ROCKVILLE, Md -- October 1, 2009 -- The US Food and Drug Administration (FDA) is alerting healthcare professionals to a change in heparin manufacturing that is expected to decrease the potency of the common blood-clotting drug.
To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofit standards-setting organisation, adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug's unit dose.
Manufacturers in the United States label the amount of heparin included in their products based on USP standards. The changes adopted by the USP for the heparin unit dose match the World Health Organization's International Standard (IS) unit dose definition that has been in use in Europe for many years. The revised USP reference standard and unit definition for heparin is about 10% less potent than the former USP unit.
Manufacturers for the US market have begun to make heparin using the new USP standard. While the USP manufacturing controls take effect October 1 for production, the FDA has asked that they not ship this new product to customers until October 8, 2009, or later. The delay will give healthcare providers and facilities time to learn about the changes and to make adjustments to their pharmacy procedures and dosing practices, according to John Jenkins, MD, Office of New Drugs in the FDA's Center for Drug Evaluation and Research, Rockville, Maryland.
"Although the FDA-approved labelling for heparin has not changed, including the recommended doses, it is essential that healthcare professionals be aware of the potential difference in potency between the old and new vials of heparin when administering the drug," said Dr. Jenkins.
The FDA has asked that all manufacturers identify their new products to help pharmacies and healthcare professionals differentiate it from the former product.
SOURCE: US Food and Drug Administration
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