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Bupropion / naltrexone Pregnancy and Breastfeeding Warnings

Bupropion / naltrexone is also known as: Contrave

Bupropion / naltrexone Pregnancy Warnings

Use is contraindicated. US FDA pregnancy category: X

There are no adequate and well-controlled data in human pregnancy. However, 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. Animal studies have revealed evidence of increased early fetal loss, decreased fetal weights, increased pseudopregnancy, decreased pregnancy rates, and slightly increased fetal malformations and skeletal variations when naltrexone and bupropion were administered separately in doses ranging from 15 to 60 times the maximum recommended human dose (MRHD) of the naltrexone component of this drug, and 2 to 5 times the MRHD of the bupropion component of this drug. 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)." Takeda Pharmaceuticals America, Lincolnshire, IL.

References for breastfeeding information

  1. "Product Information. Contrave (buPROPion-naltrexone)." Takeda Pharmaceuticals America, Lincolnshire, IL.

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