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Bupropion / naltrexone Pregnancy and Breastfeeding Warnings

Bupropion / naltrexone is also known as: Contrave

Medically reviewed by Drugs.com. Last updated on Jun 18, 2018.

Bupropion / naltrexone Pregnancy Warnings

Use is contraindicated

AU TGA pregnancy category: B3
US FDA pregnancy category: X

Risk Summary: Maternal weight loss offers no potential benefit to pregnant women and may result in fetal harm.

Comments:
-If a woman 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; a minimum weight gain and no weight loss is recommended during pregnancy.

Animal studies with the combined product have not been conducted, but separate studies with individual agents have been conducted in both rats and rabbits. Bupropion administration in rats at doses at least 15 times the maximum recommended human dose (MRHD) and rabbits at least 60 times the MRHD during the period of organogenesis did not show teratogenicity; slightly increased fetal malformations and skeletal variations were observed in rabbits at approximately 2 times the MRHD and greater. Naltrexone administration increased the incidence of early fetal loss in rats receiving 9 times the MRHD and rabbits receiving 36 times the MRHD; no evidence of teratogenicity was observed with administration up to 60 (rats) and 120 (rabbits) times MRHD during the period of organogenesis. 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.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "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.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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

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