Accutane May Lead to IBD, Crohn’s or Ulcerative Colitis

Accutane lawsuits are being filed across the country against its drugmaker, Hoffman-LaRoche, currently known as Roche Laboratories.  There is a direct link between Accutane and Inflammatory Bowel Disease (IBD), Ulcerative Colitis, or Crohn’s Disease.

Accutane was approved in 1982 by the U.S. Food and Drug Administration (FDA) to treat severe acne, and is classified as a retinoid. The main ingredient in Accutane is isotretionoin, derived from vitamin A. It works by drying up sebum (oil) produced by the skin glands. When too much sebum is produced, it leads to bacteria, inflaming the skin follicles, leading to acne. Generics are also available for Accutane, known as Amnesteem (from Genpharm and Mylam), Claravis (from Teva-Barr), and Sotret (from Ranbaxy).

But as productive as Accutane is, both as a moneymaker and a therapy, it also has the potential to destroy lives. Because of its exceptional power to cure acne, Accutane had been praised as a “miracle drug” by the FDA when it was first introduced.

However, Accutane has been associated with several, serious side effects for many years. There is currently a Black Box warning cautioning consumers about the potential to unborn children, which is the highest warning label the FDA can designate. There are additional, serious side effects, including depression, IBD, liver disease, Crohn’s disease, and ulcerative colitis.

Inflammatory bowel disease, Crohn’s disease, and ulcerative colitis affect more than a million Americans, for which there is no cure.  Symptoms vary for each of these specific diseases, but abdominal pain and cramping are common in all of them. Many patients experience diarrhea, sometimes with blood, fatigue, poor appetite, fever, irritation of the intestines, pain in the joints, skin conditions, and in severe cases, surgery is necessary to remove the affected area. Treatment for these conditions require dietary changes, anti-inflammatory medications, antibiotics if bacteria is present, and at times, immunosuppressants may be necessary. In the worst of cases, surgery would be the only solution.

In a retrial, a New Jersey jury has awarded $25.16 million (nearly 10 times the original award) to an Alabama man with inflammatory bowel disease.  The jury ruled that Roche Laboratories failed to warn Andrew McCarrell’s doctor about the risk of IBD from its Accutane drug. He was a 24 year-old college athlete when he began Accutane to treat his acne. Shortly after discontinuing the drug, he developed chronic ulcerative colitis and within a year had to have his colon removed. He was originally awarded $2.62 million in damaged by a jury, but the verdict was reversed on appeal and remanded for a new trial. Although McCarrell was “very happy” with the verdict, his lawyer added that in view of all he has been through, “nobody in their right mind would change places with Andy.”

So far, six plaintiffs have won a total of $56 million in damages over allegations that Roche knew, or should have known, about the risks of IBD from Accutane. Many other verdicts are being appealed, and there are currently over 7,000 Accutane lawsuits pending in N.J. state court.

Nobody in their right mind would opt for the risk of developing IBD, Crohn’s, or Colitis, just to get rid of a few pimples. That being the case, it should be left up to the consumers to decide whether they want to take this risk. But, because Roche Laboratories decided not to warn of these risks, many people are left debilitated, stuck with an inflammatory disease of which there is currently no cure. Is this justice?

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