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Neuropsychiatric adverse reactions of leukotriene receptor antagonist, antihistamine and inhaled corticosteroid: A real-world analysis of the Food and Drug Administration (FDA) Adverse Event Reporting
  • +6
  • Sainan Bian,
  • Lisha Li,
  • Zixi Wang,
  • Le Cui,
  • Ying-Yang Xu,
  • Kai Guan,
  • Bin Zhao,
  • Lianglu Wang,
  • Jia Yin
Sainan Bian
Peking Union Medical College Hospital
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Lisha Li
Peking Union Medical College Hospital
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Zixi Wang
Peking Union Medical College Hospital
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Le Cui
Peking Union Medical College Hospital
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Ying-Yang Xu
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
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Kai Guan
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Corresponding Author:[email protected]

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Bin Zhao
Peking Union Medical College Hospital
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Lianglu Wang
Peking Union Medical College Hospital
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Jia Yin
Peking Union Medical College Hospital
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Abstract

Background There are limited real-world studies about the differences of leukotriene receptor antagonist (LTRA), antihistamine and inhaled corticosteroid (ICS) associated neuropsychiatric events. We aimed in this study to summarize the clinical characteristics of drug associated neuropsychiatric events and compare the differences between different drug categories. Methods Disproportionality analysis and Bayesian analysis were used in data mining to screen the suspected neuropsychiatric events with LTRA, antihistamine and ICS based on the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from January 2004 to September 2020. Results A total of 9475 neuropsychiatric events were identified. Neuropsychiatric events related to LTRA, antihistamine and ICS were 5201 (54.89%), 3226 (34.05%), and 1048 (11.06%), respectively. LTRA related neuropsychiatric events were more common in patients aged from 4 to 6 years old (18.66%), while antihistamine and ICS related neuropsychiatric events were more common in patients with 18 to 44 years old (29.92%) and older than 65 years old (30.60%), respectively. Montelukast was considered to have the tightest relationship to neuropsychiatric events, followed by the first generation of antihistamine. Most neuropsychiatric symptoms occurred within the first 10 days after drug initiation. Death rate due to neuropsychiatric events of antihistamine was significantly higher than LTRA and ICS (p<0.001). Conclusions LTRA associated neuropsychiatric events was most frequent in 4 to 6-year old children and most cases occurred with the first 10 days after drug initiation. Fatality rate due to antihistamine associated neuropsychiatric events was higher than LTRA and ICS.