Sathiya Priya Marimuthu1,2, Geetha Iyer3, Jodi B Segal1,4,5, Sonal Singh6. 1. Center for Drug Safety & Effectiveness, Johns Hopkins Bloomberg School of Public Health, MD 21205, USA. 2. Division of Clinical Pharmacology, Johns Hopkins School of Medicine, Baltimore, MD 21287, USA. 3. Doctoral Student in Population Health Sciences, Harvard University, Boston, MA 02115, USA. 4. Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, MD 21205, USA. 5. Division of General Internal Medicine, Johns Hopkins University School of Medicine, MD 21287, USA. 6. Department of Medicine, University of Massachusetts Medical School, Worcester, MA 01655, USA.
Abstract
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.
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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