The US Food and Drug Administration (FDA) has ruled to include stronger warnings for fungal infections caused by arthritis drugs.

The warnings apply to drugs like Amgen, Inc.’s Enbrel, Johnson & Johnson’s Remicade, Abbott Laboratories’ Humira, and UCB SA’s Cimza. The drugs Enbrel, Remicade, and Humira were among the top 25 selling drugs last year, with $13.5 billion in combined sales.

They are usually used to treat rheumatoid arthritis. According to the FDA, at least 241 patients have developed histoplasmosis—an infection caused by a fungus found in the Ohio and Mississippi river valleys. Twelve of the 45 reported deaths were caused by doctors who didn’t recognize the infection and delayed treatment for the infection; even more deaths have been reported from other fungal infections.

The FDA has forced companies to strengthen their existing cautions in the strictest form of caution: a black box in the drugs’ prescribing information. The drug manufacturers must also educate doctors about the risks and symptoms of fungal infections.

This entry was posted on Monday, September 8th, 2008 at 6:25 pm and is filed under Defective Drugs, Recall, Safety. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.