PMID- 28686057
OWN - NLM
STAT- MEDLINE
DCOM- 20190607
LR  - 20220216
IS  - 2042-6313 (Electronic)
IS  - 2042-6305 (Print)
IS  - 2042-6305 (Linking)
VI  - 6
IP  - 5
DP  - 2017 Jul
TI  - Patient-relevant outcomes associated with generic tamsulosin, levothyroxine and 
      amphetamine in the FDA Adverse Event Reporting System: a pilot study.
PG  - 437-447
LID - 10.2217/cer-2017-0006 [doi]
AB  - 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.
FAU - Marimuthu, Sathiya Priya
AU  - Marimuthu SP
AD  - Center for Drug Safety & Effectiveness, Johns Hopkins Bloomberg School of Public 
      Health, MD 21205, USA.
AD  - Division of Clinical Pharmacology, Johns Hopkins School of Medicine, Baltimore, 
      MD 21287, USA.
FAU - Iyer, Geetha
AU  - Iyer G
AD  - Doctoral Student in Population Health Sciences, Harvard University, Boston, MA 
      02115, USA.
FAU - Segal, Jodi B
AU  - Segal JB
AD  - Center for Drug Safety & Effectiveness, Johns Hopkins Bloomberg School of Public 
      Health, MD 21205, USA.
AD  - Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, MD 
      21205, USA.
AD  - Division of General Internal Medicine, Johns Hopkins University School of 
      Medicine, MD 21287, USA.
FAU - Singh, Sonal
AU  - Singh S
AD  - Department of Medicine, University of Massachusetts Medical School, Worcester, MA 
      01655, USA.
LA  - eng
GR  - T32 GM066691/GM/NIGMS NIH HHS/United States
GR  - U01 FD005267/FD/FDA HHS/United States
PT  - Journal Article
DEP - 20170707
PL  - England
TA  - J Comp Eff Res
JT  - Journal of comparative effectiveness research
JID - 101577308
RN  - 0 (Drugs, Generic)
RN  - CK833KGX7E (Amphetamine)
RN  - G3P28OML5I (Tamsulosin)
RN  - Q51BO43MG4 (Thyroxine)
SB  - IM
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems
MH  - Aged
MH  - Aged, 80 and over
MH  - Amphetamine/*adverse effects
MH  - Drugs, Generic/*adverse effects
MH  - Female
MH  - Humans
MH  - Male
MH  - Medical Records
MH  - Middle Aged
MH  - Pilot Projects
MH  - Prospective Studies
MH  - Tamsulosin/*adverse effects
MH  - Thyroxine/*adverse effects
MH  - Treatment Outcome
MH  - United States
MH  - United States Food and Drug Administration
PMC - PMC8819589
OTO - NOTNLM
OT  - FAERS database
OT  - PROMIS outcome
OT  - amphetamine
OT  - levothyroxine
OT  - patient-relevant outcomes
OT  - tamsulosin
COIS- Financial & competing interests disclosure Funding for this study was made 
      possible by the FDA through grant U01FD005267. Views expressed in written 
      materials and by speakers do not necessarily reflect the official policies of the 
      Department of Health and Human Services, nor does any mention of trade names, 
      commercial practices, or organization imply endorsement by the US Government. The 
      authors have no other relevant affiliations or financial involvement with any 
      organization or entity with a financial interest in or financial conflict with 
      the subject matter or materials discussed in the manuscript apart from those 
      disclosed. No writing assistance was utilized in the production of this 
      manuscript.
EDAT- 2017/07/08 06:00
MHDA- 2019/06/08 06:00
PMCR- 2018/07/01
CRDT- 2017/07/08 06:00
PHST- 2017/07/08 06:00 [pubmed]
PHST- 2019/06/08 06:00 [medline]
PHST- 2017/07/08 06:00 [entrez]
PHST- 2018/07/01 00:00 [pmc-release]
AID - 10.2217/cer-2017-0006 [doi]
PST - ppublish
SO  - J Comp Eff Res. 2017 Jul;6(5):437-447. doi: 10.2217/cer-2017-0006. Epub 2017 Jul 
      7.