UPDATE: FDA Warns New Heparin Standards Will Cut Drug Potency
October 01 2009 - 3:54PM
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.
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.
The FDA said it's asked manufacturers identify their new
products with a label change to help pharmacies and health-care
professionals differentiate it from the former product. Both
current products and new products made under the revised standards
could co-exist for several months on hospital pharmacy shelves.
Jenkins explained that one of the manufacturers contacted the
agency about three weeks ago after it found the heparin it made
under the new USP standards was about 10% less potent than heparin
made under the old standards. The agency contacted the other
manufacturers who also found a similar change in potency.
The agency said APP Pharmaceuticalsis the largest heparin
manufacturer in the U.S. and sells the product in vials. Hospira
Inc. (HSP) markets heparin in intravenous bags, vials, and syringes
while Baxter and B. Braun market heparin in intravenous bags.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com