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A top FDA official said more heparin may be needed for certain patients. John Jenkins, director of the FDA's Office Of New Drugs, said heparin is administered by health-care professionals and dosing is different for each patient.
The change, adopted by the United States Pharmacopeia, or USP, a nonprofit standards-setting organization, includes a revised reference standard for the drug's unit dose. The changes also require companies to test for a contaminant found in batches of Baxter International Inc.'s (BAX) heparin last year that was manufactured with tainted ingredients from China.
The change went into effect Thursday, but the FDA has asked four companies that market heparin in the U.S. to hold off shipping new heparin products until Oct. 8 to allow hospital pharmacies time to adjust dosing practices. Heparin is used in many surgery patients and patients undergoing kidney dialysis.
The FDA said the revised USP reference standard and unit definition for heparin is about 10% less potent than the former USP unit.
"Although the FDA-approved labeling for heparin has not changed, including the recommended doses, it is essential that health-care professionals be aware of the potential difference in potency between the old and new vials of heparin when administering the drug," Jenkins said.
Doug
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