October 1, 2009 — Thanks to the contamination of heparin in China during a manufacturing step, changes in the drug are taking place that will affect you if you receive heparin as part of any treatment such as kidney dialysis or to prevent blood clots.

The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common anti-clotting drug by about 10% per USP unit. The FDA thinks it is essential that health care professionals be aware of this change.

GrassRootsAnnie.com believes it is also essential for patients to be advised of this significant difference. Although changes in production of the drug take place today, the FDA has asked that the new product does not ship to customers until Oct. 8, 2009, or later. The delay will give health care providers and facilities time to learn about the changes and to make adjustments to their pharmacy procedures and dosing practices,

The monograph for heparin was revised, in part, in response to a 2007- 2008 incident of heparin contamination involving a manufacturing step in China. The contaminated heparin was associated with deaths and other adverse events in the United States. The monograph was changed to include a test for the contaminant.

The changes adopted by the USP (United States Pharmacopeia, a nonprofit standards-setting organization,) for the heparin unit dose now match the World Health Organization’s International Standard (IS) unit dose definition that has been in use in Europe for many years. The FDA has posted a page on its web site for consumers. If you have additional questions, consult your physician.

 A unit is the measure of a drug’s activity in the body. For heparin, a unit dose is the measure of the drug’s ability to block the blood’s natural clotting ability (anticoagulation). Heparin’s potency is determined by the dose of the drug required to produce a specific level of anticoagulation.

Four companies market heparin in the United States. APP, the largest manufacturer, markets heparin in vials; Hospira markets heparin in intravenous bags, vials, and syringes; Baxter markets heparin in intravenous bags, and B. Braun markets heparin in intravenous bags. The FDA has asked that all manufacturers identify their new products to help pharmacies and health care professionals differentiate it from the former product.

Prescription and over–the–counter medicines available in the United States must generally meet USP's public standards, when such standards exist. The revised standards for heparin are contained in a new USP monograph.