Patient-relevant outcomes associated with generic tamsulosin, levothyroxine and amphetamine in the FDA Adverse Event Reporting System: A pilot study

Sathiya Priya Marimuthu, Geetha Iyer, Jodi B. Segal, Sonal Singh

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)437-447
Number of pages11
JournalJournal of Comparative Effectiveness Research
Volume6
Issue number5
DOIs
StatePublished - Jul 1 2017

Keywords

  • amphetamine
  • FAERS database
  • levothyroxine
  • patient-relevant outcomes
  • PROMIS outcome
  • tamsulosin

ASJC Scopus subject areas

  • Health Policy

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