| アブストラクト | AIM: Patient-reported outcomes associated with adverse events (AEs) reported with generics have not been evaluated. To map AEs associated with generics to the NIH Patient-reported Outcomes Measurement Information System. METHODS: We mapped 381 AEs from 148 case reports of generic tamsulosin, levothyroxine and amphetamine/dextroamphetamine to the physical, mental and social domain of the NIH Patient-Reported Outcomes Measurement Information System after reviewing 1237 case reports in the US FDA's Adverse Event Reporting System (FAERS; 2011-2013). RESULTS: 75%, 76% and 71% reports were classified under the physical domain for tamsulosin, levothyroxine and amphetamine/dextroamphetamine, while 9%, 9% and 18% reports were classified under the mental domain, respectively. CONCLUSION: FAERS reveals several domains of patient-relevant concerns associated with generic drugs. |
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| 組織名 | Center for Drug Safety & Effectiveness, Johns Hopkins Bloomberg School of Public;Health, MD 21205, USA.;Division of Clinical Pharmacology, Johns Hopkins School of Medicine, Baltimore,;MD 21287, USA.;Doctoral Student in Population Health Sciences, Harvard University, Boston, MA;02115, USA.;Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, MD;21205, USA.;Division of General Internal Medicine, Johns Hopkins University School of;Medicine, MD 21287, USA.;Department of Medicine, University of Massachusetts Medical School, Worcester, MA;01655, USA. |
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