Clinicians should be aware of new manufacturing controls that have decreased the potency of the anticlotting agent heparin by up to 10%, according to the US Food and Drug Administration (FDA).
The changes in manufacturing standards for heparin were developed by the US Pharmacopeia (USP), a nonprofit standards-setting organization, and are enforced by the FDA. While US manufacturers have labeled products that contain heparin based on USP standards, the recent changes modified the reference standard for the drug's unit dose to match the World Health Organization's International Standard unit dose that is used in Europe. The revision reduces the potency of heparin by about 10% when compared with the previous USP standard.
New controls as well as a new method to test heparin were needed to ensure that contaminated drug supplies could be identified more easily. In 2007 and 2008, heparin produced in China was intentionally tainted with oversulfated chondroitin sulfate, which mimics heparin's therapeutic action and lowers production costs. Contaminated drug supplies were linked with deaths and adverse events in US patients.
“The growth of economically motivated adulteration of medicines worldwide is a tragic byproduct of global supply chains,” said Roger Williams, MD, the USP's chief executive officer.
The FDA has cautioned that attention to the lower potency is most critical for patients who receive heparin in a bolus intravenous dose when an immediate anticoagulant effect is needed to treat or prevent life-threatening thromboses. The change in potency is not as clinically significant for patients who receive heparin subcutaneously because of lower or more variable bioavailability from this route of administration.
Lower potency also may require more frequent or more intensive monitoring of activated partial thromboplastin time or activated clotting time. The FDA has noted that no changes in approved labeling or recommended doses for heparin have been made. The agency has emphasized the importance of individualized heparin dosing to meet the specific needs of each patient.
The new manufacturing controls became effective on October 1, and shipments of the lower-potency drug were expected to begin on October 8. The FDA has asked manufacturers to label heparin products made according to the new standards with an “N” in the lot number or after the expiration date.
More information is available at http://www.usp.org/hottopics/heparin.html.
Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature
Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal
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