Accutane & Inflammatory Bowel Disease (IBD)

In August 2006, the results of a study published in the American Journal of Gastroenterology confirmed that the acne drug Accutane (isotrentinoin) causes an increased risk to its users of developing a potentially serious intestinal condition called inflammatory bowel disease (IBD). The study was conducted by a team of medical doctors at Dartmouth-Hitchcock Medical Center in New Hampshire. Accutane, approved by the U.S. Food and Drug Administration (FDA) in 1982, is manufactured by Hoffmann-La Roche.

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What is IBD?

IBD is a group of inflammatory conditions of the intestines. The main forms of the condition are Chrohn?s disease and ulcerative colitis. Although rarely fatal on its own, people who develop IBD usually suffer a limited quality of life due to the pain, liver problems, arthritis, vomiting, weightloss, and other troubling symptoms of the disease. Those with IBD also have an increased risk of colorectal cancer.

The study linking Accutane to IBD was comprised of a review of all reports of Accutane-associated IBD that were submitted to the FDA through the agency?s MedWatch system since it the program began in 1996. The study determined that between 1997 and 2002 a total of 85 suspected Accutane related cases of IBD were reported. The researchers used a standard adverse drug reaction probability scale to gauge the likelihood that a particular IBD condition was caused by the use of Accutane. In four cases, Accutane was graded as the ?highly probable? cause, by the researchers, while 58 cases were deemed a ?probable? cause, and in 23 cases it was listed as a ?possible? cause. None of the links between Accutane and IBD were graded in the category labeled ?doubtful?.

The researchers who conducted the study cautioned that ?physicians and patients should be made aware of this possible association and it should be included in the already extensive consent process required before isotrentinoin is prescribed.?

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A warning about IBD has been added to Accutane's product label

IBD is now listed as a warning on Accutane?s product information label, noting that symptoms have been reported to persist after use of Accutane has ceased. The warning also states that Accutane users who experience abdominal pain, rectal bleeding or severe diarrhea should stop using Accutane immediately. Additionally, Accutane?s medication guide states, ?certain symptoms may mean that your internal organs are being damaged. These organs include the liver, pancreas, intestines, and esophagus (connection between mouth and stomach). If your organs are damaged, they may not get better even after you stop taking Accutane.?

The addition of an IBD warning to Accutane?s product label joins numerous other warnings of adverse effects associated with the drug, including birth defects and severe psychiatric problems.

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Have you used Accutane?

If you or a member of your family has experienced severe side effects while using Accutane, such as inflammatory bowel disease, and you would like to speak to a professional regarding your rights, please fill out this short form and an experienced member of Seeger Weiss?s staff will contact you. Initial consultations are free of charge and do not create a legal relationship. Seeger Weiss LLP has offices located in New York and New Jersey and its attorneys are available to practice in courts throughout the country.