FDA Issues Warning On Arthritis Drugs Over Deaths

By Alice Turner
September 7th 2008
eFlux Media

The U.S. Food and Drug Administration issued a statement which highlights that manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs’ prescribing information and Medication Guides, to better highlight the risk of developing fungal infections. The FDA found that several patients with invasive fungal infections have died.

Humira, Cimzia, Enbrel, and Remicade are tumor necrosis factor alpha blockers (TNF-alpha blockers) which are immunosuppressors, reducing the activity of a person’s immune system, thus possibly exposing them to a higher risk of various diseases. They are used to treat diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn’s disease. More…