AI Article Synopsis

  • The study investigates the safety of various medications for narcolepsy, a lifelong neurological disorder, using five years of data from the FDA Adverse Event Reporting System (FAERS) to analyze pharmacological treatments like pitolisant, sodium oxybate, solriamfetol, and modafinil.
  • Data analysis revealed significant signals for adverse drug events (ADEs), especially psychiatric and nervous system-related issues, with sodium oxybate raising concerns about suicidal thoughts and respiratory problems, while other medications highlighted issues like drug inefficacy and pregnancy-related risks.
  • Overall, findings suggest that adverse reactions align with existing product warnings, emphasizing the need for careful management and monitoring of narcolepsy treatments.

Article Abstract

Objective: Narcolepsy, a rare neurological disorder believed to have an autoimmune etiology, necessitates lifelong management. This study aimed to provide evidence supporting the safety of pharmacological treatment for narcolepsy.

Methods: Five-year data on pitolisant, sodium oxybate, solriamfetol, and modafinil were extracted from the FDA Adverse Event Reporting System (FAERS) self-reporting database for the period spanning from 2019 to 2023. Various statistical methods, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network analysis (BCPNN), and multi-item gamma Poisson shrinker (MGPS), were employed to quantify the signals. Finally, a comparative analysis was conducted between demographic data, outcomes, and inherent associations among the medications and the signals.

Results: After data analysis, we obtained 50 signals (a cumulative count of 762 cases) for pitolisant, 640 signals (corresponding to 46,962 cases) for sodium oxybate, 40 signals (equivalent to 1,228 cases) for solriamfetol, and finally, 72 signals (representing 632 cases) for modafinil. The majority of these patients were female. Psychiatric and nervous system disorders were identified as the predominant adverse drug events (ADEs). For sodium oxybate, it is crucial to consider psychiatric disorders (such as suicidal ideation), respiratory disorders (including sleep apnea syndrome and respiratory depression), and signs of pregnancy and congenital familial diseases. For solriamfetol, noteworthy new ADEs include drug inefficacy, suicidal ideation, restless legs syndrome, and somnambulism. Furthermore, a relationship has been observed between modafinil use and restricted fetal growth, spontaneous abortion, cognitive disorders, and drug inefficacy and abuse.

Conclusion: The majority of observed adverse reactions in this study were consistent with those listed in the product instructions. However, potential novel or notable ADE signals were identified through real-world pharmacovigilance analysis. It is anticipated that this paper will offer additional information regarding safe and rational medication for narcolepsy.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11586220PMC
http://dx.doi.org/10.3389/fphar.2024.1415918DOI Listing

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