PMID- 30354029
OWN - NLM
STAT- MEDLINE
DCOM- 20191104
LR  - 20200309
IS  - 2163-8306 (Electronic)
IS  - 2163-8306 (Linking)
VI  - 7
IP  - 12
DP  - 2018 Dec
TI  - Target-Adverse Event Profiles to Augment Pharmacovigilance: A Pilot Study With 
      Six New Molecular Entities.
PG  - 809-817
LID - 10.1002/psp4.12356 [doi]
AB  - Clinical trials can fail to detect rare adverse events (AEs). We assessed the 
      ability of pharmacological target adverse-event (TAE) profiles to predict AEs on 
      US Food and Drug Administration (FDA) drug labels at least 4 years after 
      approval. TAE profiles were generated by aggregating AEs from the FDA adverse 
      event reporting system (FAERS) reports and the FDA drug labels for drugs that hit 
      a common target. A genetic algorithm (GA) was used to choose the adverse event 
      (AE) case count (N), disproportionality score in FAERS (proportional reporting 
      ratio (PRR)), and percent of comparator drug labels with an AE to maximize 
      F-measure. With FAERS data alone, precision, recall, and specificity were 0.57, 
      0.78, and 0.61, respectively. After including FDA drug label data, precision, 
      recall, and specificity improved to 0.67, 0.81, and 0.71, respectively. Eighteen 
      of 23 (78%) postmarket label changes were identified correctly. TAE analysis 
      shows promise as a method to predict AEs at the time of drug approval.
CI  - (c) 2018 This article is a U.S. Government work and is in the public domain in the 
      USA. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, 
      Inc. on behalf of the American Society for Clinical Pharmacology and 
      Therapeutics.
FAU - Schotland, Peter
AU  - Schotland P
AD  - Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office 
      of Translational Science, Center for Drug Evaluation and Research, Food and Drug 
      Administration, Silver Spring, Maryland, USA.
FAU - Racz, Rebecca
AU  - Racz R
AD  - Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office 
      of Translational Science, Center for Drug Evaluation and Research, Food and Drug 
      Administration, Silver Spring, Maryland, USA.
FAU - Jackson, David
AU  - Jackson D
AD  - Molecular Health GmbH, Heidelberg, Germany.
FAU - Levin, Robert
AU  - Levin R
AD  - Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, 
      Food and Drug Administration, Silver Spring, Maryland, USA.
FAU - Strauss, David G
AU  - Strauss DG
AD  - Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office 
      of Translational Science, Center for Drug Evaluation and Research, Food and Drug 
      Administration, Silver Spring, Maryland, USA.
FAU - Burkhart, Keith
AU  - Burkhart K
AD  - Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office 
      of Translational Science, Center for Drug Evaluation and Research, Food and Drug 
      Administration, Silver Spring, Maryland, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, U.S. Gov't, P.H.S.
DEP - 20181024
PL  - United States
TA  - CPT Pharmacometrics Syst Pharmacol
JT  - CPT: pharmacometrics & systems pharmacology
JID - 101580011
SB  - IM
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Humans
MH  - *Pharmacovigilance
MH  - Pilot Projects
PMC - PMC6310867
EDAT- 2018/10/26 06:00
MHDA- 2019/11/05 06:00
PMCR- 2018/12/01
CRDT- 2018/10/25 06:00
PHST- 2018/06/11 00:00 [received]
PHST- 2018/09/06 00:00 [accepted]
PHST- 2018/10/26 06:00 [pubmed]
PHST- 2019/11/05 06:00 [medline]
PHST- 2018/10/25 06:00 [entrez]
PHST- 2018/12/01 00:00 [pmc-release]
AID - PSP412356 [pii]
AID - 10.1002/psp4.12356 [doi]
PST - ppublish
SO  - CPT Pharmacometrics Syst Pharmacol. 2018 Dec;7(12):809-817. doi: 
      10.1002/psp4.12356. Epub 2018 Oct 24.