ArticleJournal of pain research2025
Evaluating Triptan Safety in Pediatric Migraine Management: A Comprehensive Pharmacovigilance Analysis.
Article in Journal of pain research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Introduction: Triptans are the only FDA-approved migraine-specific treatment for pediatric patients, yet comprehensive real-world safety data remains limited, particularly regarding rare adverse events and age-specific safety profiles. Methods and Materials: We conducted a pharmacovigilance analysis using the FDA Adverse Event Reporting System (FAERS) database from 2004-2024, focusing on adverse events associated with sumatriptan, rizatriptan, zolmitriptan, and almotriptan in patients aged 6-18 years. After systematic deduplication following FDA guidelines, disproportionality analysis was performed using reporting odds ratios (ROR) and risk-signal detection ratios (RSDR). Subgroup analyses compared safety signals between children (6-11 years) and adolescents (12-18 years) at both Preferred Terms and System Organ Class levels. Results: Among 19,557 triptan-related cases in FAERS, 375 (1.9%) were pediatric cases, predominantly female (70.7%) and aged 12-18 years (91.2%). Sumatriptan was most frequently reported (77.3%), followed by rizatriptan (17.9%). Significant safety signals included posterior reversible encephalopathy syndrome with sumatriptan (ROR=86.69, 95% CI=26.6-282.54), acute respiratory failure with rizatriptan (ROR=98.12, 95% CI=40.17-239.64), and renal infarction with zolmitriptan (ROR=2231.93, 95% CI=667.65-7461.24). Age-stratified analysis revealed distinct profiles: younger children (6-11 years) showed higher risks for gastric emptying impairment (ROR=331.24) and throat tightness (ROR=77.14), while adolescents (12-18 years) experienced more diverse adverse events, notably pharyngeal swelling (ROR=133.81) and chest discomfort (ROR=19.05). Conclusion: Real-world triptan safety profiles reveal age-specific risks in pediatric populations, emphasizing the need for tailored monitoring strategies and age-appropriate safety protocols.
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