Phenylpropanolamine Should Not Be Used in Infants
Phenylpropanolamine is contraindicated in infants under 12 months of age and should not be prescribed for this population. This medication has been withdrawn from the U.S. market due to serious safety concerns, including hemorrhagic stroke risk, and lacks any established pediatric dosing guidelines for infants 1.
Critical Safety Concerns
Market Withdrawal and Stroke Risk
- Phenylpropanolamine was associated with a significantly increased risk of hemorrhagic stroke, particularly in women using appetite suppressants (adjusted odds ratio 16.58) and with first-time use of products containing this agent 1
- The medication caused transient hypertension even at recommended adult doses, with 150 mg producing clinically significant blood pressure elevations into the hypertensive range 2
- Case reports documented cerebral infarction occurring after even a single oral dose in young adults 3
Absence of Pediatric Data
- No established therapeutic indication or dosing guidelines exist for phenylpropanolamine in the pediatric population 4
- The medication was never approved for use in infants, and the absence of pediatric dosage forms increases the potential for serious—sometimes fatal—complications in young patients 4
Clinical Pitfalls to Avoid
Common Misconceptions
- Do not attempt to calculate a weight-based dose from adult recommendations, as infants have unique pharmacokinetic parameters that differ substantially from adults and require individualized consideration of age, size, and organ maturity 4
- Do not assume over-the-counter availability indicates safety in younger populations, as phenylpropanolamine's widespread availability without prescription contributed to its misuse and serious adverse events 2, 5
Safer Alternatives
- For nasal congestion in infants, consider saline nasal drops and bulb suctioning as first-line non-pharmacologic interventions
- If pharmacologic treatment is necessary for respiratory symptoms, consult current pediatric guidelines for age-appropriate alternatives that have established safety profiles in infants
Regulatory Status
- The FDA advisory review panel classified phenylpropanolamine as generally safe and effective only for short-term weight control in adults (maximum 75 mg daily), not for pediatric use 5
- The medication has since been removed from the U.S. market entirely due to the hemorrhagic stroke risk identified in the case-control study of 702 patients 1