Is Bromfed (brompheniramine and pseudoephedrine) safe to use during breastfeeding?

Bromfed During Breastfeeding

Bromfed (brompheniramine and pseudoephedrine combination) is contraindicated during breastfeeding according to FDA labeling, primarily due to the antihistamine component's higher risk of intolerance in small infants, particularly newborns. 1

FDA Contraindication

• The FDA drug label explicitly states: "Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Bromfed DM Cough Syrup is contraindicated in nursing mothers." 1
• This represents the strongest regulatory guidance available and should take precedence in clinical decision-making. 1

Component-Specific Considerations

Pseudoephedrine (Sympathomimetic Component)

• Acute, short-term use of pseudoephedrine may be considered with extreme caution, though phenylephrine is strongly preferred due to its poor oral bioavailability (38%), making it unlikely to produce clinical effects in breastfed infants. 2
• Critical concern: Pseudoephedrine's vasoconstrictive properties may significantly reduce milk supply, requiring close monitoring for decreased milk production. 2
• The Association of Anaesthetists notes that ephedrine (a related sympathomimetic) is "not likely to harm a breastfeeding infant" when used acutely, but this does not extend to chronic use. 3

Brompheniramine (Antihistamine Component)

• Antihistamines carry specific risks in breastfed infants including sedation, decreased alertness, and poor feeding. 1
• Small infants, newborns, and premature infants have particularly high intolerance to antihistamines. 1
• The elderly and infants are more susceptible to antihistamine adverse effects including dizziness and sedation. 1

Clinical Algorithm for Decision-Making

If maternal symptoms require treatment:

1. First-line: Non-pharmacologic interventions - saline nasal irrigation, humidification, adequate hydration 2
2. Second-line: Safer alternatives - phenylephrine preferred over pseudoephedrine for decongestant needs 2
3. Avoid: Combination products containing antihistamines during breastfeeding 1

Important Caveats

• Drug interactions: Bromfed has significant interactions with MAO inhibitors (contraindicated), CNS depressants (additive sedation), and antihypertensive drugs (reduced efficacy). 1
• Maternal conditions requiring caution: The sympathomimetic component necessitates caution in mothers with diabetes, hypertension, heart disease, or thyroid disease. 1
• Infant age matters: Risk is highest in newborns and infants under 6 months, whose hepatic and renal function is immature. 1

Risk Communication Strategy

• Most commonly used drugs are relatively safe during breastfeeding, but antihistamines represent a specific exception in young infants. 4
• The benefits of breastfeeding must be weighed against untreated maternal symptoms, but safer alternatives exist for this indication. 5
• Mothers should be counseled that discontinuation of breastfeeding is sometimes wrongly recommended, but in this specific case, the FDA contraindication is based on legitimate infant safety concerns. 1, 5