Enbrel drug gets black box infection-risk warning

Amgen Inc and Wyeth on Monday said their Enbrel arthritis drug will now carry a prominent black box warning on its package insert label in the United States, citing risks of tuberculosis and other infections, similar to warnings of rival treatments.

The same dangers have previously been printed in bold-face type in Enbrel’s package insert label. The new, and more-serious, black-box warning includes additional language regarding screening and monitoring patients for tuberculosis, the companies said in a release.

Enbrel, like Johnson & Johnson’s Remicade and Abbott Laboratories Inc’s Humira, works by blocking a naturally occurring protein called tumor necrosis factor that causes inflammation.

The widely used class of drugs, by taming the body’s immune system, can increase risk of infections.

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.