May 11, 2010

Accutane, manufactured by Roche, is a drug used to treat severe acne.  Isotretinoin, the generic form, is marketed by other companies under the names Amnesteem, Claravis, Clarus, Decutan, Isotane, Izotek, Oratane, Sotret, Isotrex, and Isotrexin.  Accutane has been associated with a number of side effects including headaches, blurred vision, dizziness, nausea, vomiting, seizures, stroke, diarrhea, depression, and suicide.  Recent studies have linked Accutane to Crohn’s disease and ulcerative colitis collectively known as Inflammatory Bowel Disease.   Ulcerative colitis generates inflammation and ulcers in the lining of the rectum and colon where cells have been killed which then bleed and produce a discharge.  Frequently this disruption of cellular material causes continued diarrhea.  Common symptoms include: bloody diarrhea, rectal bleeding, abdominal cramping, and an urgent need to go to the bathroom.  On the other hand, Crohn’s disease causes a deeper inflammation that can spread through the digestive system including the small intestine, mouth, esophagus, and stomach.  Common symptoms of Crohn’s disease include abdominal cramping and diarrhea.  Inflammatory Bowel Disease generates a higher risk of colon cancer than is observed in the general population.  This disease is an autoimmune disease that causes the body’s own immune system to attack the gastrointestinal system causing inflammation (swelling) and can lead to intestinal blockage.

FDA Requires Changes to Accutane Label

The FDA has required Roche to change their warning label many times since it was introduced on the market in 1982.  The newest warning involves Inflammatory Bowel Disease.  The FDA Accutane warning label says: “Accutane has been associated with inflammatory bowel disease (including regional ileitis) in patients without prior history of intestinal disorders.  In some instances, symptoms have been reported to persist after Accutane treatment has been stopped.  Patients experiencing abdominal pain, rectal bleeding or severe diarrhea should discontinue Accutane immediately.”  There is no known cure for some types of Inflammatory Bowel Disease but there are therapies that attempt to control the symptoms.  One approach to this problem is immunosuppression, in which steroids are used.  In severe cases surgery may be required.  The surgery may involve resection of the bowel, partial removal of the colon, or complete colon removal.  Even though this disease can be treated in terms of symptoms, the patient must live with the fact that the disease is incurable, generating lifelong complications.  Many of the symptoms of this disease are socially unacceptable, causing awkward and embarrassing moments for these individuals.

If you have experienced Inflammatory Bowel Disease, or any other Accutane side effect you may be entitled to financial compensation. Accutane lawsuits are currently being filed across the country.


Susan Ardizzoni, Ph.D. holds a Doctorate in Biology with a major in Neuroscience (medical) and minors in Biochemistry, Physics, and Mathematics with experience in basic and clinical research.  Although the author is not an attorney, this article was sponsored by the law firm of Bernstein Liebhard LLP and constitutes Attorney Advertising.  To learn more about Inflammatory Bowel Disease or FDA Accutane warning please visit

Published November 17, 2011 by