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Post-marketing safety concerns with montelukast: A pharmacovigilance study based on the FDA adverse event reporting
Abstract:
The United States Food and Drug Administration (FDA) has been warning about the psychiatric disorders associated with montelukast (MTK) for years. To study the characteristics of the presence of MTK-associated adverse events (AEs), we obtained data from the FDA Adverse Event Reporting System database and used a case (MTK) vs. non-case (all other drugs) analysis to investigate the safety signals in a disproportionality study. 27,507 reported AEs from January 2004 to December 2022 were analyzed. Disproportionality analysis shows that psychiatric, respiratory, thoracic, and mediastinal disorders as well as social circumstances are the most commonly reported AEs. In addition, our study found several unreported AEs, such as increased systolic blood pressure, diastolic dysfunction, hypothyroidism, obesity, bursitis, and polycystic ovaries. The timing of AE occurrence indicates that MTK-associated AEs are mainly acute effects. Most importantly, we found that 60.1% of patients reporting AEs in the category of psychiatric disorders were younger than 18 years. In summary, we revealed an age-preference pattern of psychiatric AEs in patients prescribed MTK. Our study is helpful for physicians and health professionals to better evaluate the value and risk of MTK and to achieve the goal of optimal patient care.
Insights
Montelukast (MTK) is linked to psychiatric disorders, especially in patients under 18. This study analyzed FDA data, revealing psychiatric and other adverse events associated with MTK, highlighting an age-preference pattern for psychiatric side effects.
Area of Science:
- Pharmacovigilance and Drug Safety
- Clinical Pharmacology
- Adverse Event Analysis
Background:
- The U.S. Food and Drug Administration (FDA) has issued warnings regarding psychiatric disorders linked to montelukast (MTK).
- Understanding the characteristics of MTK-associated adverse events (AEs) is crucial for patient safety and risk-benefit assessment.
Purpose of the Study:
- To investigate the safety signals of montelukast (MTK) by analyzing its associated adverse events (AEs).
- To characterize the types and patterns of AEs reported for MTK using disproportionality analysis.
- To identify potential unreported AEs and age-specific trends in MTK-associated psychiatric disorders.
Main Methods:
- Utilized the FDA Adverse Event Reporting System (FAERS) database for data extraction.
- Conducted a case (MTK) vs. non-case (all other drugs) disproportionality analysis on 27,507 reported AEs from January 2004 to December 2022.
- Analyzed the timing of AE occurrence and demographic data, focusing on psychiatric AEs in pediatric populations.
Main Results:
- Psychiatric, respiratory, thoracic, and mediastinal disorders, along with social circumstances, were the most frequently reported AEs associated with MTK.
- Identified several potentially unreported AEs, including increased systolic blood pressure, diastolic dysfunction, hypothyroidism, obesity, bursitis, and polycystic ovaries.
- MTK-associated AEs predominantly manifest as acute effects, with 60.1% of psychiatric AE reports involving patients younger than 18 years.
Conclusions:
- Montelukast (MTK) is associated with a range of adverse events, notably psychiatric disorders, with a significant predilection in pediatric patients.
- The findings reveal an age-preference pattern for psychiatric AEs in patients prescribed MTK, emphasizing the need for careful monitoring in younger individuals.
- This study provides valuable insights for healthcare professionals to optimize patient care by better evaluating the risks and benefits of MTK.
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