| アブストラクト | INTRODUCTION: Lawyer-submitted reports may have unintended consequences on safety signal detection in spontaneous adverse event reporting systems. OBJECTIVE: Our objective was to assess the impact of lawyer-submitted reports primarily for one adverse event (AE) on the ability to detect a signal of disproportional reporting for another AE for the same drug in the US FDA Adverse Event Reporting System (FAERS). METHODS: FAERS reports from January 2004 to September 2015 were used to estimate yearly cumulative proportional reporting ratios (PRRs) for three known drug-AE pairs-isotretinoin-birth defects, atorvastatin-rhabdomyolysis, and rosuvastatin-rhabdomyolysis-with and without lawyer-submitted reports. Isotretinoin and atorvastatin have been the subject of high-profile tort litigation regarding other AEs. A lower bound of the 95% confidence interval (CI) of one or more based on three or more reports defined a signal. RESULTS: Cumulative PRRs met signaling criteria in all analyses. For isotretinoin, lawyer-submitted reports increased PRRs for birth defects before 2008, with the largest increase in 2006 (2.9 [95% CI 2.4-3.5] to 3.3 [95% CI 2.8-3.9]); lawyer-submitted reports decreased PRRs for birth defects after 2011, with the largest decrease in 2013 (2.2 [95% CI 2.0-2.5] to 1.9 [95% CI 1.7-2.1]). For atorvastatin, lawyer-submitted reports reduced PRRs for rhabdomyolysis after 2013, with the largest decrease in 2015 (18.0 [95% CI 17.1-19.1] to 15.4 [95% CI 14.5-16.2]). Lawyer-submitted reports had little impact on PRRs for rosuvastatin and rhabdomyolysis. CONCLUSIONS: Inclusion of lawyer-submitted reports in FAERS did not meaningfully distort known safety signals for two drugs subject to high-profile tort litigation for other AEs. |
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| ジャーナル名 | Drug safety |
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| Pubmed追加日 | 2018/8/2 |
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| 投稿者 | Rogers, James R; Sarpatwari, Ameet; Desai, Rishi J; Bohn, Justin M; Khan, Nazleen F; Kesselheim, Aaron S; Fischer, Michael A; Gagne, Joshua J; Connolly, John G |
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| 組織名 | Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine,;Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street,;Suite 3030, Boston, MA, 02120, USA.;Department of Biomedical Informatics, Columbia University, New York, NY, USA.;Suite 3030, Boston, MA, 02120, USA. jgagne@bwh.harvard.edu. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/30066315/ |
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