Expert opinion on drug safety · 2024
Pharmacologically induced autoimmune encephalitis-disproportionality analysis utilizing FAERS database.
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Hu Kaikai, Jin Liuyin, Zhou Yixia, Xie Guoming
Аннотация
BACKGROUND: Autoimmune encephalitis (AE) is a neuroimmune disorder that presents significant diagnostic challenges. The FDA Adverse Event Reporting System (FAERS) database can help explore the relationship between drugs and AE, but comprehensive studies are lacking. This study aims to analyze the association between drugs and AE using the FAERS database, providing insights for clinical practice and pharmacovigilance.
RESEARCH DESIGN AND METHODS: Adverse event reports in the FAERS database were analyzed, focusing on the incidence of drug-induced AE, as well as characteristics such as gender and age. Multiple statistical methods were employed to assess the association between drugs and adverse reactions.
RESULTS: The study revealed that drug-induced AE predominantly occurred in individuals aged 41 and above, with a higher prevalence among female patients. Nivolumab and pembrolizumab were among the drugs most frequently reported for adverse drug reactions. However, only a minority of drug labels mentioned these adverse reactions.
CONCLUSION: This study underscores the potential risk of drug-induced AE, advocating for close monitoring in clinical practice. Further epidemiological investigations are warranted to elucidate the exact relationship between drugs and these disorders. While the FAERS database provides crucial leads for such research, additional studies and validation are necessary.
RESEARCH DESIGN AND METHODS: Adverse event reports in the FAERS database were analyzed, focusing on the incidence of drug-induced AE, as well as characteristics such as gender and age. Multiple statistical methods were employed to assess the association between drugs and adverse reactions.
RESULTS: The study revealed that drug-induced AE predominantly occurred in individuals aged 41 and above, with a higher prevalence among female patients. Nivolumab and pembrolizumab were among the drugs most frequently reported for adverse drug reactions. However, only a minority of drug labels mentioned these adverse reactions.
CONCLUSION: This study underscores the potential risk of drug-induced AE, advocating for close monitoring in clinical practice. Further epidemiological investigations are warranted to elucidate the exact relationship between drugs and these disorders. While the FAERS database provides crucial leads for such research, additional studies and validation are necessary.
Предметные рубрики MeSH
HumansFemaleDatabases, FactualAdverse Drug Reaction Reporting SystemsMaleMiddle AgedAdultEncephalitisUnited StatesAgedPharmacovigilanceYoung AdultSex FactorsAge FactorsUnited States Food and Drug AdministrationHashimoto DiseaseAdolescentDrug-Related Side Effects and Adverse ReactionsChildIncidenceAged, 80 and overDrug Labeling