Heparin Container Labeling Change
December 7, 2012
FDA issued a MedWatch on 12/06/12 alerting the public that labeling of heparin products will change to reduce the risk of calculation errors. The new labeling change will comply with United States Pharmacopeia (USP) standards for other injectable medications. The revised label will prominently display the total amount of heparin in the container, followed by the amount of heparin in 1 millimeter (mL). This will allow for simplified dose calculations of the total amount of heparin administered. See the Drug Safety Communication link below for examples of the revised heparin labeling.
The official implementation date is May 1, 2013. However, during the transition from the current labeling to the revised labeling there will be a period of time when both labeling formats will be in the marketplace. To reduce the risk of medication errors, users are advised to separate heparin products with the current labeling from product with the revised labeling, and to exhaust supplies of the current-labeled product before switching to the product with the revised labeling.
FDA is encouraging health care professionals who use heparin products to double check the label before preparing and administering heparin to ensure the correct dose. Patients are advised to contact their healthcare provider if they have further questions about heparin products. Adverse events from these products may be reported to FDA MedWatch program at www.fda.gov/medwatch/report.htm.
Additional Information is available at the following links:
- MedWatch Alert:
- Drug Safety Communication (includes examples of current and revised labeling):
December 7, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT