Health care professionals were notified by the U.S. Food and Drug Administration (FDA) as to changes in the manufacturing of heparin. A decrease in the potency of the drug is the expected result.
The United States Pharmacopeia (USP) has adopted new manufacturing controls over the anti-clotting drug. These new controls are expected to bring changes which include a modification of the reference standard for the drug’s unit dose. The changes are designed to increase the quality of the drug and protect against potential contamination.
The new controls take effect October 1, 2009. However, the FDA has requested that the new product not be shipped until October 8, or later.
According to John Jenkins, M.D. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, the delay will allow time for health care providers and facilities to learn about and make necessary adjustments to pharmacy procedures and dosing practices.
There are four companies in the United States that manufacture heparin. They include APP, Hospira, Baxter and B. Braun. These companies have been requested by the FDA to identify their new products. This request has been made to assist health care professionals and pharmacies with identifying the new product from the former one.
Part of these changes is a result of a 2007-2008 incident involving contaminated heparin manufactured in China. As a result, deaths were reported associated with the contaminated drug.