There have been concerns that Humira is associated with (1) infection, (2) autoimmune disorders, and (3) an increased risk of cancer. This blog post talks about the potential connection between Humira and Cancer.
We are not handling Humira lawsuits at this time. Honestly, Humira has not really been on our radar screen. I just happened to be reading about the issue today because I was looking at the patent infringement verdict against Abbott involving Humira last year. So I thought I would write about what I learned. Much of this is taken from Humira lawsuits that have been filed against Abbott and other TNF blockers and other research that I did today.
Humira was approved by the FDA in 2002 for treating adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs. Humira, like its Johnson & Johnson competitor Remicade, is a TNF blocker. Humira is described as a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor. Humira binds to TNF and blocks the p55 and p75 cell surface TNF receptors.
Five years later, Humira received an indication for the treatment of Crohn’s disease. At the time, Humira’s label indicated that there may be a potential increase in lymphoma for patients who used Humira.
In June, 2008, the FDA issued an “Early Communication about an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Embrel, Humira, and Cimzia).” The FDA reported that it was investigating approximately 30 reports of cancer occurring in young adults who began taking TNF blockers (along with other immuno-suppressive medicines) when they were ages 18 or less, to treat Juvenile Idiopathic Arthritis (JIA), Crohn’s disease or other diseases.
A month later in Great Britain, Abbott reported to doctors that “since December, 2002, three postmarketing reports of hepatosplenic T-cell lymphoma (HSTCL), which is a rare aggressive form of non-Hodgkin lymphoma, with a poor prognosis, have been reported in patients receiving Humira.” In September 2008, the FDA announced a black box warning was required for Humira. A black box warning is the strongest warning label a drug can have applied to it.
Humira remains on the market today. I’m not saying there should be a recall of this product or that it should not be used by some patients. Certainly, patients should be talking to their doctors about all of the potential issues that impact their decision as to whether or not they should be taking Humira.