Identification of Novel Signals Associated with US-FDA Approved Drugs (2013) Using Disproportionality Analysis.
Disproportionality analysis
FAERS
OpenVigil 2.1
Sensitivity analysis
Signal detection
US-FDA approved drugs
Journal
Current drug safety
ISSN: 2212-3911
Titre abrégé: Curr Drug Saf
Pays: United Arab Emirates
ID NLM: 101270895
Informations de publication
Date de publication:
21 Nov 2023
21 Nov 2023
Historique:
received:
17
08
2023
revised:
19
09
2023
accepted:
22
09
2023
medline:
22
11
2023
pubmed:
22
11
2023
entrez:
22
11
2023
Statut:
aheadofprint
Résumé
Drugs are related with various adverse drug reactions (ADRs), however, many unexpected ADRs of drugs are reported through post-marketing surveillance. The current study's goal is to uncover potential signals connected with FDA-approved medications in the United States (2013). Open Vigil 2.1-MedDRA-v24 (data 20004Q1-2021Q3) was used as a tool to query the FAERS data. To find possible signals, disproportionality measures such as Proportional Reporting Ratio (PRR 2) with associated Chi-square value, Reporting Odds Ratio (ROR 2) with 95% confidence interval, and case count (3) were calculated. A total of eight potential signals were identified with five drugs. Positive signals were found with pomalidomide, canagliflozin, dolutegravir sodium, macitentan and ibrutinib. However, further causality assessment is required to confirm the association of these drugs with identified potential signals.
Sections du résumé
BACKGROUND
BACKGROUND
Drugs are related with various adverse drug reactions (ADRs), however, many unexpected ADRs of drugs are reported through post-marketing surveillance.
AIM
OBJECTIVE
The current study's goal is to uncover potential signals connected with FDA-approved medications in the United States (2013).
METHODOLOGY
METHODS
Open Vigil 2.1-MedDRA-v24 (data 20004Q1-2021Q3) was used as a tool to query the FAERS data. To find possible signals, disproportionality measures such as Proportional Reporting Ratio (PRR 2) with associated Chi-square value, Reporting Odds Ratio (ROR 2) with 95% confidence interval, and case count (3) were calculated.
RESULTS
RESULTS
A total of eight potential signals were identified with five drugs. Positive signals were found with pomalidomide, canagliflozin, dolutegravir sodium, macitentan and ibrutinib.
CONCLUSION
CONCLUSIONS
However, further causality assessment is required to confirm the association of these drugs with identified potential signals.
Identifiants
pubmed: 37990902
pii: CDS-EPUB-136197
doi: 10.2174/0115748863276447231108092936
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.