Humira, the TNF (tumor necrosis factor) alpha blocker drug used to suppress the immune system for patients with rheumatoid arthritis, juvenile idiopathis arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis and Crohn's disease, has been linked to fungal infections that may have caused several deaths according to the U.S. Food & Drug Administration (FDA) which is requiring manufacturers to alert patients and prescribers of the risks.

What is Humira?

Humira (alalimumab), manufactured by Abbott Laboratories and approved by the FDA in 2002, is prescribed for patients with rheumatoid arthritis, juvenile idiopathis arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis and Crohn's disease.

Why could it be dangerous?

Abbott provides the following warning:

Serious infections have happened in patients taking HUMIRA. These infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some of these serious infections have been fatal. Patients treated with HUMIRA also may be at risk for other serious side effects including certain types of cancers, allergic reactions, hepatitis B virus reactivation, nervous system problems, blood problems, heart failure, and certain immune reactions, including a lupus-like syndrome. (Source: www.humira.com)

However, the FDA has indicated that the warning is not strong enough as several fungal infections have not been recognized soon enough by patients and doctors – which has led to at least 12 deaths related to Humira and/or other TNF-alpha blockers such as Cimzia, Enbrel, and Remicade and is requiring manufacturers to submit safety labeling changes that must include strengthened warnings and revisions to medication guidelines after reviewing 240 reports of fungal infections that have been linked to the drugs.

Fungal infections

The FDA states that it has reviewed 240 reports of histoplasmosis, an infection caused by the fungusHistoplasma capsulatum, in patients being treated with Enbrel, Humira, or Remicade. It concluded that:

The majority of the reports involved people in the Ohio River and Mississippi River valleys (the fungus is commonly found in those areas). In at least 21 of the reports, histoplasmosis was initially not recognized by health care professionals, and antifungal treatment was delayed. Twelve of those patients died.

In the case concerning Cimzia, the FDA says that is has, “reviewed one reported case of histoplasmosis in a patient taking Cimzia...[and] has received reports of cases of coccidioidomycosis and blastomycosis, including deaths, in patients treated with TNF blockers.

Mayo Clinic study

A Mayo Clinic study reports that there a link between the use of Humira and the increased likelihood of developing several types of cancer including skin cancer, gastrointestinal cancer, breast cancer and lung cancer or serious infections. In fact, the study says that those taking Humira were three times as likely to develop cancer and two times as likely to develop a serious infection.

If you've been injured due to one of these TNF-alpha blockers, contact a products liability attorney to discuss your situation and evaluate your options.