Ubrelvy (Ubrogepant) is NOT Approved for Use in a 14-Year-Old Female
Ubrelvy should not be prescribed to this patient, as it is only FDA-approved for adults aged 18 years and older for the acute treatment of migraine with or without aura. 1, 2
FDA Approval and Age Restrictions
- Ubrogepant received FDA approval in December 2019 specifically for adults, with clinical trials enrolling participants aged 18-75 years 3, 1, 4
- The pivotal ACHIEVE I and ACHIEVE II trials that established ubrogepant's efficacy and safety explicitly enrolled only adults, with no pediatric data available 3, 5
- There are no published studies, safety data, or pharmacokinetic information for ubrogepant use in patients under 18 years of age 3, 1
Why This Matters for a 14-Year-Old
- Lack of safety data: Without pediatric trials, we cannot determine if ubrogepant's safety profile in adolescents matches that seen in adults, where the most common adverse events included nausea (2.1-4.1%), somnolence, and dry mouth 3
- Unknown efficacy: The drug's mechanism as a CGRP receptor antagonist has not been studied in developing adolescent physiology 2
- Regulatory precedent: Historical FDA guidance emphasizes that pediatric populations require specific safety and pharmacokinetic data, not just extrapolation from adult studies, particularly for novel drug classes 6
Alternative Migraine Treatment Considerations
For adolescent migraine patients, clinicians should consider FDA-approved acute migraine treatments that have established pediatric safety profiles. The regulatory framework for pediatric drug approval has evolved significantly, requiring specific pediatric studies rather than simple extrapolation from adult data 6.
Common Pitfall to Avoid
Do not assume that adult migraine medications are automatically safe for adolescents simply because migraine pathophysiology appears similar across age groups. The FDA's pediatric regulations exist precisely because drug metabolism, safety profiles, and efficacy can differ significantly in younger populations 6.