1. Patient-relevant outcomes associated with generic tamsulosin, levothyroxine and amphetamine in the FDA Adverse Event Reporting System: a pilot study.
- Author
-
Marimuthu SP, Iyer G, Segal JB, and Singh S
- Subjects
- Adult, Adverse Drug Reaction Reporting Systems, Aged, Aged, 80 and over, Female, Humans, Male, Medical Records, Middle Aged, Pilot Projects, Prospective Studies, Treatment Outcome, United States, United States Food and Drug Administration, Amphetamine adverse effects, Drugs, Generic adverse effects, Tamsulosin adverse effects, Thyroxine adverse effects
- 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.
- Published
- 2017
- Full Text
- View/download PDF