FDA Announces Changes to Potency of Blood Thinner Heparin

The Food and Drug Administration today is alerting physicians and other health care professionals about changes to the popular blood thinner heparin which are designed to make it easier to detect contamination of the drug but will result in decreased potency.

In 2007 and 2008, an outbreak of contaminated heparin made by Baxter Pharmaceuticals resulted in 200 deaths and hundreds of serious injuries to patients. It was later determined that the Chinese manufacturer of the drug had substituted a counterfeit active ingredient in the drug, causing some users to suffer severe allergic reactions and other medical complications.

Baxter-brand heparin was recalled in 2008 after the reports of deaths and injuries in patients given the drug.

Changes in Potency of Heparin

Changes made by the United States Pharmacopeia (USP), which sets manufacturing controls and other standards for drugs, will result in heparin that is administered using the former potency definition being about 10 percent less potent, the FDA said.

Manufacturers of heparin products in the United States have already started making the drug using the new USP standards, but those doses are not being circulated until Oct. 8 or later to give health care professionals time to learn about the dosing changes and make necessary adjustments, the FDA said.

“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,” said John Jenkins, M.D. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.

New Test to Detect Contamination

As part of the new USP standards for heparin, a new test method will be included that, unlike the previous testing method, can detect impurities that may be present in heparin, the FDA said.

Heparin that is sold in the U.S. is made by one of four manufacturers, including APP, Hospira, B. Braun, and Baxter, according to the FDA.

The change in heparin potency may be important in certain medical situations, such as when heparin is administered as a bolus intravenous dose and an immediate anticoagulant effect is clinically important, the FDA said.

Therefore, healthcare providers in those situations should be sure to consider the change in potency of heparin when making decisions about what dose to administer the heparin.

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