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FDA Advisory Panel to Consider Humira Approval for Ulcerative Colitis

August 28, 2012 – An independent advisory panel to the U.S. Food & Drug Administration (FDA) is set to meet today to discuss whether to extend approval for Abbott Laboratories’ popular arthritis drug Humira (generic: adalimumab) to include the treatment of ulcerative colitis (UC). However, previous staff reports have suggested that the medication may not be effective in treating UC, and that additional studies should be conducted before the agency warrants approval for this indication. Humira has generated a considerable amount of controversy as of late, as it has recently been linked to serious side effects including tuberculosis, malignancies, Hepatitis B virus reactivation, neurological reactions and heart failure.

Free Humira Lawsuit Evaluation: If you or a loved one has been injured by Humira, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of Humira and we can help.

What’s the problem?

Abbott is seeking extended approval for Humira, which is currently authorized by the FDA to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, moderate to severe chronic psoriasis, and juvenile idiopathic arthritis. But in documents prepared by FDA staff in advance of today’s meeting, concerns were raised about whether a minimal difference in effectiveness (less than 10%) between a placebo and Humira for UC treatment was enough to warrant approval for such a use. Last year, the administration rejected Abbott’s initial bid to garner approval for Humira to treat UC, citing the drug’s ineffectiveness at relieving symptoms such as diarrhea, rectal bleeding, abdominal pain, fever and fatigue.

Ulcerative Colitis is a type of inflammatory bowel disease (IBD) in which the lining of the digestive tract becomes inflamed, causing severe diarrhea and abdominal pain. The inflammation associated with UC usually only affects the innermost lining of the large intestine (colon) and rectum. Like Crohn’s disease, another form of IBD, ulcerative colitis can be both painful and debilitating, and may sometimes lead to serious, life-threatening health complications.

First approved by the FDA in 2002, 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.

Yet despite its considerable effectiveness at treating the conditions it is currently approved for, Humira has recently been linked to the following serious side effects:

  • opportunistic infections
  • tuberculosis
  • malignancies
  • Hepatitis B virus reactivation
  • neurological reactions
  • heart failure
  • Hepatosplenic T-Cell Lymphoma

If the FDA ultimately decides in favor of approving Humira for the treatment of ulcerative colitis, it could net Abbott over $1 billion in additional sales each year. The company is also currently testing Humira’s ability to treat other conditions, such as pediatric Crohn’s disease.

Do I Have a Humira Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Humira lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases in all 50 states.

Free Humira Lawsuit Evaluation: If you or a loved one has been injured by Humira, you should contact our law firm immediately. You may be entitled to compensation by filing a Humira injury suit and we can help.

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