Use is not recommended

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk Summary: Pharmacovigilance data with the individual components of this drug have not demonstrated a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; 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, and this product should be discontinued.
-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 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.

See references

The average daily infant exposure (assuming 150 mL/kg daily consumption) to bupropion and its active metabolites during lactation has been estimated at 2% of the maternal weight adjusted dose based on a study in 10 women. Postmarketing reports have described seizures in breastfed infants. The relationship of bupropion exposure and these seizures is unclear.

Use is not recommended

Excreted into human milk: Yes

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