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J Am Acad Dermatol. 2013 Sep;69(3):393-8. doi: 10.1016/j.jaad.2013.04.031. Epub 2013 May 14.

Alleged isotretinoin-associated inflammatory bowel disease: disproportionate reporting by attorneys to the Food and Drug Administration Adverse Event Reporting System.

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1
Center for Study of Complex Diseases, Research Institute, Evanston, and Gastroenterology Department, Highland Park, NorthShore University HealthSystem, Illinois, USA.

Abstract

BACKGROUND:

Some studies have purported to link isotretinoin prescribed for acne with the development of inflammatory bowel disease (IBD).

OBJECTIVE:

We sought to identify existence of disproportionate attorney-initiated reporting of isotretinoin-associated IBD in the Food and Drug Administration Adverse Event Reporting System (FAERS).

METHODS:

A total of 3,338,835 cases (2003-2011) were downloaded from the FAERS. These were queried for IBD cases reported with isotretinoin for a usage indication of acne while recording reporter category. Trends were analyzed over time for reports by attorneys for all medications compared with reports of IBD with isotretinoin. Signal inflation factor was calculated to determine the distortion of pharmacovigilance signals for IBD with isotretinoin.

RESULTS:

There were 2214 cases of IBD resulting from isotretinoin. Attorneys reported 1944 (87.8%) cases whereas physicians reported 132 (6.0%) and consumers reported 112 (5.1%) cases (P value < .01). For the entire FAERS, only 87,905 of the total 2,451,314 (3.6%) reports for all drug reactions during the same time period were reported by attorneys (P value < .01). The signal inflation factor for IBD with isotretinoin for attorney-initiated reports was 5.82, signifying a clear distortion.

LIMITATIONS:

The accuracy of reports was not ascertained.

CONCLUSIONS:

Attorney-initiated reports inflate the pharmacovigilance signal of isotretinoin-associated IBD in the FAERS.

KEYWORDS:

FAERS; FDA; Food and Drug Administration; Food and Drug Administration Adverse Event Reporting System; IBD; VAERS; Vaccine Adverse Event Reporting System; acne vulgaris; acne vulgaris/drug therapy; dermatologic agents/adverse effects; inflammatory bowel disease; inflammatory bowel diseases; inflammatory bowel diseases/chemically induced; isotretinoin; postmarketing; product surveillance

PMID:
23683730
DOI:
10.1016/j.jaad.2013.04.031
[Indexed for MEDLINE]

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