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Humira, an injection medicine prescribed for rheumatoid arthritis, psoriasis, Crohn’s Disease, and other autoimmune diseases, may cause life-threatening side effects, according to the FDA. Patients may suffer permanent nerve damage, cancer, lymphoma, and opportunistic fungal infections.

Overview

What is Humira? Humira is a prescription medicine with many uses, and is usually prescribed to treat autoimmune diseases. Approved uses include as rheumatoid arthritis, psoriasis, and Crohn’s disease. The mediation is manufactured and sold by Abbott Laboratories, which created it as the first “biological” medicine. A biological drug is one that is made from reconstituted substances found in the human body. It is the first FDA-approved biological drug made of human cells. Since the FDA approved it in 2003, it was marketed specifically to treat rheumatoid arthritis, and has become very lucrative. Humira is now FDA-approved to treat five diseases affecting the autoimmune system. Globally, sales topped $6.5 billion in 2010. By 2016, it is projected to become the best-selling medicine in the world.

Humira Lawyer files Humira Lawsuit

Several lawsuits have been filed against the makers of Humira, regarding the following serious side effects:

These lawsuits allege that Abbott Laboratories was aware of safety information, but did not provide consumers with this information by clearly including it in the labels. Furthermore, after the FDA forced the company to update the labels, the drug-maker waited months — for fungal infections, the company waited for more than a year.

Humira and Cancer

Humira is a “tumor necrosis factor-blocker,” which means that it belongs to a class of drugs that works by inhibiting a certain type of cell in the body. These cells play a key role in the autoimmune system, warding off infection. They also fight cancer. Humira actually suppresses the body’s immune system.

As a result of inhibiting the cancer-fighting cells, people taking Humira have an increased risk of developing several types of cancer, including lymphoma, breast, lung, and skin cancer. The clinical study of Humira was small– just 2,070 patients. But during this trial, several people developed cancer, and one died. This safety information was excluded from the labeling when Humira was released, and it was not until 2009 that the FDA forced adequate safety information on the label.

Studies have found that a person taking Humira may be three times more likely to develop cancer.

 

In 2003, the first year Humira was available, the FDA received 365 reports from consumers who had experienced severe adverse side effects, including cancer. Because these were self-reported, the actual number is probably far greater. In addition, a Mayo Clinic research study from 2006 found that Humira increases a person’s chance of developing skin cancer, gastrointestinal cancer, breast cancer, and lung cancer. How long did Abbott Laboratories wait to adequately update the safety information? It waited until 2009.

Humira and Nerve Damage

Humira has also been linked to a type of nerve damage called “peripheral neuropathy,” which causes permanent damage. When people have this side effect, they typically suffer from constant numbness or tingling. It may also cause muscle problems, organ damage, sexual problems, and incontinence. In severe cases, they suffer constant, debilitating pain.

The research linking Humira to nerve damage goes back to 2006, when researchers at Angers University in France found that a person was significantly more likely to suffer nerve damage while taking Humira injections. This information was not included in the safety label in time for the drug’s 2007 release for Crohn’s disease.

Humira and Infections

Humira has also been linked to infections, mostly related to its autoimmune suppression effects. These infections have included life-threatening, severe fungal infections. Though an increased rate of these infections appeared in clinical trials of the drug, the safety information was not put on the label until the FDA required it in 2009.

The Medication Guide to Humira now includes warnings about Invasive Fungal Infections. This was updated in 2009. Before this time, however, it was known that Humira suppressed the immune system.