Evaluating the potential effect on fetal tissue after exposure to granisetron during pregnancy

•Observed up to 10% apoptosis in fetal cardiac tissue at granisetron 30 ng/mL.•At 3 ng/mL granisetron concentration, there was no effect on fetal tissue.•Based on this study concentrations at 3 ng/mL or below would be safe during pregnancy.•The clinical significance of study findings needs further evaluation.

The objective of this study was to elucidate the possible toxic effects on the fetal tissues after exposure to two clinically relevant concentrations of granisetron. Primary cells were isolated from human fetal organs of 16–19 weeks gestational age and treated with 3 ng/mL or 30 ng/mL of granisetron. Cell cycle progression was evaluated by flow cytometry. ELISA was used to detect alterations in major apoptotic proteins.Up to 10% apoptosis in cardiac tissue was observed following treatment with 30 ng/mL granisetron. Neither concentration of granisetron caused alteration in cell cycle progression or alterations in apoptotic proteins in any of the other tissues.At 30 ng/mL granisetron concentration had the potential to induce up to 10% apoptosis in cardiac tissue; clinical significance needs further evaluation. At granisetron 3 ng/mL there was no detectable toxicity or on any fetal tissue in this study. Further research is needed to confirm these preliminary findings and determine if clinically significant.