09/04/2008 - National Legal News

The Food and Drug Administration today ordered that stronger warnings be placed on four widely used immunosuppressive drugs used to treat rheumatoid arthritis and other serious illnesses due to elevated risks of fungal infections.

The four drugs affected by the order — Amgen Inc.’s Enbrel, Johnson & Johnson’s Remicade, Abbott Laboratories’ Humira, and UCB SA’s Cimzia — have been tied to over 240 cases of a fungal infection called histoplasmosis reported to the FDA. In the reported cases, nearly 20 percent of the infected patients died.

The four affected drugs are part of a class of medications known as tumor necrosis factor alpha blockers, which act to suppress the immune system and are used in the treatment of several conditions such as rheumatoid arthritis, juvenile idiopathic arthritis, Crohn’s disease, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

According to an FDA spokesman, the new warnings must be upgraded to highlight existing warnings of fungal infections and strongly warn doctors to take occurrence of histoplasmosis and other fungal infections into account when prescribing these medications. The drug manufacturers are required to submit labeling changes within 30 days.

Histoplasmosis is caused by the fungus Histoplasma capsulatum, which is endemic to the Ohio and Mississippi river valleys. The condition generally causes flu-like symptoms, but can spread beyond the respiratory system to cause potentially fatal problems in other organs of the body.