Pregnancy outcome following gestational exposure to echinacea - A prospective controlled study

Background: Echinacea products are among the most popular phytomedicines on the North American market. Since at least half of all pregnancies are unpl anned, many women inadvertently use echinacea in their first trimester. Pre sently, there is a paucity of information regarding the gestational safety of this herb. The primary objective of this study was to evaluate the safet y of echinacea in pregnancy when used for upper respiratory tract ailments. Patients and Methods: The study group consisted of women who were prospecti vely followed up after contacting the Motherisk Program regarding the gesta tional use of echinacea. This cohort was disease-matched to women exposed t o nonteratogenic agents by maternal age, alcohol, and cigarette use. Rates of major and minor malformations between the groups were compared. Results: A total of 206 women were enrolled in the study group after using echinacea products during pregnancy; 112 women used the herb in the first t rimester. There were a total of 195 live births, including 3 sets of twins, 1? spontaneous abortions, and 1 therapeutic abortion. Six major malformati ons were reported, including 1 chromosomal abnormality, and 4 of these malf ormations occurred with echinacea exposure in the first trimester. In the c ontrol group, there were 206 women with 198 live births, 7 Spontaneous abor tions, and 1 therapeutic abortion. Seven major malformations were reported. There were no statistical differences between the study and control groups for any of the end points analyzed. Conclusions: This first prospective study suggests that gestational use of echinacea during organogenesis is not associated with an increased risk for major malformations.