Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The blood thinner heparin will now include a new reference standard and test method that is used to determine the potency of the drug and detect impurities that may be present in it, according to a safety alert issued by the Food and Drug Administration (FDA). The change is effective as of October 1, 2009, and will harmonize the USP unit dose with the WHO International Standard unit does, which will result in an approximately 10 percent reduction in the potency of the heparin marketed in the United States.

The alert was issued to pharmacists, physicians, hospital risk managers and consumers, and advised those parties to be aware that the change may have clinical significance in some situations. Because of the decrease in potency, health care providers should monitor the anticoagulant effect of the drug in patients as more heparin may be needed to achieve and maintain the desired level of anticoagulation in some patients.

The FDA is working with the new manufacturers of heparin to ensure that an appropriate identifier is placed on heparin made under the new USP monograph. Most manufacturers will place an “N” next to the lot number. The agency also is working with heparin manufacturers to study the impact of this variation in potency, and will make the results of the study available soon.

Consumers should be aware that their doctor may prescribe a higher dose of heparin that normally received, or patients may receive more monitoring after receiving doses of heparin than previously.

The changes will start affecting the heparin used in the healthcare settings on or after October 8, 2009. Patients should contact their healthcare provider if they have any questions or concerns about their heparin treatment.

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