Accutane, a drug prescribed to treat severe acne, has been linked to serious side effects such as
- Inflammatory bowel disease (IBD)
- Ulcerative colitis
- Crohn’s disease
- Stevens-Johnson Sydrome (SJS)
- Erythema multiforme (EM)
- Severe birth defects
IBD is a condition that involves the swelling of the intestines. It causes one of two diseases: ulcerative colitis or Crohn’s disease.
Ulcerative Colitis is a swelling of the colon. It also causes ulcers in the lining of the intestine wall.
Crohn’s disease refers to swelling in a person’s small intestine and some parts of the large intestine. The swelling reaches further into the intestinal wall than ulcerative colitis. Sometimes the entire bowel is overwhelmed with Crohn’s disease.
What is Accutane?
Accutane (generic: isotretinoin) is a medication that was developed by the Hoffman LaRoche Company for treatment of severe acne (also called nodular acne). The FDA approved Accutane in 1982 and, since then, about five million Americans have been treated with it. Accutane remained on the market for 27 years until its recall in June of 2009.
Lawsuits against Roche allege that they failed to adequately warn Accutane users about the potential risk of inflammatory bowel disease (IBD), which can lead to ulcerative colitis, Crohn’s disease, or other damage to internal organs.
Accutane was placed in Pregnancy Category X, the most severe pregnancy risk the FDA can attach to a drug. X drugs should not be taken by pregnant women due to their propensity to cause terrible birth defects. Sexually active users of Accutane were required to use two forms of birth control and to discontinue use of Accutane at the first possibility of pregnancy.
Research Against Accutane
In March 2010, a study from the University of Carolina Chapel Hill was published in the American Journal of Gastroenterology linking isotretinoin to IBD, which causes ulcerative colitis and Crohn’s disease. The study found Accutane users to be four times more likely to develop ulcerative colitis.
Health Canada issued a public health alert regarding the association of Accutane and skin reactions, including erythema multiforme (EM), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). These issues can be severe and, in worst cases, fatal. Health Canada researched the Roche global safety database to find the connection between Accutane and the skin reactions. Currently, no claims have been filed against Accutane for these skin reactions.
In June 2009, Hoffman LaRoche Company removed Accutane from the United States and 11 other markets. Roche cited business reasons related to low market share coupled with the high cost of defending personal-injury lawsuits brought by users of Accutane. The recall immediately followed Roche’s loss of a $33 million lawsuit.
Following the first lawsuit filed in September 2004, there have been 3,000 Accutane claims filed as of February 2011. Six settlements have been reached totaling $56 million. All six trials and the pending lawsuits involve claims that users of Accutane were not sufficiently warned about the potential risk of inflammatory bowel disease and the issues it can lead to including ulcerative colitis, Crohn’s disease and other damage to internal organs.
What You Can Do
If you or a loved one has suffered serious injury as a result of Accutane usage, contact Heygood, Orr & Pearson for a free consultation so we can help you determine the best way to protect your legal rights and interests.