TNF-alpha blockers such as Remicade, Humira, Enbrel, Cimzia and Simponi are used to suppress the immune system in people who suffer from various forms of arthritis. However, the FDA says that these drugs may cause serious side effects, including death, but many doctors and patients simply don't know it. So, what aren't manufacturers telling you?

Attorney Doug Kreis says manufacturers knew about problems, but didn't warn

According to Florida Attorney Douglass Kreis, these manufacturers have a duty to provide sufficient and clear information to prescribing physicians and the consuming public, but have not fulfilled that duty. He told us:

We believe that the companies which market and sell TNF-αlpha blockers, including Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimuma) and Remicade (infliximab) have long known of the causal relationship between their drugs and fungal infection adverse reactions. However, the adequacy of the warnings provided in the drugs’ labels or package inserts have been the focal point of our investigation and will likely be the issue upon which the cases are decided. Particularly, in situations where the suspected side effect or adverse drug event is as serious as histoplasmosis, the manufacturers’ had a clear duty to provide sufficient and clear information to prescribing physicians and the consuming public.

Another TNF-alpha blocker drug, Simponi, was only approved in April of 2009 as a treatment for adult patients with moderate to severe rheumatoid arthritis in combination with methotrexate, psoriatic arthritis (either alone or in combination with methotrexate) and ankylosing spondylitis. However, the drug has also been linked to fungal infections.

FDA warns of TNF-alpha blocker side effects – again

The U.S. Food and Drug Administration (FDA) issued a warning to doctors and patients who take these drugs to combat various forms of arthritis including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile rheumatoid arthritis, Crohn's disease in adults and children, plaque psoriasis, ulcerative colitis and others in September 2008 and again in May 2009.

Although some manufacturers have sent letters to doctors about the infections, the FDA wants manufacturers to strengthen their current warning labels as many patients and doctors consistently are not identifying fungal infections associated with these drugs in time – which has led to at least 12 deaths.

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.