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Cannabidiol Pregnancy and Breastfeeding Warnings

Cannabidiol is also known as: Epidiolex

Medically reviewed by Drugs.com. Last updated on Oct 11, 2018.

Cannabidiol Pregnancy Warnings

Developmental toxicities that were observed in animal studies at the highest dose tested (250 mg/kg/day) included increased embryofetal mortality in rats and decreased fetal body weights and increased fetal structural variations in rabbits. In rabbits, this was also associated with maternal toxicity. At the mid to high doses in rats, decreased growth, delayed sexual maturation, neurobehavioral changes, and adverse effects on the male reproductive system (small tests in adult offspring) were observed. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: There are no adequate data on the developmental risks in pregnant women; developmental toxicity was observed in animals at maternal plasma exposures similar or greater than expected in humans.

Comments:
-A pregnancy registry is available that monitors pregnancy outcomes in women exposed to antiepileptic drugs and to provide information on the effects of in utero exposure; pregnant patients should be encouraged to enroll: North American AED Pregnancy Registry: US toll free number: 1-888-233-2334; Website: http://www.aedpregnancyregistry.org/

See references

Cannabidiol Breastfeeding Warnings

Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

See references

References for pregnancy information

  1. "Product Information. Epidiolex (cannabidiol)." Greenwich Biosciences Inc, Carlsbad, CA.

References for breastfeeding information

  1. "Product Information. Epidiolex (cannabidiol)." Greenwich Biosciences Inc, Carlsbad, CA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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