Characterization of pregnancies exposed to St. John’s wort and their outcomes: A claims data analysis

Schäfer, Wiebke; Wentzell, Nadine; Schink, Tania; Haug, Ulrike

doi:10.1016/j.reprotox.2021.04.005

Cited by 2 publications

(2 citation statements)

References 41 publications

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“…Well known issues such as phototoxicity ( Onoue et al, 2011 ) and interactions with other medications ( Nicolussi et al, 2020 ) must be taken care of also during administration in pregnancy. Moreover, a few studies which were either prospective ( Kolding et al, 2015 ) or based on data analysis of a national birth cohort ( Moretti et al, 2009 ) or on claim data ( Schäfer et al, 2021 ) seem to suggest an increased risk of fetal malformation in pregnant women exposed to St. John’s wort preparations. While the results are striking, they should be interpreted with caution.…”

Section: Discussionmentioning

confidence: 99%

Advanced in Vitro Safety Assessment of Herbal Medicines for the Treatment of Non-Psychotic Mental Disorders in Pregnancy

et al. 2022

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When confronted with non-psychotic mental disorders, pregnant women often refrain from using synthetic drugs and resort to herbal medicines such as St. John’s wort, California poppy, valerian, lavender, and hops. Nevertheless, these herbal medicines have not yet been officially approved in pregnancy due to lack of safety data. Using a variety of in vitro methods (determination of cytotoxicity, apoptosis induction, genotoxicity, effects on metabolic properties, and inhibition/induction of differentiation) in a commonly used placental cell line (BeWo b30), we were previously able to show that extracts from these plants are likely to be safe at the usual clinical doses. In the present work, we wanted to extend our safety assessment of these herbal medicines by 1) looking for possible effects on gene expression and 2) using the same in vitro methods to characterize effects of selected phytochemicals that might conceivably lead to safety issues. Proteomics results were promising, as none of the five extracts significantly affected protein expression by up- or down-regulation. Protopine (contained in California poppy), valerenic acid (in valerian), and linalool (in lavender) were inconspicuous in all experiments and showed no adverse effects. Hyperforin and hypericin (two constituents of St. John’s wort) and valtrate (typical for valerian) were the most obvious phytochemicals with respect to cytotoxic and apoptotic effects. A decrease in cell viability was evident with hypericin (≥1 µM) and valtrate (≥10 µM), whereas hyperforin (≥3 µM), hypericin (30 µM) and valtrate (≥10 µM) induced cell apoptosis. None of the tested phytochemicals resulted in genotoxic effects at concentrations of 0.1 and 1 µM and thus are not DNA damaging. No decrease in glucose consumption or lactate production was observed under the influence of the phytochemicals, except for valtrate (at all concentrations). No compound affected cell differentiation, except for hyperforin (≥1 µM), which had an inhibitory effect. This study suggests that extracts from St. John’s wort, California poppy, valerian, lavender, and hops are likely to be safe during pregnancy. High plasma concentrations of some relevant compounds—hyperforin and hypericin from St. John’s wort and valtrate from valerian—deserve special attention, however.

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Section: Discussionmentioning

confidence: 99%

Advanced in Vitro Safety Assessment of Herbal Medicines for the Treatment of Non-Psychotic Mental Disorders in Pregnancy

et al. 2022

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“…As for most other phytomedicines, the entire extract has to be considered as the active ingredient (Butterweck and Schmidt, 2007;Nicolussi et al, 2020). A recent study based on data from Germany found that pregnant women mainly used St. John's wort in the first trimester, but simultaneous dispensation of other drugs that favour interactions and the observation of a relatively high rate of non-live births call for a thorough further safety investigation (Schäfer et al, 2021). Valerian (Valeriana officinalis L., Caprifoliaceae) is known for its sleep promoting and anxiolytic properties (Hattesohl et al, 2008).…”

Section: Introductionmentioning

confidence: 99%

Transplacental passage of hyperforin, hypericin, and valerenic acid

et al. 2023

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Safe medications for mild mental diseases in pregnancy are needed. Phytomedicines from St. John’s wort and valerian are valid candidates, but safety data in pregnancy are lacking. The transplacental transport of hyperforin and hypericin (from St. John’s wort), and valerenic acid (from valerian) was evaluated using the ex vivo cotyledon perfusion model (4 h perfusions, term placentae) and, in part, the in vitro Transwell assay with BeWo b30 cells. Antipyrine was used for comparison in both models. U(H)PLC-MS/MS bioanalytical methods were developed to quantify the compounds. Perfusion data obtained with term placentae showed that only minor amounts of hyperforin passed into the fetal circuit, while hypericin did not cross the placental barrier and valerenic acid equilibrated between the maternal and fetal compartments. None of the investigated compounds affected metabolic, functional, and histopathological parameters of the placenta during the perfusion experiments. Data from the Transwell model suggested that valerenic acid does not cross the placental cell layer. Taken together, our data suggest that throughout the pregnancy the potential fetal exposure to hypericin and hyperforin – but not to valerenic acid – is likely to be minimal.

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Characterization of pregnancies exposed to St. John’s wort and their outcomes: A claims data analysis

Cited by 2 publications

References 41 publications

Advanced in Vitro Safety Assessment of Herbal Medicines for the Treatment of Non-Psychotic Mental Disorders in Pregnancy

Advanced in Vitro Safety Assessment of Herbal Medicines for the Treatment of Non-Psychotic Mental Disorders in Pregnancy

Transplacental passage of hyperforin, hypericin, and valerenic acid

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