The FDA ordered that the class of drugs known as Tumor Necrosis Factor alpha blockers, which are also referred to as TNF blockers or anti-TNF, carry a warning on the packaging that their use carries the risk of developing a potentially deadly fungal disease called histoplasmosis. These drugs are marketed under the names CimziaHumira, and .
The packaging already is required to warn about fungal infections in general, but the new warnings will have to specifically call out histoplasmosis. This is a result of the FDA receiving reports of 240 patients who were taking TNF blockers that developed histoplasmosis. Of those 240, 45 patients died, including at least 12 who had not been immediately been diagnosed with histoplasmosis leading to a delay in treatment. The ages of these patients ranged from 8 to 86 years, however, none of the deaths involved children.
Histoplasmosis starts in the lungs and can spread to other organs in the body. If not treated in time, it can lead to death. In healthy people the body’s immune system is able to control the histoplasmosis infection. The risk is to people that have compromised immune systems, such as patients with AIDS or taking immune system suppressing drugs, such as alpha blockers.
The that causes histoplasmosis, histoplasma capsulatum, is found throughout the world. It grows in the ground and in material that is contaminated with bat or bird droppings. Concentrations can be especially high in bird roosts, caves where bats roost and poultry house litter. Histoplasmosis is also more common in the Mississippi and Ohio River Valleys.
Symptoms of histoplasmosis include shortness of breath, fatigue, cough and fever.
Anti-TNF drugs are used to treat rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, juvenile idiopathic arthritis, ankylosing spondylitis and Crohn’s disease.
The FDA published their directive on September 4th. You can read the actual release here