Published at www.nejm.org December 3, 2008 (10.1056/NEJMoa0806450) |
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Published at www.nejm.org December 3, 2008 (10.1056/NEJMoa0806450) |
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Background In January 2008, the Centers for Disease Control and Prevention began a nationwide investigation of severe adverse reactions that were first detected in a single hemodialysis facility. Preliminary findings suggested that heparin was a possible cause of the reactions.
Methods Information on clinical manifestations and on exposure was collected for patients who had signs and symptoms that were consistent with an allergic-type reaction after November 1, 2007. Twenty-one dialysis facilities that reported reactions and 23 facilities that reported no reactions were included in a case–control study to identify facility-level risk factors. Unopened heparin vials from facilities that reported reactions were tested for contaminants.
Results A total of 152 adverse reactions associated with heparin were identified in 113 patients from 13 states from November 19, 2007, through January 31, 2008. The use of heparin manufactured by Baxter Healthcare was the factor most strongly associated with reactions (present in 100.0% of case facilities vs. 4.3% of control facilities, P<0.001). Vials of heparin manufactured by Baxter from facilities that reported reactions contained a contaminant identified as oversulfated chondroitin sulfate (OSCS). Adverse reactions to the OSCS-contaminated heparin were often characterized by hypotension, nausea, and shortness of breath occurring within 30 minutes after administration. Of 130 reactions for which information on the heparin lot was available, 128 (98.5%) occurred in a facility that had OSCS-contaminated heparin on the premises. Of 54 reactions for which the lot number of administered heparin was known, 52 (96.3%) occurred after the administration of OSCS-contaminated heparin.
Conclusions Heparin contaminated with OSCS was epidemiologically linked to adverse reactions in this nationwide outbreak. The reported clinical features of many of the cases further support the conclusion that contamination of heparin with OSCS was the cause of the outbreak.
Source Information
From the Epidemic Intelligence Service Program (D.B.B., A.J.K., J.L.J., K.M.K., S.F.S.), the Office of Workforce and Career Development (D.B.B., A.J.K., K.M.P., J.L.J., K.M.K., S.F.S., D.K.), and the Division of Healthcare Quality Promotion (D.B.B., A.J.K., P.R.P., S.F.S., N.S., A.S., C.V.G., M.J.A.), Centers for Disease Control and Prevention, Atlanta; St. Louis Children's Hospital (A.E.), BJC Healthcare (M.J.), and the Missouri Department of Health and Senior Services (G.T.) — all in St. Louis; the Departments of Biological Engineering (L.R., G.G., R.L., R.S.) and Chemical Engineering (R.L.), the Harvard–MIT Division of Health Sciences and Technology (R.L., R.S.), and the Koch Institute for Integrative Cancer Research (L.R., G.G., R.L., R.S.), Massachusetts Institute of Technology; and Momenta Pharmaceuticals (G.V., T.K.K., Z.S.) — both in Cambridge, MA; the Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (A.W.M., S.K.); and Brigham and Women's Hospital and Harvard Medical School, Boston (K.F.A.).
This article (10.1056/NEJMoa0806450) was published at www.nejm.org on December 3, 2008. It will appear in the December 18 issue of the Journal.
Address reprint requests to Dr. Patel at the Centers for Disease Control and Prevention, 1600 Clifton Rd., MS-A31, Atlanta, GA 30333, or at ppatel{at}cdc.gov.
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