FDA Gives Humira Initial Approval as Ulcerative Colitis Drug

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FIRST PERSON | Medical reviewers have given the nod to expanding the use of a current drug to treat ulcerative colitis. The medication, Humira, is already a treatment for several other inflammatory conditions. While the initial approval is exciting news for some patients, it probably won't change the mind of those such as myself who have already decided not to take the drug for any approved use.

According to Medical News Today, an advisory panel of the U.S. Food and Drug Administration (FDA) has recommended that the agency authorize Humira to treat ulcerative colitis. Pharmaceutical giant Abbott Laboratories, already looking at Humira sales of more than $9 billion a year, hopes the FDA will give approval by the end of 2012.

Medicines.ie lists Humira as a treatment for a number of conditions such as rheumatoid arthritis, Crohn's disease, plaque psoriasis, ankylosing spondylitis, and juvenile idiopathic arthritis. Although the medication has not yet received final approval for ulcerative colitis, it already appears on the list as effective for patients with moderate to severe disease.

Ulcerative colitis and Crohn's disease are the two primary types of inflammatory bowel disease. While Crohn's occurs anywhere in the digestive tract, its first cousin is limited to the large intestine and the rectum. Although ulcerative colitis affects only the innermost lining of the bowel, Crohn's affects all layers. As many as 700,000 ulcerative colitis patients reside in the United States, according to the Crohn's & Colitis Foundation of America.

Humira is the brand name for Adalimumab. A patient injects the drug at specified intervals. Based on the theory that an overactive immune system causes inflammation, the drug suppresses immunity. When my doctors began talking about prescribing the drug to combat stubborn Crohn's disease, I looked at the side effects listed by drugs.com.

What I found was disturbing. In addition to serious infections, I noted potential occurrences of lymphoma, neurological problems, and even complications in the gut. My doctor said I would need a negative tuberculosis test before receiving Humira. He also noted that I had contracted histoplasmosis, a fungal infection, as a child and mentioned the drug warnings related to that condition. I decided Humira was not for me.

The FDA Advisory Panel that gave the initial approval voted 15 to 2. I have to wonder why two members voted against it.

In November 2011, the FDA turned down Abbott's application for expanded use of this medication. The agency said that clinical trials offered no compelling evidence of eradicating the symptoms of ulcerative colitis.

As a matter of fact, when compared with a placebo, Humira produced only slighter better results. Experts question the significance of the difference. If the FDA gives final approval to Humira for treating ulcerative colitis, patients with that condition will have a lot to ponder before deciding whether to try the medication.

Vonda J. Sines has published thousands of print and online health and medical articles. She specializes in diseases and other conditions that affect the quality of life.

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