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.
journal_name
J Am Acad Dermatoljournal_title
Journal of the American Academy of Dermatologyauthors
Stobaugh DJ,Deepak P,Ehrenpreis EDdoi
10.1016/j.jaad.2013.04.031subject
Has Abstractpub_date
2013-09-01 00:00:00pages
393-8issue
3eissn
0190-9622issn
1097-6787pii
S0190-9622(13)00423-4journal_volume
69pub_type
杂志文章abstract：:Patients with basal cell carcinoma and solar keratoses were treated with etretinate. Substantial and prolonged clinical improvement was seen. All patients with solar keratoses showed a decrease in the mean area and number of lesions and eight patients demonstrated complete healing clinically. Two patients experienced ...
journal_title：Journal of the American Academy of Dermatology
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doi：10.1016/j.jaad.2004.03.047
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pub_type： 临床试验,杂志文章,随机对照试验
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更新日期：1993-02-01 00:00:00
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pub_type： 杂志文章
doi：10.1016/s0190-9622(99)70375-0
更新日期：1999-08-01 00:00:00
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pub_type： 杂志文章,评审
doi：10.1016/j.jaad.2009.08.026
更新日期：2010-01-01 00:00:00
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pub_type： 杂志文章
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更新日期：2016-07-01 00:00:00
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journal_title：Journal of the American Academy of Dermatology
pub_type： 杂志文章,评审
doi：
更新日期：1999-10-01 00:00:00
