FDA Drug Safety Communication Update - April 6, 2010:
Studies to assess differences in heparin activity were performed in animals (in-vivo) and in human plasma (in-vitro). The results of the human plasma and animal studies were consistent in demonstrating an approximate 10% decrease in heparin activity of the "new" heparin products compared to "old" heparin products. The average activated partial thromboplastin time (aPTT) response to a dose of heparin changed in a dose-proportional manner.
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FDA Alert:
New USP Standards for Heparin Products Will Result in Decreased Potency
Adjustments may be needed to achieve desired anticoagulant effect in some patients
New Heparin to Ship Starting October 8
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Click here for an Example of Heparin Labels.
Click here for information about Heparin pre-filled flush syringes.
Click here for the Canadian Notice to Hospitals (English)
Click here for the Canadian Notice to Hospitals (French) |