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Nabilone Pregnancy and Breastfeeding Warnings

Nabilone is also known as: Cesamet

Nabilone Pregnancy Warnings

Teratogenicity has not been demonstrated in animals given doses up to 150 times the human dose. However, dose-related developmental toxicity occurred in animals as evidenced by increased embryo lethality, fetal resorptions, decreased fetal weights, and pregnancy disruptions. Postnatal toxicity and hypothermia in offspring also were observed in some animals. Animal studies have not shown any effect on fertility and reproductive performance with doses up to 150 times the human dose. There are no controlled data in human pregnancy. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk to the fetus. US FDA pregnancy category: C

See references

Nabilone Breastfeeding Warnings

Use of this drug by breastfeeding mothers is not recommended. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: Some cannabinoids are excreted in breast milk.

This drug is known to have an inhibitory effect on prolactin release, which may have contributed to reduced milk production observed in rats given doses 150 times the maximum recommended human dose.

See references

References for pregnancy information

  1. "Product Information. Cesamet (nabilone)." Valeant Pharmaceuticals, Costa Mesa, CA.

References for breastfeeding information

  1. "Product Information. Cesamet (nabilone)." Valeant Pharmaceuticals, Costa Mesa, CA.

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