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

J Comp Eff Res. 2017 Jul;6(5):437-447. doi: 10.2217/cer-2017-0006. Epub 2017 Jul 7.

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.

Keywords: FAERS database; PROMIS outcome; amphetamine; levothyroxine; patient-relevant outcomes; tamsulosin.

MeSH terms

  • Adult
  • Adverse Drug Reaction Reporting Systems
  • Aged
  • Aged, 80 and over
  • Amphetamine / adverse effects*
  • Drugs, Generic / adverse effects*
  • Female
  • Humans
  • Male
  • Medical Records
  • Middle Aged
  • Pilot Projects
  • Prospective Studies
  • Tamsulosin / adverse effects*
  • Thyroxine / adverse effects*
  • Treatment Outcome
  • United States
  • United States Food and Drug Administration

Substances

  • Drugs, Generic
  • Amphetamine
  • Tamsulosin
  • Thyroxine