Evaluating Triptan Safety in Pediatric Migraine Management: A Comprehensive Pharmacovigilance Analysis.

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.