Humira (adalimumab) is commonly used for the treatment of rheumatoid arthritis, Crohn’s disease, psoriasis, ulcerative colitis, and many other autoimmune diseases, has been linked to life-threatening side effects. The FDA has issued several safety warnings. Side effects include infections, cancer, Hepatosplenic T-Cell Lymphoma, liver damage, nerve damage, and more.
UPDATE: $2.2 Million Awarded in Humira Infection Lawsuit
May 10, 2013 — Yesterday, a jury in Illionois awarded plaintiff Milton Tietz more than $2.2 million in compensation and punitive damages against Abbott Laboratories. The lawsuit was filed on behalf of his wife, who suffered a life-threatening histoplasmosis infection after taking Humira for less than seven months. Click here to read more.
August 29, 2012 — After FDA staff recommended against approving Humira for ulcerative colitis, an outside panel of experts has recommended support for the new approval. The FDA staff were concerned that Humira is less than 10% more effective than a placebo for treating ulcerative colitis, and yet increases the patient’s risk of several aggressive cancers, nerve damage, infections, and other life-threatening side effects.
Humira (adalimumab) is prescription drug made by Abbott Pharmaceuticals, and received FDA approval in 2003 to treat rheumatoid arthritis. Since then, it has gained approval for other autoimmune diseases. It works by inhibiting a certain group of cells in the body that are responsible for inflammation. Since its approval for arthritis, it has been approved to treat Crohn’s disease (inflammation of the bowels) and psoriasis (inflammation of the skin), and other autoimmune disorders. Humira has been wildly successful. Global sales in 2010 exceeded $6.5 billion.
Humira lawsuits have been filed by people who took this medication and developed severe injuries, including:
Humira and Cancer
Humira belongs to a class of medications called “tumor necrosis factor-blockers,” which blocks the body’s cancer-destroying cells, and also suppresses the body’s immune system.
What types of cancer has Humira been linked to?
- Non-melanoma skin cancer
- Melanoma skin cancer
- Gastrointestinal cancer
- Lung cancer
- Breast cancer
- Hepatosplenic T-Cell Lymphoma
Many young people use Humira to treat juvenile arthritis, Crohn’s disease, and ulcerative colitis. The FDA recently issued a safety communication because it is continuing to receive reports of young people developing a rare cancer of the white blood cells called Hepatosplenic T-Cell Lymphoma. This is a very dangerous, aggressive form of cancer.
The FDA now warns consumers of the risk of developing cancer. When the drug-maker conducted clinical studies to determine whether Humira was safe for consumers to use, it based its safety information on research of only 2,070 patients. Several of these people developed cancer, and one died. The rate of developing cancer was significantly higher than for placebo treatment, but this information was not included in the initial safety warnings.
In 2006, a study by the Mayo Clinic found that people who take this medication are three times more likely to develop cancer. Furthermore, they found that people who take high doses are more than four times more likely to develop cancer.
Humira and Nerve Damage
Humira has been linked to peripheral neuropathy, which is a permanent degeneration of the nerve fibers. The result is that people experience numbness, tingling, or constant pain. This can be extremely debilitating. Some people with nerve damage also have serious muscle problems, organ damage, incontinence, and sexual problems.
The research evidence linking Humira to nerve damage is based on a study conducted by researchers at Angers University in France, which was published in 2006. Though this evidence came out before Abbott Laboratories re-launched Humira in 2007 for the treatment of Crohn’s disease, this new information about nerve damage was not included in the safety labeling.
Humira and Infection
Humira works by inhibiting the body’s own autoimmune responses. This decreases the body’s ability to fight infections, and people who take this medication are at a significantly higher risk of suffering pneumonia, sepsis, tuberculosis, histoplasmosis, and fungal infections.
The Journal of the American Medical Association found that people who take Humira are twice as likely to develop an infection, such as tuberculosis or pneumonia.
These infections include opportunistic fungal infections. Although the medication was known to depress a person’s autoimmune system, the FDA sent a warning to a company because they did not clearly place this in the safety information. A warning about Invasive Fungal Infections did not appear until 2009, after an FDA mandate.