On September 4, 2008 the FDA "announced that the 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, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died."

In the press release that accompanied the announcement the FDA reported that based upon their review of material that they had available , 240 users of TNF-blockers were found to have contracted a fungal infection called histoplasmosis. Of the 240 cases identified, Remicade was thought to be responsible for 207 cases.

Histoplasmosis is a fungal infection that exhibits symptoms similar to the flu. It is most prevalent in states bordering the Ohio River valley and the lower Mississippi River. (Positive histoplasmin skin tests occur in as many as 80% of the people living in areas where H. capsulatum is common, such as the eastern and central United States.)

Unless an individual's immune system is suppressed the fungus remains asymptomatic. However, the immune systems of patients taking TNF inhibitors become suppressed as a result of therapy making them more likely to become symptomatic.

In patients who are immune suppressed, most have respiratory complaints like cough or shortness of breath. Others complain of unusual weight loss, fatigue and fevers. Their have also been reports of sores on the skin, bone sores, sores in the mouth or intestines and in some instances neurological complaints.

If untreated, these fungal infections can be fatal in as little as three weeks after symptoms are observed.

What is most shocking is that the Centocor and Johnson & Johnson the manufacturer and distributer of Remicade have consistently issued vague reports of the total number of histoplasmosis cases that they were aware of. For example, the label for Remicade only reports having information concernin two cases. Why did Johnson & Johnson and Centocor under report the risk? The FDA found 207 cases of histoplasmosis associated with Remicade, while Johnson & Johnson and Centocor reported only 2 cases. Why did they report only 1% of the total cases in their label?