Humira (adalimumab) is prescribed for rheumatoid arthritis, Crohn’s disease, psoriasis, ulcerative colitis, and other inflammatory disease. The FDA is issuing a safety announcement following increasing evidence linking the medication to many types of cancer, infection, nerve damage, liver damage, and Hepatosplenic T-Cell Lymphoma.
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.
Overview
Humira (adalimumab) is a prescription drug that is manufactured and distributed by Abbott Laboratories. It was initially approved by the FDA in 2003 to treat rheumatoid arthritis, and is now approved for a variety of autoimmune disorders, including Crohn’s disease, ulcerative colitis, and psoriasis. These disorders are all caused by the body’s own autoimmune response, and Humira works by inhibiting these immune cells. It has been the most successful drug for Abbott Laboratories — sales exceeded $6.5 billion in 2010.
Humira Injuries
Serious side effects have made Humira the subject of several lawsuits, filed by people who have suffered the following catastrophic injuries:
- Cancer (lymphoma)
- Nerve damage
- Infections
- Tuberculosis
- Pneumonia
- Histoplastmosis
Humira and Cancer
Humira has been linked to a variety of life-threatening, serious cancers. These include Lymphoma, non-melanoma skin cancer, melanoma skin cancer, gastrointestinal cancer, lung cancer, breast cancer, and Hepatosplenic T-Cell Lymphoma.
The reason people have an increased risk of cancer is because Humira belongs to a class of drugs known as “tumor necrosis factor-blockers,” which inhibit the body’s own cancer-attacking cells in the immune system. The diseases Humira treats are caused by an over-reaction of the body’s immune system, so Humira inhibits these cells. Unfortunately, this action also makes a person susceptible to adverse events, including cancer.
The newest FDA safety communication is in response to continuing reports of young people developing a rare, aggressive, and deadly form of white blood cell cancer called Hepatosplenic T-Cell-Lymphoma.
Many studies have concluded that Humira increases a person’s risk of developing cancer. A 2006 study by the Mayo Clinic found that the rate of developing cancer was significantly higher compared to people taking a placebo. The safety information was based on a study of just 2,070 patients, but several of them developed cancer, and one died. The Mayo Clinic study found that people taking Humira are three times more likely to develop cancer, and if they take high doses, they are more than four times more likely to develop cancer.
Humira and Nerve Damage
Some people who use Humira injections have developed a type of nerve damage called “peripheral neuropathy.” People who suffer from this side effect may experience numbness, tingling, or constant pain. Peripheral neuropathy can also cause severe muscle problems, organ damage, bladder issues, and sexual problems.
Research linking Humira to nerve damage dates back to 2006, when doctors at Angers University in France found a link between nerve damage. Though this information was available, researchers did not include it in the safety information when Humira was re-launched for Chohn’s disease in 2007.
Humira and Infections
People who use Humira to decrease the body’s over-reacting immune system and treat autoimmune disesase may be at an increased risk of developing several types of infections. The risk of suffering pneumonia, sepsis, tuberculosis, histoplasmosis, and fungal infections is greater, according to a study conducted by the Journal of the American Medical Association. This study found that people who take Humira are twice as likely to develop an infection, such as tuberculosis or pneumonia.
Although there was information that Humira increased a person’s chance of developing an infection, a clear safety warning did not appear on the labeling until the FDA mandated chances in 2009.
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