FDA orders tougher warnings on TNF drugs

Forty-five deaths have prompted the FDA to demand new warnings on TNF inhibitors. The agency received reports of 241 cases of the fungal infection histoplasmosis in patients taking the drugs, which are used to treat rheumatoid arthritis and other autoimmune disorders. Among them were 45 patients who died. In at least 21 cases, doctors didn't diagnose the problem and treatment was delayed; 12 of those cases were fatal.

The drugs--Remicade from Johnson & Johnson; Humira from Abbott Laboratories; Cimzia from UCB; and Enbrel, co-marketed by Amgen and Wyeth--already carry warnings of infection risk, including a specific warning about tuberculosis.

But the FDA wants specific language about histoplasmosis and other fungal infections, particularly because doctors appear to have overlooked them in those 21 patients. Twenty percent of the patients who developed the infections died, but more than half of those treated late didn't make it.

- check out Amgen and Wyeth's statement
- see the WSJ Health Blog post
- read the story in the New York Times

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