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Sore Throat Treatment during Pregnancy : A Prospective, Controlled, Pilot Study.
M Berkovitch1, R Greenberg, L Gendler
1Clinical Pharmacology and Toxicology Unit, Assaf Harofeh Medical Center, Zerifin, Israel, mberkovitch@asaf.health.gov.il.
Sore throat lozenges Kalgaron® and Strepsils® appear safe for pregnancy. Studies show no increased risk of birth defects, miscarriage, or low birth weight for mothers using these lozenges during early pregnancy.
Area of Science:
- Obstetrics and Gynecology
- Pharmacovigilance
- Teratology
Background:
- Sore throat is a common ailment during pregnancy.
- The safety of over-the-counter medications, including lozenges, during pregnancy requires careful evaluation.
- Kalgaron® and Strepsils® are commonly used for sore throat relief.
Purpose of the Study:
- To assess the potential association between the use of Kalgaron® or Strepsils® lozenges during the first trimester of pregnancy and adverse pregnancy outcomes.
- To investigate risks of malformations, spontaneous abortions, and decreased birthweight.
Main Methods:
- Prospective, controlled, observational study design.
- Involved 54 pregnant women using Kalgaron® or Strepsils® in the first trimester (study group).
- A control group of 54 pregnant women exposed to non-teratogenic drugs was included for comparison.
Main Results:
- No statistically significant difference in the rate of major malformations between the study group (3.84%) and the control group (3.92%).
- No significant difference in minor malformations between groups (1.92% vs. 0%).
- No significant differences observed in birthweight, live birth rates, or spontaneous abortion rates.
Conclusions:
- Use of Kalgaron® or Strepsils® during pregnancy is not linked to increased risks of malformations, spontaneous abortions, or reduced birthweight.
- Larger studies are recommended to further confirm the safety profile of these lozenges in pregnant populations.
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