Possible association between isotretinoin and inflammatory bowel disease.
OBJECTIVE
The Physician's Desk Reference lists inflammatory bowel disease (IBD) as a possible adverse event associated with the use of isotretinoin, a popular acne prescription medication. Our aim was to perform a systematic examination of reports of IBD associated with isotretinoin use.


METHODS
All reports filed with the Food and Drug Administration (FDA) via the MedWatch system were requested and reviewed. Strength of causality was determined using the Naranjo adverse drug reaction (ADR) probability scale.


RESULTS
All of the adverse reports filed with the FDA between 1997 and 2002 were accessed and reviewed. Eighty-five cases of IBD associated with isotretinoin use were reported. According to the Naranjo ADR probability scale, 4 cases (5%) scored in the "highly probable" range for isotretinoin as the cause of IBD, 58 cases (68%) were "probable," 23 cases (27%) were "possible," and no cases were "doubtful."


CONCLUSIONS
In a subgroup of patients, isotretinoin might serve as a trigger for IBD.
Reddy
Deepa
D
Department of Medicine, University of Chicago, Chicago, Illinois, USA.
Siegel
Corey A
CA
Sands
Bruce E
BE
Kane
Sunanda
S
D000152:Acne Vulgaris / Q000188:drug therapy; D016907:Adverse Drug Reaction Reporting Systems; D005260:Female; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000139:chemically induced*; D015474:Isotretinoin / Q000009:adverse effects*; D007641:Keratolytic Agents / Q000009:adverse effects*; D008297:Male; D014481:United States; D014486:United States Food and Drug Administration
D007641:Keratolytic Agents; D015474:Isotretinoin