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No link between isotretinoin use, risk for IBD
Women receiving isotretinoin therapy for recalcitrant nodulocystic acne are not at increased risk for developing IBD, according to recent results.
In a case-control study, researchers evaluated 2,159 women with IBD, along with 43,180 matched controls, aged 18 to 46 years. All participants had received one or more prescriptions for oral contraceptives between May 2001 and December 2009. Use of isotretinoin in both groups was recorded to assess its impact on the risk for IBD. Investigators also performed a meta-analysis of five studies measuring the relationship between isotretinoin and IBD.
Isotretinoin exposure was observed in 0.46% of patients with IBD, including five cases each of ulcerative colitis and Crohn’s disease; along with 0.44% of controls. Researchers calculated an adjusted RR of 0.99 (95% CI, 0.52-1.90) for IBD among isotretinoin users, with similar RRs for Crohn’s disease (0.91; 95% CI, 0.37-2.25) and ulcerative colitis (1.10; 95% CI, 0.44-2.70). A longer duration of isotretinoin use was not associated with increased IBD risk, with RRs of 0.96 (95% CI, 0.87-1.05) for an additional 30 days and 0.87 (95% CI, 0.66-1.16) after an extra 90 days. Intentionally misclassifying a random ulcerative colitis case as Crohn’s disease altered the RRs to 0.87 (95% CI, 0.32-2.36) for ulcerative colitis and 1.11 (95% CI , 0.49-2.54) for Crohn’s disease.
In addition to the current study, the meta-analysis included four additional studies (three published) and resulted in pooled RRs of 0.94 (95% CI, 0.65-1.36) for IBD, 0.75 (95% CI, 0.46-1.24) for Crohn’s disease and 1.61 (95% CI, 0.88-2.95) for ulcerative colitis.
“The results of this study are consistent with other published studies that do not suggest an increase in the risk for IBD with isotretinoin use. Given the high burden of psychological stress associated with cystic acne in adolescents and young adults, clinicians should not be discouraged from prescribing isotretinoin therapy to their patients owing to concerns of an unproven association with IBD.”
Disclosure: Researcher Steven T. Bird, PharmD, MS, is an FDA employee.