Is naltrexone (opioid receptor antagonist) suitable for a 15-year-old?

Naltrexone Use in 15-Year-Olds

Naltrexone should not be given to a 15-year-old, as the FDA label explicitly states that "the safe use of naltrexone hydrochloride in pediatric patients younger than 18 years old has not been established." 1

FDA-Approved Age Restrictions

• The FDA drug label clearly contraindicates naltrexone use in patients under 18 years of age due to lack of established safety data 1
• This represents a hard regulatory boundary that should not be crossed in routine clinical practice

Limited Exception for Opioid Use Disorder

While the general FDA approval excludes patients under 18, there is one narrow exception for severe opioid use disorder:

• The American Academy of Pediatrics (AAP) guidelines state that naltrexone is an FDA-approved medication for treating opioid use disorders in patients 16 years and older 2
• This creates a discrepancy where the general FDA label says under 18 is not established, but specific approval exists for opioid addiction treatment starting at age 16
• A 15-year-old falls below even this exception threshold and would not qualify 2

Clinical Evidence in Adolescents

The limited research available suggests potential but insufficient evidence:

• One small open-label pilot study (n=5) examined naltrexone in adolescent alcoholics and found it was well-tolerated with significant reductions in alcohol consumption 3
• However, this single small study is insufficient to override FDA restrictions, particularly for a 15-year-old 3
• The AAP specifically notes that naltrexone "may be a good therapeutic option for adolescents and young adults" but emphasizes this applies to those meeting age criteria for opioid use disorder treatment 2

Alternative Considerations

If treating opioid use disorder in a 15-year-old:

• Buprenorphine is FDA-approved for patients 16 years and older and has stronger evidence in adolescents with two randomized controlled trials supporting its efficacy 2
• For a 15-year-old with severe opioid use disorder, buprenorphine would be off-label but has more robust adolescent data than naltrexone 2
• Methadone is generally prohibited for patients under 18 by federal regulations 2

Critical Safety Considerations

The FDA label highlights important safety concerns that are particularly relevant when considering off-label pediatric use:

• Naltrexone can precipitate severe opioid withdrawal if the patient has not been opioid-free for an adequate period 1
• In emergency situations requiring opioid analgesia, patients on naltrexone may require higher opioid doses with deeper and more prolonged respiratory depression 1
• Hepatotoxicity concerns exist, though primarily at higher doses 1, 4

Bottom Line

Do not prescribe naltrexone to a 15-year-old. The patient is below the FDA-approved age threshold even for the specific indication of opioid use disorder (which requires age 16+). If treating substance use disorder, consider age-appropriate alternatives with established pediatric safety profiles.