Metoprolol adverse events and literature analyses: case/non-case analyses using the FDA Adverse Event Reporting
Yikuan Du1,2, Mengting Zhang3, Ziyi Luo3
1Central Laboratory, The Tenth Affiliated Hospital of Southern Medical University, Dongguan, China.
Background:
In recent years, β-blockers such as metoprolol have been upgraded to first-line antihypertensive drugs. However, metoprolol demonstrates poor prognosis effects on diseases such as stroke. Further clinical application may expand the possibility of its related adverse reactions. Currently, there is a lack of comprehensive research on the overall safety of metoprolol.
Research Design And Methods:
Statistical analysis and signal mining were conducted on adverse event reports related to metoprolol obtained from the FAERS database. Signal mining was conducted using the proportional reporting ratio, the report margin method, the bayesian confidence propagation neural network, and empirical Bayesian geometric mean in the measures of disproportionality to detect potential adverse reaction signals.
Results:
The results showed 16,853 reports related to metoprolol use, identifying 506 preferred terms (PTs) covering 23 system organ classes (SOCs). In addition, some new potential adverse reactions appeared among the top 30 PTs ranked by signal strength, such as 'orthostatic intolerance' (IC025 = 3.00), 'trigemino-cardiac reflex' (IC025 = 4.30), 'decorticate posture' (IC025 = 3.34), etc. Notably, there was a strong association between 'suspected suicide' (IC025 = 5.59) and the drug signal.
Conclusions:
This study identified unexpected signals of serious adverse reactions, suggesting the importance of continuous post-marketing surveillance of metoprolol to understand its potential risks.
Insights
Metoprolol, a common hypertension drug, shows potential safety concerns including rare adverse reactions like trigemino-cardiac reflex and suspected suicide. Continuous monitoring is crucial for understanding metoprolol
Area of Science:
- Pharmacovigilance and Drug Safety
- Cardiovascular Pharmacology
- Clinical Pharmacy
Background:
- Metoprolol is a widely used beta-blocker for hypertension, often prescribed as a first-line treatment.
- Despite its efficacy, concerns exist regarding metoprolol's potential adverse effects, particularly in conditions like stroke.
- Comprehensive research on the overall safety profile and potential adverse reactions of metoprolol is currently limited.
Purpose of the Study:
- To conduct a comprehensive safety analysis of metoprolol using adverse event reporting data.
- To identify potential new or under-reported adverse reactions associated with metoprolol use.
- To assess the overall risk-benefit profile of metoprolol through signal detection methodologies.
Main Methods:
- Utilized the FAERS database to extract adverse event reports associated with metoprolol.
- Employed multiple statistical signal-mining algorithms, including PRR, RRM, BCNN, and EBGM, to detect disproportionality.
- Analyzed 16,853 reports, identifying 506 preferred terms across 23 system organ classes.
Main Results:
- Identified 506 preferred terms (PTs) related to metoprolol, categorized into 23 system organ classes (SOCs).
- Detected novel potential adverse reactions such as 'orthostatic intolerance', 'trigemino-cardiac reflex', and 'decorticate posture'.
- Revealed a significant association between metoprolol and 'suspected suicide' (IC025 = 5.59), indicating a strong safety signal.
Conclusions:
- The study highlights unexpected serious adverse reaction signals associated with metoprolol.
- Findings underscore the necessity for ongoing post-marketing surveillance of metoprolol.
- Continuous monitoring is essential to fully elucidate and manage the potential risks of metoprolol.
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