Chen Junchen, Huang Shunqiu, Chen Yashi, Luo Cheng, Li Yong
Department of Neurosurgery, the First Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong, People's Republic of China.
J Pain Res. 2025 Jun 27;18:3185-3205. doi: 10.2147/JPR.S524809. eCollection 2025.
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.
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.
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).
Real-world triptan safety profiles reveal age-specific risks in pediatric populations, emphasizing the need for tailored monitoring strategies and age-appropriate safety protocols.
曲坦类药物是美国食品药品监督管理局（FDA）批准的唯一用于儿科患者的偏头痛特异性治疗药物，但全面的真实世界安全性数据仍然有限，尤其是关于罕见不良事件和特定年龄的安全性概况。
我们使用2004年至2024年的FDA不良事件报告系统（FAERS）数据库进行了药物警戒分析，重点关注6至18岁患者中与舒马曲坦、利扎曲坦、佐米曲坦和阿莫曲坦相关的不良事件。按照FDA指南进行系统的重复数据删除后，使用报告比值比（ROR）和风险信号检测率（RSDR）进行不成比例分析。亚组分析在首选术语和系统器官分类水平上比较了儿童（6至11岁）和青少年（12至18岁）之间的安全信号。
在FAERS中19557例与曲坦类药物相关的病例中，375例（1.9%）为儿科病例，主要为女性（70.7%），年龄在12至18岁之间（91.2%）。舒马曲坦报告频率最高（77.3%），其次是利扎曲坦（17.9%）。显著的安全信号包括舒马曲坦导致的后部可逆性脑病综合征（ROR=86.69，95%CI=26.6-282.54）、利扎曲坦导致的急性呼吸衰竭（ROR=98.12，95%CI=40.17-239.64）以及佐米曲坦导致的肾梗死（ROR=2231.93，95%CI=667.65-7461.24）。年龄分层分析显示出不同的概况：年幼儿童（6至11岁）出现胃排空障碍（ROR=331.24）和喉咙发紧（ROR=77.14）的风险较高，而青少年（12至18岁）经历的不良事件更多样化，尤其是咽部肿胀（ROR=133.81）和胸部不适（ROR=19.05）。
真实世界中曲坦类药物的安全性概况揭示了儿科人群中特定年龄的风险，强调了制定针对性监测策略和适合年龄的安全方案的必要性。
