Amgen and Wyeth have updated the package insert for their tumor necrosis factor inhibitor Enbrel (etanercept) to include a "black box" warning on risk of infection, the firms announced March 17.

Labeling for the rheumatoid arthritis treatment already included a bolded warning on post-marketing reports of serious infections and sepsis, including death, as well as rare cases of tuberculosis associated with the drug.

The announcement does not come as a surprise, as Amgen had previously disclosed that FDA may require the language be shifted into a boxed warning, similar to that of other TNF inhibitors on the market, Johnson & Johnson's Remicade (infliximab) and Abbott's Humira (adalimumab) (¹ Also see "Enbrel “Black Box” Under Consideration By FDA, Amgen Execs Say" - Pink Sheet, 13 November, 2007.).

The companies said in a same-day news release they are informing physicians of the revised label via a "Dear Healthcare Professional" letter.

The new black box also contains language on screening and monitoring for TB, including patients who tested negative for latent infection, the firms noted. Tuberculosis may be due to reactivation of latent tuberculosis infection or new infections, the labeling states.

While TB risk has been observed following treatment with all anti-TNFs, the warning mentions 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."

Other PI updates include the addition of reported incidence of tuberculosis infection observed in clinical studies in the Adverse Reactions section. That section now includes information on the incidence of TB in clinical studies. In more than 20,000 patients in global clinical studies, TB was observed in approximately 0.01 percent of patients. In more than 15,000 patients from clinical studies in the U.S. and Canada, tuberculosis was observed in approximately 0.007 percent of patients, according to the label.

-Brooke McManus (b.mcmanus@elsevier.com)

Enbrel Label Gets “Black Box” On Tuberculosis Risk

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