Skip to Content

Bupropion / naltrexone Pregnancy and Breastfeeding Warnings

Bupropion / naltrexone is also known as: Contrave

Medically reviewed on June 18, 2018

Bupropion / naltrexone Pregnancy Warnings

Use is contraindicated

US FDA pregnancy category: X

Risk Summary: Maternal weight loss during pregnancy may result in fetal harm.

Comments:
-If a women becomes pregnant while taking this drug, she should be apprised of the potential hazard of maternal weight loss to the fetus.
-Obligatory weight gain is necessary in maternal tissues during pregnancy.

Animal studies with the combined product have not been conducted, but separate studies with bupropion and naltrexone have been conducted in both rats and rabbits. Bupropion administration in dose up to 450 mg/kg/day (rats) and 150 mg/kg/day (rabbits) during the period of organogenesis did not show teratogenicity, but slightly increased fetal malformations and skeletal variations were observed in rabbits at approximately 2 times (25 mg/kg/day) the maximum recommended human dose (MRHD). Naltrexone administration increased the incidence of early fetal loss in rats receiving 15 times the MRHD (30 mg/kg/day or more) and rabbits receiving 60 times the MRHD (60 mg/kg/day or more). Data from the international bupropion Pregnancy Registry (675 first trimester exposures) and a retrospective cohort study using the United Healthcare database (1,213 first trimester exposures) did not show an increased risk for malformations overall. There are no adequate and well-controlled data in human pregnancy.

US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

See references

Bupropion / naltrexone Breastfeeding Warnings

Use is not recommended

Excreted into human milk: Yes

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Contrave (buPROPion-naltrexone)." Orexigen Therapeutics Inc, La Jolla, CA.

References for breastfeeding information

  1. "Product Information. Contrave (buPROPion-naltrexone)." Orexigen Therapeutics Inc, La Jolla, CA.

Further information

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

Hide