FDA: New USP Standards For Heparin Will Cut Potency
02 10월 2009 - 3:24AM
Dow Jones News
The U.S. Food and Drug Administration warned doctors about a
manufacturing change in heparin that's expected to decrease the
potency of the drug.
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 that was found in
batches of heparin last year that were manufactured with
ingredients from China, including heparin sold by Baxter
International Inc. (BAX).
The change went into effect Thursday, but the FDA has asked four
companies who 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.
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," the FDA said in a statement.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com