1.2. Pediatrics

Rizatriptan is the only SRA FDA approved in children 6 to 17 years of age to treat acute migraine attacks in patients with a history of migraine with or without aura^1,2,7. Almotriptan, zolmitriptan nasal spray, and sumatriptan/naproxen are FDA approved for patients 12 years of age and older^1-3,16,17. Children/adolescents 6 to 17 years of age prescribed propranolol weighing less than 40 kg should not receive rizatriptan concurrently.7 Maximum recommended pediatric doses for SRAs are summarized in Tables 3 and 4. Dosages exceeding these recommendations will be reviewed.

The remaining SRAs are not FDA-approved for use in patients less than 18 years of age as safety and efficacy have not been established in this patient population. Additionally, patients less than 18 years of age have demonstrated a significant placebo response following SRA use as well as an adverse event profile, including serious adverse events, comparable to that seen in adults^4,9,10,18.

No significant data are available evaluating SRA use in pediatric patients younger than 6 years of age. In limited randomized, controlled trials, sumatriptan nasal spray has demonstrated some efficacy in mitigating migraine attacks in adolescents; children as young as 6 years of age have achieved favorable responses with intranasal sumatriptan in a few small randomized and open-label studies.19-21 However, oral sumatriptan tablets used in children 8 to 16 years of age to treat acute migraine attacks were not significantly better than placebo.22 A few small studies with oral zolmitriptan have shown mixed outcomes.23,24 Although not FDA-approved, Table 5 summarizes SRA doses that have been utilized in the pediatric population. Due to lack of definitive efficacy, prescriptions for SRAs not FDA-approved for pediatric patients will be reviewed in patients 6 to 18 years of age.