Drug Topics - January 28, 2008 - (Page 17) www.drugtopics.com JANUARY 28, 2008 DRUG TOPICS 17 FDA SAFETY PAGE Fatal medication errors with heparin he risk for fatal medication errors is highlighted as an important new warning within a revised product label for Heparin Sodium Injection (Baxter Healthcare Corp.) that was approved by the Food & Drug Administration on December 14, 2007. The new WARNINGS section states that fatal hemorrhages have occurred in pediatric patients following medication errors in which vials containing a highly concentrated heparin solution (10,000 units in 1 mL) were confused with 1-mL “catheter lock flush” (10 units in 1 mL) vials because of their visual similarity to one another (i.e., same size, shape, and similar color blue label). T cially when administering “catheter lock flush” solutions to pediatric patients and especially during the transition time from the older Heparin Sodium Injection vials to the newer vials. Significantly, these new vials will have a new NDC number. The new NDC numbers for products with the revised packaging and labeling are as follows: • Heparin Sodium Injection USP, 1000 units/mL (NDC 0642-0391-02) • Heparin Sodium Injection USP, 5000 units/mL (NDC 0641-0400-02) • Heparin Sodium Injection USP, 10,000 units/mL (NDC 0641-0410-02) Changes to the label Disseminate this information The new FDA-approved labeling also includes re- Please ensure this important safety information is disvised container labels for the highly concentrated seminated within your institution. We encourage organsolutions of Heparin Sodium Injection in 1-mL izations to make their staff aware of these product mixvials. Now, a tear-off laups and to take prebel extends above the cautions to avoid confumain label and must be Baxter Healthcare is currently sion of the 1-mL vials. removed in order to reConsider physically sepamove the flip-off cap. distributing Heparin Sodium rating the highly concenAdditionally, the 1-mL Injection 1-mL vials with the new trated heparin sodium 1vial labels are differentiatmL vials from the 1-mL ed by new colors (1,000 labels and other manufacturers “catheter lock flush” vials. units/mL are purple, of heparin are anticipated to make Full prescribing infor5,000 units/mL are ormation for Heparin Sodiange, and 10,000 the changes within the near future. um Injection, USP, inunits/mL are brown). cluding clinical trial These changes pertain only to these strengths of he- information, safety, dosing, drug-drug interactions, and parin contained within 1-mL vials. The labels for contraindications is available at: www.fda.gov/cder/ the 1-mL vials of heparin “catheter lock flush” have foi/lael/2007/017037s161lbl.pdf. not changed. Healthcare professionals should report all serious adNot all 1-mL vials of Heparin Sodium Injection verse events suspected to be associated with the use of contain the newly approved vial labels. Healthcare any medicine and device to FDA’s MedWatch Reporting facilities may have a considerable supply of 1-mL System by completing a form online at www.fda.gov/ vials with the older labels on inventory. Baxter medwatch/report.htm, by faxing to 800-FDA-0178, Healthcare is currently distributing Heparin Sodi- mailing the postage-paid address form provided online, um Injection 1-mL vials with the new labels and or by calling 800-FDA-1088. other manufacturers of heparin are anticipated to make the changes within the near future. This article was prepared by the Office of Oncology The highly concentrated solutions of Heparin Drug Products/Division of Medical Imaging and Hematology Products and Office of Surveillance and Sodium Injection within 1-mL vials contain potenEpidemiology/Division of Medication Errors and tially lethal heparin doses for some patients and vigTechnical Support, Food & Drug Administration. ilance is essential to avoid medication errors, espe- http://www.drugtopics.com http://www.fda.gov/cder/foi/lael/2007/017037s161lbl.pdf http://www.fda.gov/cder/foi/lael/2007/017037s161lbl.pdf http://www.fda.gov/medwatch/report.htm http://www.fda.gov/medwatch/report.htm
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