Health Alert: New Heparin Less Potent
October 5th, 2009
The Food and Drug Administration (FDA) advised health care professionals Oct. 1 that a new version of heparin due to start shipping Oct. 8 is 10 percent less potent, and that this reduced potency could weaken its ability to prevent blood clots.
As a result of this reduced potency, physicians may need to prescribe more of the blood-thinning drug and order more tests to monitor its affect on their patients.
“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 in an Oct. 1 telephone press briefing.
According to an FDA Public Health Alert, three of the four heparin suppliers are using the letter “N” on the product to alert health care providers that the product is the new version. The fourth manufacturer, Hospira, is using a numeric code to designate the new version.
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