Accutane Side Effects May Quadruple Risk of Ulcerative Colitis: Study

The results of a new study add to the evidence that the side effects of Accutane, an acne drug that is also known as generic isotretinoin, may increase the risk of developing bowel problems. 

The study, conducted by researchers at the University of North Carolina Chapel Hill, was published March 30 in the American Journal of Gastroenterology. Researchers say they found that the use of Accutane increased the risk of developing ulcerative colitis by a factor of four.

Researchers looked at data from 87 health insurance plans and found nearly 8,200 people who had been diagnosed with inflammatory bowel disease (IBD), which is a group of digestive disorders that includes ulcerative colitis and Crohn’s disease.

They found that not only were those taking Accutane four times more likely to develop ulcerative colitis, but they also determined that the chance of developing the bowel disorder rose in relation to the size of the Accutane dose, strengthening the evidence of a causal relationship. However, the researchers note that the findings do not prove a causal relationship between Accutane and ulcerative colitis, and said that even if there is a risk, the chance of developing ulcerative colitis is small.

The findings come a little more than a month after a New Jersey jury awarded an Alabama man $25.16 million in an Accutane lawsuit against Roche that claimed the drug caused him to develop IBD.

Roche faces nearly 1,000 lawsuits over Accutane, which has been associated with bowel problems, depression and birth defects. All of the lawsuits include allegations that Roche failed to adequately warn users about potential Accutane side effects. The company has lost all six cases that have gone to trial so far, with jury awards totaling $56 million. One of those verdicts, with a $7.2 million award, has been overturned by a Florida appeals court.

Accutane has been used by more than 16 million people worldwide since it was first introduced in the early 1980s as a treatment for severe acne. An Accutane recall was issued by Roche in June 2009, citing the cost of defending Accutane injury suits as a factor in the decision to discontinue the medication in the United States.

In February, Health Canada issued a warning that it has received numerous reports of severe skin reactions, including sometimes fatal reaction known as Stevens-Johnson Syndrome from Accutane. At least 66 reports of Accutane skin reactions were identified by Health Canada, including adults and children, with two of the cases resulting in death.

Stevens-Johnson syndrome (SJS) is a severe skin reaction that occurs as a side effect of several medications. It is highly debilitating and causes the skin to burn from the inside out, producing blisters, severe rashes and the skin may begin to separate from the body. When the skin lesions affect more than 30% of the body, the condition is referred to as Toxic Epidermal Necrolysis (TEN). Treatment in a hospital Intensive Care Unit (ICU) or Burn Unit is often required, and the conditions can be fatal in many cases.