Are Cepacol lozenges safe during pregnancy?

What does the evidence say about cepacol during pregnancy?

1. Benzocaine is a local anesthetic in the amino ester class that works by reversibly binding to and inhibiting sodium channels in the neuronal cell membrane. It has been used for the relief of pain associated with pharyngitis, and benzocaine gels, liquids and tablets are FDA approved. 1
2. The signature hazard is methemoglobinemia, marked by cyanosis, hypoxia and shortness of breath that does not improve with oxygen. FDA issued a stringent warning against over-the-counter oral benzocaine products for infants and children younger than 2, and the risk of developing methemoglobinemia increases by almost 20-fold with benzocaine exposure in the previous week. 1
3. The alternative for throat pain has better pregnancy data than the lozenge does. Acetaminophen at recommended dosages has not been shown to increase the chance of birth defects and is not expected to increase the chance of miscarriage, with the guidance being to use it only as needed at the lowest effective dose. 2
4. For anyone nursing, topical benzocaine has not been studied during breastfeeding but is unlikely to affect a breastfed infant when applied away from the breast. It must never be applied to the breast or nipple, because ingestion during nursing has been associated with severe methemoglobinemia in children under 2 years of age. 3
5. On the menthol side, oral peppermint in amounts commonly found in food is likely safe during pregnancy or while breastfeeding, but little is known about whether oral peppermint is safe in medicinal amounts. Peppermint oil should not be applied to the face of infants or young children because inhaling the menthol can cause serious side effects. 4

Is cepacol safe in each trimester?

• First trimester. Sore throats and colds are common early and there is no reason a lozenge has to be the medicated kind. Benzocaine carries an obsolete FDA pregnancy Category C label in StatPearls, which is a marker of limited data rather than a finding of harm.
• Second trimester. If you are using lozenges through a long illness, the detail worth knowing is that the risk of methemoglobinemia rises almost 20-fold if you have been exposed to benzocaine within the previous week. Spacing matters more than any single lozenge.
• Third trimester. Late-pregnancy throat irritation often comes from congestion and mouth-breathing rather than infection. Peppermint in amounts commonly found in food is likely safe in pregnancy, but little is known about oral peppermint in medicinal amounts, which is the honest position on the menthol half of the lozenge too.