The Medical Letter on Drugs and Therapeutics
Correction: Natalizumab (Tysabri) for Crohn's Disease
Download PDF:   US English
Med Lett Drugs Ther. 2008 Jun 2;50(1287):44
 Select a term to see related articles  2008   adalimumab   Asacol   azathioprine   certolizumab   Cimzia   Cipro   Ciprofloxacin   correction   Crohn's disease   Flagyl   Humira   Imuran   infliximab   Issue 1285   Issue 1287   JC Virus   June 2   May 5   mercaptopurine   mesalamine   metronidazole   monoclonal antibody   natalizumab   Natalizumab (Tysabri) for Crohn's Disease   Page 34   Page 44   progressive multifocal leukoencephalopathy   Purinethol   Remicade   Steroids   TNF inhibitor   Tysabri   volume 50 

The May 5, 2008 article (Med Lett Drugs Ther 2008; 50:34) on the approval of natalizumab (Tysabri) for treatment of Crohn's disease in the "Adverse Effects" section on page 35 included the statement: "post-marketing hepatotoxicity, sometimes fatal or requiring liver transplantation, has occurred." Actually, no fatal hepatotoxicity or liver transplantation has been reported to date. The FDA warning about post-marketing hepatotoxicity with Tysabri that was the basis for our statement said: "The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to [emphasis added] death or the need for a liver transplant in some patients." Also, in the last sentence of the Conclusion, we should have said: "Because of the risk of serious hepatic toxicity and the rare but even more serious risk of developing progressive multifocal leukoencephalopathy, it should be used only in patients who have not responded to other drugs, including a TNF inhibitor." The italicized words should be substituted for "it is FDA-approved for use."

© The Medical Letter, Inc. All Rights Reserved.
The Medical Letter, Inc. does not warrant that all the material in this publication is accurate and complete in every respect. The Medical Letter, Inc. and its editors shall not be held responsible for any damage resulting from any error, inaccuracy, or omission.
This article has been freely provided.
arrow to previous article
arrow to next article