TY - JOUR
T1 - A causal association between isotretinoin and inflammatory bowel disease has yet to be established
AU - Crockett, Seth D.
AU - Gulati, Ajay
AU - Sandler, Robert S.
AU - Kappelman, Michael D.
PY - 2009/10
Y1 - 2009/10
N2 - OBJECTIVES:Case reports have described a possible association between isotretinoin and inflammatory bowel disease (IBD). We critically appraised the literature on this association to assess whether it supports a causal relationship.METHODS:We systematically searched for case reports, case series, and clinical trials assessing this association. We then applied the Hill criteria to evaluate causality.RESULTS:Twelve case reports and one case series reported an association between isotretinoin use and subsequent development of IBD. Cases occurred in seven countries over a 23-year period and differed with respect to reported isotretinoin dose, duration of treatment before development of disease, whether disease developed on or off medication, and clinical presentation of disease. No prospective or retrospective studies have examined the relationship between isotretinoin and IBD. An estimated 59 coincident cases of IBD would be expected in isotretinoin users each year, assuming no increased risk. Alternative explanations may account for the sequence of events seen in case reports. Strength, specificity, and consistency of the association are lacking.CONCLUSIONS:Current evidence is insufficient to confirm or refute a causal association between isotretinoin and IBD. Additional prospective or well-designed retrospective (e.g., case-control) pharmacoepidemiological studies are needed to definitively establish causality.
AB - OBJECTIVES:Case reports have described a possible association between isotretinoin and inflammatory bowel disease (IBD). We critically appraised the literature on this association to assess whether it supports a causal relationship.METHODS:We systematically searched for case reports, case series, and clinical trials assessing this association. We then applied the Hill criteria to evaluate causality.RESULTS:Twelve case reports and one case series reported an association between isotretinoin use and subsequent development of IBD. Cases occurred in seven countries over a 23-year period and differed with respect to reported isotretinoin dose, duration of treatment before development of disease, whether disease developed on or off medication, and clinical presentation of disease. No prospective or retrospective studies have examined the relationship between isotretinoin and IBD. An estimated 59 coincident cases of IBD would be expected in isotretinoin users each year, assuming no increased risk. Alternative explanations may account for the sequence of events seen in case reports. Strength, specificity, and consistency of the association are lacking.CONCLUSIONS:Current evidence is insufficient to confirm or refute a causal association between isotretinoin and IBD. Additional prospective or well-designed retrospective (e.g., case-control) pharmacoepidemiological studies are needed to definitively establish causality.
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U2 - 10.1038/ajg.2009.334
DO - 10.1038/ajg.2009.334
M3 - Article
C2 - 19806085
AN - SCOPUS:70350520126
SN - 0002-9270
VL - 104
SP - 2387
EP - 2393
JO - American Journal of Gastroenterology
JF - American Journal of Gastroenterology
IS - 10
ER -