 8, 2009, manufacturers will start shipping heparin following the new monograph, which was instituted in response to contamination problems occurring in 2007-2008. A new USP reference standard and test method will be used to determine heparin's potency and detect any impurities in the drug.
The new standard will result in a 10% reduction in heparin potency, which may have clinical significance when the drug is administered as an I.V. bolus dose and an immediate anticoagulant effect is desired. This change in potency is expected to have less of an effect when heparin is administered subcutaneously.
To help differentiate the new potency heparin from the old products, manufacturers such as Baxter Healthcare will identify the new products by inserting an "N" in the lot number or after the expiration date. Products manufactured by Hospira will have the number "82" or higher at the beginning of the lot number. Old and new products will be available at the same time with potency differences; therefore health care providers should consider variations in potency when prescribing the patient's dose. The potency change may require more frequent PTT or activated clotting time monitoring to help achieve the desired dose.
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