TNF blockers include the drugs Remicade, Enbrel, Humira and Cimzia. These are commonly used to treat rheumatoid arthritis. Problems concerning the drugs first surfaced in 2005 and 2006 with reports of increased risks of certain types of cancers including lymphoma. There have also been reports of serious side effects, including heart failure and serious infections such as tuberculosis, histoplasmosis, listeriosis, and pneumocystosis. The FDA
has issued a series of warnings and now requires the drug to carry a special "black box warning" on its label, a heightened warning for potentially dangerous drugs.
On September 4, 2008, the FDA ordered a stronger warning for these drug. The FDA has ordered that the manufacturer's must warn users that they are at risk of developing potentially fatal fungal infections. In its announcement the agency reports that 240 users of the drugs have contracted a fungal infection called histoplasmosis. 45 of the reported cases have resulted in death.
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 were observed.
These drugs have also been linked with significantly increased risks for developing certain cancers particularly in children. Remicade is approved to treat Crohn's disease in children. While Enbrel and Humira have been approved to treat juvenile rheumatoid arthritis. Enbrel may be used by children as young as 2. Amgen is now seeking FDA approval of Enbrel to treat psoriasis in children.
A study by the Mayo Clinic using pooled data from randomized clinical trials, found that adults given Humira or Remicade to treat rheumatoid arthritis had 2.4 times the cancer rate of those in the control groups. Now the FDA states that it has received reports of 30 cases of cancer over 10 years among children and young adults treated with these drugs. More studies are underway.
Usage:
Remicade (Infliximab), developed by Centocor, a pharmaceutical company owned by Johnson & Johnson; Humira, sold by Abbott Laboratories; Enbrel by Amgen, Inc. and Wyeth; and Cimzia by UCB are drugs used to control inflamation due to auto-immune disorders. Remicade, Humira and Enbrel had combined sales of more than $13 billion last year.
Litigation:
Our affiliated attorneys are currently investigating claims on behalf of victims and their families, for those who died or who suffered from fungal infections or cancer following the use of these medications. If you or a loved one has suffered an injury or any of the side effects listed above while taking these drugs, please use the form at right to contact us today. An experienced attorney is prepared to help protect your legal interests and will contact you within 24 hours.
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