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Systematic analysis of safety profile for darunavir and its boosted agents using data mining in the FDA Adverse Event Reporting System database
- Source :
- Scientific Reports, Vol 11, Iss 1, Pp 1-9 (2021), Scientific Reports
- Publication Year :
- 2021
- Publisher :
- Springer Science and Business Media LLC, 2021.
-
Abstract
- This current investigation was aimed to generate signals for adverse events (AEs) of darunavir-containing agents by data mining using the US Food and Drug Administration Adverse Event Reporting System (FAERS). All AE reports for darunavir, darunavir/ritonavir, or darunavir/cobicistat between July 2006 and December 2019 were identified. The reporting Odds Ratio (ROR), proportional reporting ratio (PRR), and Bayesian confidence propagation neural network (BCPNN) were used to detect the risk signals. A suspicious signal was generated only if the results of the three algorithms were all positive. A total of 10,756 reports were identified commonly observed in hepatobiliary, endocrine, cardiovascular, musculoskeletal, gastrointestinal, metabolic, and nutrition system. 40 suspicious signals were generated, and therein 20 signals were not included in the label. Severe high signals (i.e. progressive extraocular muscle paralysis, acute pancreatitis, exfoliative dermatitis, acquired lipodystrophy and mitochondrial toxicity) were identified. In pregnant women, umbilical cord abnormality, fetal growth restriction, low birth weight, stillbirth, premature rupture of membranes, premature birth and spontaneous abortion showed positive signals. Darunavir and its boosted agents induced AEs in various organs/tissues, and were shown to be possibly associated with multiple adverse pregnant conditions. This study highlighted some novel and severe AEs of darunavir which need to be monitored prospectively.
- Subjects :
- Adult
Male
Adolescent
Drug-Related Side Effects and Adverse Reactions
Science
HIV Infections
computer.software_genre
Article
Pharmacovigilance
Young Adult
030207 dermatology & venereal diseases
03 medical and health sciences
Adverse Event Reporting System
Medical research
0302 clinical medicine
Pregnancy
medicine
Adverse Drug Reaction Reporting Systems
Data Mining
Humans
030212 general & internal medicine
Exfoliative dermatitis
Adverse effect
Darunavir
Multidisciplinary
United States Food and Drug Administration
business.industry
Cobicistat
Health care
HIV Protease Inhibitors
Odds ratio
Middle Aged
medicine.disease
United States
Pregnancy Complications
Medicine
Female
Ritonavir
Data mining
Lipodystrophy
business
computer
medicine.drug
Subjects
Details
- ISSN :
- 20452322
- Volume :
- 11
- Database :
- OpenAIRE
- Journal :
- Scientific Reports
- Accession number :
- edsair.doi.dedup.....b2c0528e768e3421fac3c5c9abddf4da