Enbrel to carry black box warning

MADISON, N.J. & THOUSAND OAKS, Calif. Amgen and Wyeth have announced that their arthritis drug Enbrel (etanercept) will now carry a black box warning on its package label in the U.S., citing risks of tuberculosis and other infections, according to published reports.

The same dangers had been previously printed in boldface type in Enbrel’s label. The new warning includes language regarding screening and monitoring patients for tuberculosis, the companies said. Tuberculosis has been seen in about 0.01 percent of patients who have taken Enbrel in clinical trials, the companies said.

The U.S. drugmakers jointly sell Enbrel in the United States. Wyeth markets the injectable medicine in overseas markets.

According to Amgen, Enbrel had sales of $3.23 billion in 2007.