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A Pharmacovigilance Study from 2004 to 2024 Utilizing the FDA Adverse Event Reporting System (FAERS) Examines
Nuo Xu1, Xiaowen Lu2
1Department of Clinical Nutrition, The First Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong, People's Republic of China.
Background:
Triptans are commonly employed for acute migraine relief, yet concerns remain regarding their potential association with ischemic adverse events (IAEs). This study aimed to evaluate the association between triptan use and IAEs using real-world data from the FDA Adverse Event Reporting System (FAERS).
Methods:
We performed a retrospective pharmacovigilance analysis utilizing FAERS data spanning from Q1 2004 to Q3 2024. Reports of IAEs (stroke, including myocardial infarction, and other ischemic events) in patients using triptans were analyzed. The signal strength of triptan-associated IAEs was evaluated using disproportionality analysis with the reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN).
Results:
Analysis of the FAERS database (2004-2024) identified 1305 ischemic adverse events (AEs) linked to triptans, accounting for 6.60% of all triptan-related AEs. The report proportion varied among triptans, with naratriptan (12.23%) and almotriptan (12.15%) showing the highest rates, while sumatriptan (4.74%) had the lowest. Females comprised 69.4% of cases, and 20.4% of reports involved life-threatening outcomes or death. Disproportionality analysis revealed significant signals for almotriptan (ROR=3.34), naratriptan (ROR=2.96), and rizatriptan (ROR=2.41), with almotriptan exhibiting the strongest association. The most frequent ischemic AEs included arteriospasm coronary (ROR=33.59), reversible cerebral vasoconstriction syndrome (ROR=63.92), and coronary artery dissection (ROR=93.17). Mortality rates exceeded 6% for ischemic stroke and acute myocardial infarction. Time-to-onset analysis showed frovatriptan had the earliest median onset (3.5 days), while almotriptan had the longest (284 days). Serious AEs were more frequently reported for cerebral vasoconstriction, cerebral ischemia, and coronary artery disease (p<0.05). These findings suggest notable ischemic safety signals associated with triptans, particularly specific drug subtypes.
Conclusion:
This pharmacovigilance study suggests a potential association between triptan use and ischemic adverse events, particularly in high-risk patients. Clinicians should carefully evaluate cardiovascular risk factors before prescribing triptans and consider alternative treatments for susceptible individuals. Additional prospective studies are required to validate these findings.
Insights
Triptan medications for migraines may increase the risk of ischemic adverse events (IAEs), such as stroke. Specific triptans like almotriptan showed stronger associations, highlighting the need for careful patient risk assessment.
Area of Science:
- Pharmacovigilance and Drug Safety
- Cardiovascular Risk Assessment
- Neurology and Headache Management
Background:
- Triptans are widely used for acute migraine treatment.
- Concerns exist regarding the potential for triptans to cause ischemic adverse events (IAEs).
- Real-world data is crucial for evaluating drug safety profiles.
Purpose of the Study:
- To investigate the association between triptan use and IAEs.
- To analyze real-world data from the FDA Adverse Event Reporting System (FAERS).
- To identify specific triptans with higher risks of IAEs.
Main Methods:
- Retrospective pharmacovigilance analysis of FAERS data (Q1 2004 - Q3 2024).
- Analysis of reported IAEs (stroke, myocardial infarction, other ischemic events) associated with triptan use.
- Disproportionality analysis using reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN) to assess signal strength.
Main Results:
- 1305 IAEs were linked to triptans, representing 6.60% of triptan-related adverse events.
- Naratriptan (12.23%) and almotriptan (12.15%) had the highest IAE reporting rates; sumatriptan had the lowest (4.74%).
- Significant disproportionality signals for IAEs were found for almotriptan (ROR=3.34), naratriptan (ROR=2.96), and rizatriptan (ROR=2.41), with almotriptan showing the strongest association. Specific events like coronary arteriospasm, reversible cerebral vasoconstriction syndrome, and coronary artery dissection showed very high RORs. Mortality rates exceeded 6% for ischemic stroke and myocardial infarction.
Conclusions:
- Triptan use is associated with potential ischemic safety signals, particularly certain subtypes.
- Clinicians should assess cardiovascular risk factors before prescribing triptans.
- Further prospective studies are needed to confirm these findings and guide clinical practice.
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