Enbrel Label Adds Black Box

Amgen and Wyeth have added a “black box” warning to the U.S. prescribing information (PI) of Enbrel. The warning relates to the risk of infections, including tuberculosis. The companies contend that this warning is similar to labeling for other medicines in the tumor necrosis factor (TNF) inhibitor class.

Previously, Enbrel’s label included a bolded warning regarding the risk of infections and tuberculosis. This information is now in a boxed warning and includes additional language regarding screening and monitoring patients for tuberculosis, including patients who tested negative for latent tuberculosis infection. In addition, the boxed warning states that tuberculosis has been observed in patients receiving TNF-blocking agents, including Enbrel, and that tuberculosis may be due to reactivation of latent tuberculosis infection or to new infection. The boxed warning notes that data from clinical trials and preclinical studies suggest that the risk of reactivation of latent tuberculosis infection is lower with ENBREL than with TNF-blocking monoclonal antibodies. The warning further notes that post-marketing cases of tuberculosis reactivation have been reported for TNF blockers, including Enbrel.

Also, one of Enbrel’s indications has been changed. The PI for juvenile idiopathic arthritis (JIA) — formerly called juvenile rheumatoid arthritis (JRA) — now has an updated JIA indication for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older.