FDA Wants New Arthritis Drug Warnings

Arthritis drugs can help to relieve pain, but they also suppress the immune system, which can cause patients to be more susceptible to infection. There are currently four approved TNF (tumor necrosis factor) alpha blockers that are approved to treat conditions including rheumatoid arthritis. Even though all four of the drugs already carry the FDA's strongest labeling warning, known as the black box warning, the FDA is asking this warning be consistent across all four drugs and the language be updated. To draw the attention of doctors to the possibilities that the drugs can lead to histoplasmosis or fungal infections which can be deadly if not recognized early and treated.

The FDA's decision to require better directed warnings resulted from an investigation after several deaths of patients taking one of the four arthritis drugs resulted from fungal infections. Though the black box warning already stated that the drugs could cause fungal infections, it seems many doctors were not stressing these warnings nor recognizing some of the signs associated with fungal infection in patients being treated with TNF drugs. The four drugs currently on the market that treat arthritis and work by suppressing the immune system are Enbrel, Remicade, Humira, and Cimzia.

The FDA evaluated 240 patients, ranging from age 8 to 86, taking Enbrel, Humira, or Remicade who suffered from histoplasmosis and one case of a patient who was taking Cimzia. 45 patients died as a result of the infections, none were children. There were 21 patients who were diagnosed late resulting in later treatment which resulted in 12 deaths. Patients need to know the symptoms of histoplasmosis as well as doctors. The infection could be mistaken for the flu with its symptoms, such as a never ending fever, cough, shortness of breath, and fatigue. If you experience these symptoms seek medical attention and make sure to tell the health care professional all drugs you are currently taking, along with the area where you live and anywhere you have visited recently. Fungus is most commonly found in the areas of the Mississippi River Valley and the Ohio River.

The FDA would like for doctors and patients to realize the risks involved with taking these drugs, used to treat several conditions including rheumatoid arthritis, Crohn's disease, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, and ankylosing spondylitis.

Dr. Jeffery Siegel, clinical team leader for the FDA's Center for Drug Evaluation and Research, points out that the FDA has known the possibilities of serious infections since the drugs were approved and warnings of infections, including fungal infections, are already on the labels. However, they now realize that some doctors may not be recognizing the symptoms of the fungal infections quick enough and awareness of the symptoms needs to be elevated. Through better warnings, to both health care professionals and patients, the FDA hopes to raise awareness of possible side effects of the TNF drugs.