|
FDA Alert: Enbrel (etanercept) Prescribing Information Revised To Include A Boxed Warning Regarding The Risk Of Infection, Including Tuberculosis
Summary
Amgen and Wyeth Pharmaceuticals informed healthcare professionals of revisions to prescribing information for Enbrel. The revisions include a BOXED WARNING about infections, including serious infections leading to hospitalization or death that have been observed in patients treated with Enbrel. Infections have included bacterial sepsis and tuberculosis.
The ADVERSE REACTIONS section of the label was updated to include information regarding global clinical studies and the rate of occurrence of tuberculosis in patients treated with Enbrel. Healthcare professionals should screen patients for latent tuberculosis infection before beginning Enbrel. Patients should be educated about the symptoms of infection and closely monitored for signs and symptoms of infection during and after treatment with the drug. Patients who develop an infection should be evaluated for appropriate antimicrobial treatment and, in patients who develop a serious infection, Enbrel should be discontinued.
Details
The ADVERSE REACTIONS: Infections section of the US PI has also been updated to include the following information: “In global clinical studies of 20,070 patients (28,308 patient-years of therapy), tuberculosis was observed in approximately 0.01% of patients. In 15,438 patients (23,524 patient-years of therapy) from clinical studies in the US and Canada, tuberculosis was observed in approximately 0.007% of patients. These studies include reports of pulmonary and extra-pulmonary tuberculosis (see WARNINGS).”
The ENBREL Patient Package Insert (PPI) is being converted to a Medication Guide. The Medication Guide is designed to provide important patient safety information and increase the awareness about the proper use of ENBREL. The Medication Guide will be distributed when a prescription for ENBREL is dispensed in the US.
Following approval by the FDA the Medication Guide will be available on Enbrel.com. We encourage you to review the full prescribing information.
To report adverse patient experiences or request further safety information on ENBREL, please contact Amgen’s Medical Information Connection™ at 1-800-77-AMGEN. Alternatively, adverse events may be reported to FDA’s MedWatch reporting system:
Phone (1-800-FDA-1088), by facsimile (1-800-FDA-0178)
Online (https://www.accessdata.fda.gov/scripts/medwatch/)
New Label
Source
May 1, 2008
|
