To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Enbrel Label Updated To Include Infection, Sepsis Warning URL: http://www.pslgroup.com/dg/FCD26.htm Doctor's Guide May 11, 1999
SEATTLE, WA -- May 11, 1999 -- Immunex Corp. and Wyeth Ayerst are updating the prescribing information for Enbrel(R) (etanercept), a drug indicated to treat moderately- to severely-active rheumatoid arthritis for patients who have failed one or more disease-modifying anti-rheumatic medicines. Enbrel was approved by the United States Food and Drug Administration on Nov. 2, 1998. The current label for Enbrel states that the drug should not be used with patients who develop a serious infection or who have sepsis. Immunex and Wyeth Ayerst are updating this label, advising doctors not to start the drug in patients who have an active infection. Additionally, physicians should exercise caution when considering the use of Enbrel in patients with a history of recurring infections or with underlying conditions that may predispose patients to infections, such as advanced or poorly controlled diabetes. Patients who develop a new infection while on Enbrel should be monitored closely. Since Enbrel was approved, the drug has been prescribed to more than 25,000 patients and more than 1,500 clinical trial participants are being monitored for long-term efficacy and safety. Adverse events reported to the companies are similar to those monitored in the long-term clinical trials and to those addressed in the FDA approved package insert for Enbrel. At this point, there has been no apparent increased rate of reported events with increased and longer-term use of Enbrel. In post-marketing surveillance of more than 25,000 patients on Enbrel over the first five months since launch, 30 patients treated with Enbrel are reported to have developed serious infections including several reports of sepsis. Six of the patients with infections died, a number of whom had a history of chronic or recurrent infections, pre-existing infections, diabetes mellitus or other conditions that predisposed to infections, in addition to their severe rheumatoid arthritis. "The patients I and other rheumatologists treat with Enbrel often have long-standing, severely-active disease," said Dr. Arthur Weaver, M.D., M.S., F.A.C.P., F.A.C.R., director, clinical research, Arthritis Center of Nebraska, clinical professor of medicine, University of Nebraska Medical Center, who has been an investigator in the clinical trials of Enbrel for three years. "It is not uncommon for these patients to have complex medical histories including underlying risk factors that could lead to infection. It is not surprising or unexpected that patients of this nature may develop infections. I'm aware of the Enbrel post-marketing data and remain comfortable prescribing Enbrel for appropriate patients under appropriate circumstances." The mortality rate due to infection reported during the first five months of post-marketing experience is consistent with the rate observed with Enbrel in clinical studies and also in a rheumatoid arthritis patient population not taking Enbrel. There has been no evidence of increased risk for opportunistic infection associated with Enbrel. The most frequently reported adverse events in studies with Enbrel were mild to moderate injection site reactions. The long-term effects of Enbrel treatment, on the development or course of active and/or chronic infection, malignancy and autoimmune disease are unknown. Patients with a serious infection, including sepsis, or who are allergic to Enbrel or any of its components should not take the drug. If patients develop an infection while on Enbrel, they should talk with their doctor and be monitored closely. Enbrel should not be initiated in patients with active infections, including chronic or localised infections. Physicians should exercise caution in patients with a history of recurring infections or with underlying conditions, which may predispose them to infections, such as advanced or poorly controlled diabetes. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.