Humira Lawsuit

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Abbott’s blockbuster TNF Inhibitor drug Humira (adalimumab) has been linked to cancer, nerve damage, and a variety of opportunistic infections. In August 2009, the U.S. Food & Drug Administration (FDA) required that Humira labels carry a ‘black box‘ warning alerting users “… of an increased risk of lymphoma and other malignancies in children and adolescents treated with TNF blockers.” In addition to the black box warning, Humira labels warn of hepatitis B virus reactivation, nervous system problems, blood problems, heart failure, and certain immune reactions.

Humira Overview

First approved by the FDA in 2002, Humira is a Tumor Necrosis Factor (TNF) Inhibitor that is typically prescribed to treat the following conditions:

  • rheumatoid arthritis
  • juvenile idiopathic arthritis
  • psoriatic arthritis
  • ankylosing spondylitis
  • crohn’s disease
  • plaque psoriasis

Humira is designed to work by blocking the activity of tumor necrosis factor-alpha (TNF-alpha), a naturally occurring chemical in the body that is involved in inflammation and a variety of other immune system functions. Patients with inflammatory diseases tend to have higher levels of TNF-alpha in their bodies, which leads to inflammation and a host of other problems. By inhibiting TNF-alpha, Humira aids in relieving the symptoms of these conditions and prevents future damage from occurring. However, it is important to understand that Humira does not cure the conditions it is intended to treat.

Humira Side Effects

Since first being released, federal drug regulators have continuously required Abbott to increase the warnings on Humira labels to more accurately describe the real risks of using the drug. The enhanced warnings are designed to alert the public and medical communities of the risks involved with using this controversial prescription medication. Mounting research and numerous case studies have drawn a link between Humira and the following serious side effects:

  • Tuberculosis
  • Pathogenic viruses
  • Bacterial sepsis
  • Bacterial pathogens
  • Legionella
  • Listeria
  • Fungal infections
  • Histoplasmosis
  • Blastomycosis
  • Coccidioidomycosis
  • Lymphoma
  • Hepatosplenic T-cell lymphoma (HSTCL)
  • Leukemia
  • Skin cancer
  • Hepatitis B infection
  • Liver problems / failure
  • Heart failure
  • Brittle bones / bone fractures
  • Death

It has been found that Humira decreases the body’s ability to fight infection, thus increasing the risk that the user will develop a serious and potentially deadly infection. According to a recent study published in the Journal of the American Medical Association (JAMA), Humira use doubles the risk of developing a serious infection such as tuberculosis or pneumonia.

In 2004, it was announced that Humira increased the risk of life-threatening liver damage that can be so severe that it requires long-term medical treatment and/or liver transplant. A number of Humira users have become extremely ill, and some have even died due to the drug’s side effects.

Humira also poses the risk of localized skin reactions at the injection site. In 2005, Dutch researchers published a study in Arthritis Research and Therapy that found Humira doubles the risk of skin infections, skin eruptions, eczema, and more. The study also found that approximately 25% of patients taking Humira sought medical attention for a skin side effect within two years of taking the drug.

Then in 2006, a study conducted by researchers at the Mayo Clinic found that individuals taking Humira were three times more likely to develop cancer compared to patients from the general public who were not taking the drug. The research identified the cancer risk as being dose-dependent – patients taking higher doses of Humira were nearly five times more likely to develop cancer.

Humira Drug Interactions

Humira has also been reported to have adverse drug interactions with a variety of medications including (but not limited to):

  • Orencia
  • Kineret
  • Remicade
  • Enbrel
  • Cimzia
  • Simponi
  • Rituxan
  • Imuran
  • Purinethol

Risk Factors

Individuals with the following risk factors are more likely to suffer from Humira side effects:

  • history of immune disease such as AIDS, HIV, or cancer
  • history of recurring or chronic infection
  • concurrent use of immunosuppressant drugs
  • old age
  • history of Hepatitis B
  • other underlying conditions

To reduce the risk of Humira side effects, doctors recommend that patients wash their hands frequently, avoid individuals who are sick, and monitor their health condition regularly. If any adverse symptoms develop, you should seek immediate medical attention.

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