A study published in the September 2010 issue of The American Journal of Gastroenterology suggests a link between the use of isotretinoin (the generic version of Accutane) and ulcerative colitis. In the study, 8,189 cases were studied, including 3,664 cases of Crohn's disease and 4,428 cases of ulcerative colitis. A further 21,832 controls were also included in the study and a total of 60 subjects were exposed to isotretinoin.
Researchers found that ulcerative colitis was strongly associated with previous exposure to isotretinoin. They further concluded, "Higher dose of isotretinoin seems to augment this risk," and recommended that prospective patients should be aware of the possible association between isotretinoin and ulcerative colitis.
"The relative risk [of developing ulcerative colitis after using isotretinoin], with a 95 percent confidence interval, was 4.36," Lowe says. "From a plaintiff's perspective, anything that is two or higher is good, because at two, there is a doubling of the risk and the burden of proof is more likely than not."
According to Lowe, the study is important, because in the past, cases have been dismissed in Federal Court early in the litigation before the more recent studies came out and before Hoffman LaRoche withdrew Accutane from the market. Having this study, which provides more evidence of a link between Accutane and ulcerative colitis, should result in more jury verdicts in favor of the plaintiffs, Lowe says.
Although an association was found between Accutane and ulcerative colitis, there was not an association found between Accutane and Crohn's disease.
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"It appears, based on this recent article, that the science is getting better for the plaintiffs, regarding Accutane," Lowe says. "We live and die by the science and the science is getting stronger. There is more support now than there was in 2009 and early 2010 that Accutane is linked to these types of injuries."