The biologic, which is used to treat arthritis and psoriasis, which already included a warning over the risk of TB and other infections, but gets the more serious warning to suggest screening and monitoring patients for TB, including those who test negative for latent tuberculosis infection. The Black Box aslo notes that TB has been seen in patients receiving TNF-blocking agents, a group of meds that also includes Abbott’s Humira and Johnson & Johnson’s Remicade, which contain similar warnings.

In its statement, Amgen says TB may be due to reactivation of latent tuberculosis infection or to new infection. Moreover, the labeling notes TB has been seen in about 0.01 percent of patients who have taken Enbrel in clinical trials, although Amgen maintains data suggests the risk of reactivation of latent tuberculosis infection is lower with Enbrel than the other meds. Just the same, post-marketing cases of tuberculosis reactivation have been reported for all of the TNF blockers, including Enbrel.

Amgen, by the way, markets Enbrel in the US with Wyeth, which sells the med overseas.