News | December 10, 2012

FDA Changes Heparin Labeling to Increase Safety

Change to heparin container labels to clearly state the total drug strength

FDA Heparin Container Labels

December 10, 2012 — The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals, caregivers and patients about a change to the container and carton labels for heparin products.

The label change will require manufacturers of Heparin Lock Flush Solution, USP and Heparin Sodium Injection, USP to clearly state the strength of the entire container of the medication followed by how much of the medication is in 1 milliliter (mL). These modifications will eliminate the need for healthcare professionals to calculate the total amount of heparin medication in a product containing more than 1 mL, thereby reducing the risk of miscalculations that may result in medication errors.

Heparin is used to prevent blood clots from forming in people who have certain medical conditions or who are undergoing certain medical procedures that may increase the chance that clots will form, or to stop the growth of clots that have already formed in the blood vessels and to prevent blood clots from forming in catheters that are left in veins over a period of time.

Healthcare professionals, caregivers and patients should be aware that that there will be a transition period before and after the official implementation date on May 1, 2013, during which both the current heparin container labels and the revised heparin container labels will be available in the marketplace. To minimize the potential for medication errors, users should consider separating the supplies of “current” and “revised” labeled heparin, and use all of the supplies of the “current” heparin before using products with the “revised” container label.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online at www.fda.gov/MedWatch/report.htm; or
  • Download the form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.


For more information: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm331168.htm

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