Are neomycin-polymyxin (antibiotic)/hydrocortisone (corticosteroid) ear drops safe to use in pregnant women?

Neomycin-Polymyxin/Hydrocortisone Ear Drops in Pregnancy

Neomycin-polymyxin/hydrocortisone ear drops can be used during pregnancy when clinically necessary, but should be used with caution due to the FDA Pregnancy Category C classification for the corticosteroid component and theoretical concerns about aminoglycoside ototoxicity, though systemic absorption from otic use is minimal.

Safety Profile and Risk Assessment

The FDA classifies this combination as Pregnancy Category C based on the hydrocortisone component 1. This means:

• Corticosteroids have demonstrated teratogenicity in animal studies when applied topically at high concentrations (0.5% in rabbits on days 6-18 of gestation, 15% in mice on days 10-13 of gestation) 1
• No adequate well-controlled studies exist in pregnant women for this specific otic formulation 1
• The product should be used only if potential benefits justify potential risks to the fetus 1

Systemic Absorption Considerations

The key factor making otic use relatively safer than systemic administration:

• Systemic absorption of hydrocortisone may occur when applied topically, but otic administration results in minimal systemic exposure compared to oral or parenteral routes 1
• Only 10% of maternal corticosteroid dose reaches the developing fetus with non-fluorinated steroids like hydrocortisone 2
• The small surface area of the ear canal and short treatment duration (typically 7-10 days maximum) further limit fetal exposure 1

Component-Specific Risks

Aminoglycosides (Neomycin)

• Aminoglycosides as a class carry theoretical ototoxicity concerns in pregnancy, though this is primarily documented with systemic use of streptomycin, which caused eighth nerve damage in 17% of exposed infants 3
• Kanamycin, amikacin, and capreomycin presumably share this toxic potential with streptomycin 3
• However, topical otic neomycin has not been associated with ototoxicity when used appropriately with intact tympanic membranes 4

Corticosteroids (Hydrocortisone)

• Low-dose topical corticosteroids are generally considered acceptable during pregnancy when needed for disease control 3
• Intranasal and topical corticosteroids at recommended doses are considered safe in pregnancy, with budesonide having the most extensive safety data 2, 5
• First-trimester exposure carries a slight theoretical increase in cleft lip/palate risk, though recent data are more reassuring than older studies 2

Clinical Recommendations

When prescribing this medication to pregnant women:

• Use only when clearly needed for bacterial otitis externa that requires treatment 1
• Limit treatment duration to 7-10 days maximum as recommended in the labeling 1
• Avoid use if the tympanic membrane is perforated, as this increases systemic absorption and ototoxicity risk 6
• Consider alternative treatments if the infection is mild and can be managed conservatively 6
• Discontinue immediately if sensitization or irritation occurs 1

Alternative Considerations

For pregnant women requiring otic treatment:

• Beta-lactam antibiotics are considered relatively safe in pregnancy with appropriate dose adjustment 6, 7
• Ofloxacin otic solution provides effective treatment without the theoretical aminoglycoside ototoxicity risk and without requiring adjunctive steroids 8
• Macrolides are generally acceptable, though erythromycin and clarithromycin carry certain risks 6, 7

Breastfeeding Considerations

• Hydrocortisone appears in human milk following oral administration, and systemic absorption may occur with topical use 1
• Caution should be exercised when used by nursing women, though the minimal systemic absorption from otic use makes this less concerning than oral administration 1
• Oral corticosteroids are considered compatible with breastfeeding when doses are <20 mg/day of prednisone equivalent 2

Key Clinical Pitfalls to Avoid

• Do not use for longer than 10 days due to risk of fungal overgrowth and prolonged corticosteroid exposure 1
• Do not use with perforated tympanic membranes due to increased ototoxicity risk from aminoglycosides 6
• Verify the diagnosis requires antibiotic treatment rather than simple supportive care 1
• Monitor for signs of sensitization or allergic reaction, which may preclude future use of related aminoglycosides (kanamycin, paromomycin, streptomycin, gentamicin) 1