Can pregnant women take ivermectin?

Ivermectin Use During Pregnancy

Ivermectin should not be used during pregnancy since safety in pregnancy has not been established, according to FDA labeling. 1

Safety Concerns and Evidence

• Ivermectin has been shown to be teratogenic in animal studies (mice, rats, and rabbits) when given at doses 0.2-8.1 times the maximum recommended human dose, with developmental effects including cleft palate and clubbed forepaws 1
• The FDA drug label explicitly states: "Ivermectin should not be used during pregnancy since safety in pregnancy has not been established" 1
• While teratogenic effects were found at doses that were also toxic to pregnant animals, suggesting ivermectin may not be selectively fetotoxic, there are insufficient well-controlled studies in pregnant women to establish safety 1

Current Guidelines and Practices

• Pregnant women are systematically excluded from community-directed treatment programs with ivermectin for conditions like onchocerciasis due to safety concerns 2
• UK guidelines for management of eosinophilia in returning travelers and migrants suggest avoiding ivermectin in the first trimester of pregnancy, though the WHO suggests it can be used in second/third trimesters 3
• The CDC's sexually transmitted diseases treatment guidelines note that ivermectin likely poses a low risk to pregnant women but recommends permethrin as the preferred treatment for conditions like scabies during pregnancy 3

Research Evidence

• A 2020 systematic review and meta-analysis evaluated data from 893 women with 899 pregnancy outcomes and found insufficient evidence to conclude on ivermectin's safety profile during pregnancy 4
• The review could not determine whether exposure to ivermectin during pregnancy increases the risk of spontaneous abortions, stillbirths, or congenital anomalies due to very low certainty of evidence 4
• A randomized open-label trial in Uganda including 834 pregnant women reported one abortion in the albendazole group and three stillbirths in the combination ivermectin-albendazole group, with one baby born with congenital abnormalities in the ivermectin group 5

Special Considerations

• Early, undetected, and undeclared pregnancies are being systematically exposed to ivermectin in practice during mass drug administration campaigns 2
• There is a need for more robust evidence regarding ivermectin use in pregnancy, including establishing pregnancy registries for women inadvertently exposed to ivermectin during pregnancy 2
• Patients with severe liver disease may be at higher risk for ivermectin toxicity 6

Breastfeeding Considerations

• Ivermectin is excreted in human milk in low concentrations 1
• Treatment of breastfeeding mothers should only be undertaken when the risk of delayed treatment outweighs the possible risk to the newborn 1
• One study measuring ivermectin concentration in breastmilk found levels ranging from 1.4 to 20.8 ng/ml after a single dose, with estimated infant exposure at 0.55% of the maternal dose, which is below WHO thresholds for safe breastfeeding 7

Conclusion

Based on the FDA drug labeling and available evidence, ivermectin should be avoided during pregnancy due to insufficient safety data and potential risks. Alternative treatments should be considered for pregnant women requiring antiparasitic therapy, and efforts should be made to prevent inadvertent treatment of pregnant women during mass drug administration campaigns.