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Updated: Apr 15, 2026

Comprehensive Evaluation of the Effectiveness and Safety of Placenta-Targeted Drug Delivery Using Three Complementary Methods
Published on: September 10, 2018
Evaluating the potential effect on fetal tissue after exposure to granisetron during pregnancy
Judith A Smith1, Justin M Julius2, Anjali Gaikwad1
1Department of Gynecology, Obstetrics & Reproductive Sciences, UT Health-University of Texas Medical School at Houston, Houston, TX, United States.
Abstract:
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.
Insights
Granisetron exposure at 30 ng/mL may induce up to 10% apoptosis in fetal cardiac tissue. Lower concentrations (3 ng/mL) showed no detectable toxicity in fetal tissues, warranting further clinical significance evaluation.
Area of Science:
- Obstetrics and Gynecology
- Pharmacology
- Developmental Toxicology
Background:
- Granisetron is a 5-HT3 receptor antagonist used to prevent nausea and vomiting.
- Assessing fetal tissue toxicity of medications during pregnancy is crucial for maternal and infant safety.
Purpose of the Study:
- To investigate the potential toxic effects of granisetron on human fetal tissues at clinically relevant concentrations.
- To evaluate granisetron's impact on cell cycle progression and apoptosis in primary fetal cells.
Main Methods:
- Primary cells from human fetal organs (16-19 weeks gestation) were exposed to granisetron (3 ng/mL and 30 ng/mL).
- Cell cycle progression was analyzed using flow cytometry.
- Apoptosis was assessed by detecting major apoptotic proteins via ELISA.
Main Results:
- Granisetron at 30 ng/mL induced up to 10% apoptosis in fetal cardiac tissue.
- Neither granisetron concentration affected cell cycle progression in any tested fetal tissue.
- No significant alterations in apoptotic proteins were observed in other fetal tissues.
Conclusions:
- High-dose granisetron (30 ng/mL) may pose a risk of apoptosis in fetal cardiac tissue, requiring further clinical evaluation.
- Low-dose granisetron (3 ng/mL) demonstrated no detectable toxicity in the studied fetal tissues.
- Additional research is necessary to confirm these findings and ascertain clinical significance.
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