Thursday, October 6, 2011

What Qualifies For Accutane Side Effects Trial?

Approved by the Food & Drug Administration (FDA) in 1982, Accutane has been the subject of controversy for years. It first garnered attention in the late eighties for causing severe birth defects. It has also been known to cause psychiatric problems, and has been linked to hundreds of cases of suicide in the United States. Accutane has also been associated with problems of the liver, kidneys, central nervous system, and pancreas, as well as the cardiovascular, musculoskeletal and auto-immune systems. In 2009, Roche decided to stop marketing Accutane for economic reasons. The side effects of Accutane (isotretinoin), and its generic equivalent, have also been linked to an increased risk of Crohn’s disease and Accutane inflammatory bowel disease (IBD).

Accutane Crohn’s disease, which is named for gastroenterologist Burrill Bernard Crohn, who first described the illness in 1932, is an inflammatory disease that effects the large intestine or colon. It is a form of
inflammatory bowel disease, and involves the development of ulcers, or open sores, in the colon. Many users have experienced symptoms of Accutane-induced Crohn’s disease for years before a diagnosis is made, because symptoms may be more vague than ulcerative colitis from Accutane. Crohn’s disease symptoms typically involve: abdominal pain, diarrhea, vomiting and weight loss. There is no known cure for Crohn’s disease and it can have a devastating impact on an individual’s quality of life. Treatment often requires medication and lifestyle changes to reduce symptoms. In severe cases, surgery for Crohn’s disease from Accutane may be necessary, though surgery is not a cure for the disease.

More than 3,000 people have filed a similar Accutane lawsuit against Roche or makers of generic Accutane versions, alleging that they suffered bowel problems as a result of the drug makers’ failure to warn about the potential side effects. Prior to this trial, Roche had lost all six trials that previously reached a jury, with millions of dollars in Accutane damages being awarded to individuals who developed inflammatory bowel disease.  Information contained on the drug’s warning label has been vague and confusing, leaving consumers and physicians unclear on the extent of the risk or the impact of Crohns disease after Accutane use can have on an individual for the rest of their life.

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