September 5th, 2008

Four widely-used drugs to treat arthritis and Crohn’s disease have been ordered by the FDA to change their warning labels to alert patients to the risk of serious fungal infections.

The four drugs are: Remicade, Humira, Enbrel, and Cimzia.

Reports the Wall Street Journal:

“The FDA said it reviewed 240 reports of histoplasmosis, a particularly invasive respiratory disease with symptoms similar to the flu, in patients being treated with Enbrel, Humira, or Remicade. The FDA found one case of the disease in a patient taking Cimzia.

In 21 cases, health professionals didn’t recognize the disease, leading to delayed treatment, prolonged hospital stays and death in 12 of the patients involved.

Of the 240 cases, an additional 33 patients whose treatment wasn’t delayed also died.

…

The four drugs are part of a class of treatments known as TNF blockers. They target a compound known as tumor necrosis factor, which is overproduced in many patients with inflammatory diseases like arthritis and Crohn’s. TNF is potentially useful in destroying tumor cells, so blocking its activity in the body could raise one’s risk of cancer.”