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Varenicline Pregnancy and Breastfeeding Warnings

Varenicline is also known as: Champix, Chantix

Varenicline Pregnancy Warnings

Varenicline has been shown to have nonteratogenic adverse effects on the fetus in animal reproduction studies at doses up to 23 to 50 times the recommended human dose. Reduced fetal weights were reported in pregnant rabbits and the offspring of pregnant rats showed decreases in fertility and increases in auditory startle response.

Varenicline has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of teratogenicity. Animal studies have reported reduced fetal weights, decreased fertility, and increased auditory startle response. There are no controlled data in human pregnancy. Varenicline should only be administered during pregnancy when the potential benefit outweighs the risk.

Varenicline Breastfeeding Warnings

There are no data on the excretion of varenicline into human milk. The effects in the nursing infant are unknown. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Animal studies have reported that varenicline can be transferred to nursing pups.

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