OBJECTIVE: To determine whether exposure during pregnancy to two types of lozenges used for treatment of sore throat [Kalgaron® (Rafa Laboratories, Jerusalem, Israel) or Strepsils® (Boots Healthcare International, Nottingham, UK)] was associated with an increased risk of malformations, spontaneous abortions or decreased birthweight. DESIGN: Prospective, controlled, observational study. STUDY PARTICIPANTS: The study group included 54 women who received Kalgaron® or Strepsils® during the first trimester of pregnancy. The control group included 54 women exposed to non-teratogenic drugs. RESULTS: The rate of major malformations in the study group (3.84%) did not differ from that of the control group (3.92%) [p = 0.98; relative risk 0.98, 95% confidence interval 0.14 to 6.7]. The rate of minor malformations in the study group (1.92%) did not differ statistically from that of the control group (0%) [p = 0.32]. There were also no statistically significant differences in birthweight, rate of live births and rate of spontaneous abortions among the two groups. CONCLUSIONS: The use of Kalgaron® or Strepsils® during pregnancy was not associated with an increased risk of malformations, spontaneous abortions or decreased birthweight. However, larger studies are needed to confirm the safety of these medications during pregnancy.
OBJECTIVE: To determine whether exposure during pregnancy to two types of lozenges used for treatment of sore throat [Kalgaron® (Rafa Laboratories, Jerusalem, Israel) or Strepsils® (Boots Healthcare International, Nottingham, UK)] was associated with an increased risk of malformations, spontaneous abortions or decreased birthweight. DESIGN: Prospective, controlled, observational study. STUDY PARTICIPANTS: The study group included 54 women who received Kalgaron® or Strepsils® during the first trimester of pregnancy. The control group included 54 women exposed to non-teratogenic drugs. RESULTS: The rate of major malformations in the study group (3.84%) did not differ from that of the control group (3.92%) [p = 0.98; relative risk 0.98, 95% confidence interval 0.14 to 6.7]. The rate of minor malformations in the study group (1.92%) did not differ statistically from that of the control group (0%) [p = 0.32]. There were also no statistically significant differences in birthweight, rate of live births and rate of spontaneous abortions among the two groups. CONCLUSIONS: The use of Kalgaron® or Strepsils® during pregnancy was not associated with an increased risk of malformations, spontaneous abortions or decreased birthweight. However, larger studies are needed to confirm the safety of these medications during pregnancy.