Pregabalin Use in Individuals Under 18 Years of Age
Pregabalin should not be used in patients under 18 years of age except for adjunctive therapy for partial onset seizures in patients 17 years of age and older, as this is the only FDA-approved pediatric indication. 1
FDA-Approved Indications for Pregabalin
- Pregabalin is FDA-approved for adjunctive therapy for partial onset seizures in patients 17 years of age and older 1
- For adults (18 years and older), pregabalin is approved for:
Evidence for Pediatric Use
- A randomized controlled trial demonstrated efficacy of pregabalin 10 mg/kg/day in children aged 4-16 years with focal onset seizures, showing a 19.9% improvement over placebo (p=0.0185) 2
- Common adverse events in this pediatric study included somnolence (25.8% with 10 mg/kg/day vs. 13.8% with placebo), increased weight (13.4% vs. 4.3%), and increased appetite (10.3% vs. 4.3%) 2
- A small prospective open-label study in 19 children (ages 4-15 years) with severe drug-resistant epilepsy showed that 37% had >50% seizure reduction with pregabalin 150-300 mg/day 3
- However, in this study, pregabalin was withdrawn in 11% of children due to worsening of myoclonic epilepsy, suggesting caution in this specific epilepsy type 3
Safety Considerations in Pediatric Patients
- The FDA label does not include specific pediatric dosing information for indications other than partial onset seizures in patients 17 years of age and older 1
- Side effects reported in pediatric studies include somnolence, weight gain, dizziness, and behavioral changes 3
- Pregabalin should be used with caution in patients with myoclonic epilepsy as it may worsen this condition 3
Risk of Abuse Potential
- There is growing concern about pregabalin's abuse potential, with approximately 9.6% of users receiving doses exceeding the recommended maximum of 600 mg/day 4
- Risk factors for high-dose use include male gender and concomitant use of antipsychotics and benzodiazepines 4
- This abuse potential is an additional concern when considering use in adolescents 4
Conclusion
While there is some evidence supporting pregabalin's efficacy in pediatric epilepsy, the FDA has only approved its use for partial onset seizures in patients 17 years and older. For all other indications, pregabalin is not approved for use in patients under 18 years of age. Clinicians should adhere to these regulatory guidelines and consider alternative treatments with established safety and efficacy in pediatric populations.