Lozenges Are Likely Safe During Pregnancy Based on Limited Evidence
Based on a small prospective study, throat lozenges (Kalgaron® and Strepsils®) used during the first trimester showed no increased risk of major malformations, spontaneous abortions, or decreased birthweight compared to controls, though larger studies are needed for definitive safety confirmation. 1
Evidence Quality and Limitations
The only direct evidence on throat lozenges in pregnancy comes from a single pilot study of 54 women exposed to two specific lozenge brands during the first trimester 1. This study found:
- Major malformation rate of 3.84% in the lozenge group versus 3.92% in controls (not statistically different) 1
- No significant differences in birthweight, live birth rates, or spontaneous abortion rates 1
- The study authors explicitly acknowledge that larger studies are needed to confirm safety 1
Critical Context: Over-the-Counter Medications in Pregnancy
The broader literature on over-the-counter medications during pregnancy provides important context:
- An estimated 10% or more of birth defects result from maternal drug exposure, making careful evaluation essential 2
- Over-the-counter products should not be assumed safe simply because they are available without prescription 3
- The benefit of any medication should outweigh the risk to the fetus 2
Practical Recommendations
For sore throat treatment during pregnancy, consider this approach:
- First-line: Non-pharmacologic measures - Use saline gargles, warm fluids, and humidification before considering lozenges 4
- If lozenges are needed: The limited available data suggest they are probably safe, particularly after the first trimester when organogenesis is complete 1
- Avoid herbal lozenges: Herbal products lack rigorous safety studies in pregnancy and should not be assumed safe for the fetus 5, 3
- Check active ingredients: If lozenges contain antihistamines, cetirizine or loratadine are preferred options with extensive safety data 4, 6
Common Pitfalls to Avoid
- Do not assume "natural" or herbal lozenges are safer - they may contain pharmacologically active compounds with unknown fetal effects 5, 7
- Avoid lozenges containing NSAIDs after 28 weeks gestation due to risks of oligohydramnios and ductus arteriosus closure 8
- Be cautious with lozenges containing diphenhydramine due to lingering concerns about cleft palate association 4