Phenylpropanolamine is Not Recommended for Use in Children
Phenylpropanolamine (PPA) should not be used in pediatric patients due to significant safety concerns, including risk of hemorrhagic stroke, hypertensive crisis, and psychiatric adverse effects, particularly in children under 6 years of age who are at heightened risk. 1, 2, 3
Critical Safety Concerns
Severe Adverse Events in Pediatric Population
Children under 6 years are identified as a particularly high-risk group for PPA-related adverse reactions, including psychiatric side effects such as acute mania, paranoid symptoms, and organic psychosis 1
Serious cardiovascular events have been documented, including 24 intracranial hemorrhages, 8 seizures, and 8 deaths (mostly from stroke) associated with PPA ingestion across all age groups 2
82% of adverse drug reactions occurring at non-overdose amounts were classified as severe, with acute hypertension and severe headache being the most common presentations 2
Regulatory Status and Market Withdrawal
PPA was widely available in over 130 medications in the United States, primarily as decongestants and appetite suppressants, but the association between PPA use and hemorrhagic stroke led to its removal from the U.S. market 4, 3
The FDA advisory panel's classification of PPA as "generally safe and effective" applied only to short-term weight control in adults (maximum 75 mg daily, not exceeding 12 weeks), not pediatric use 4
Why No Pediatric Dosing Exists
Lack of Established Pediatric Guidelines
None of the reviewed pediatric emergency medicine guidelines from the American Academy of Pediatrics mention PPA dosing, despite comprehensive coverage of other sympathomimetic agents 5
The absence of PPA from authoritative pediatric drug references reflects the unacceptable risk-benefit profile in children 5
Disproportionate Risk in Vulnerable Populations
More adverse reactions occurred after ingestion of recommended doses than overdoses in reported cases, suggesting unpredictable individual susceptibility 1
The combination of PPA with other ingredients (common in over-the-counter products) or concurrent medications significantly increased the risk of severe adverse events 2
Clinical Implications
Alternative Agents Available
For nasal congestion in children, safer alternatives include oxymetazoline (topical) or pseudoephedrine with established pediatric dosing and better safety profiles
For any indication previously considered for PPA, modern evidence-based alternatives exist with superior safety data in pediatric populations
Recognition of PPA-Related Toxicity
If a child presents with acute hypertension, severe headache, altered mental status, or psychiatric symptoms of unclear etiology, inquire about possible PPA exposure from imported products or older medications 2
Failure to recognize PPA as an etiological agent historically led to misdiagnosis (schizophrenia or mania), lengthy hospitalization, and inappropriate treatment with neuroleptics or lithium 1