Centocor strengthens Remicade warnings

Centocor, a subsidiary of Johnson & Johnson (JNJ), announced Wednesday that it is revising the label for Remicade infliximab anti-TNF antibody for rheumatoid arthritis (RA) to warn that its use may increase the risk of patients developing tuberculosis or other infectious diseases. The revised label includes a black box warning instructing that patients should be evaluated for latent tuberculosis with a skin test, and strengthens warnings about the risk of serious infections.

The announcement comes two days before FDA's Arthritis Drugs Advisory Committee is scheduled to discuss safety issues associated with two TNF antagonists for RA: Remicade and Enbrel etanercept from Immunex (IMNX). FDA will present an analysis indicating that in one post-approval study of 226 patients taking Remicade, 7.5% developed tuberculosis, while only 0.1% of patients who received Enbrel developed TB. ...