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Rifaximin Pregnancy and Breastfeeding Warnings

Rifaximin is also known as: Xifaxan

Rifaximin Pregnancy Warnings

AU: The manufacturer makes no recommendation regarding use during pregnancy. UK: Use is not recommended during pregnancy or in women of childbearing potential not using contraception. US: This drug may cause fetal harm (based on animal data). AU TGA pregnancy category: B1 US FDA pregnancy category: Not assigned. Comments: -Pregnant patients should be apprised of the potential harm to the fetus. -Additional contraceptive precautions recommended; local protocol should be consulted.

Animal studies have revealed evidence of teratogenicity at doses about 0.9 to 5 times (rats) and 0.7 to 33 times (rabbits) the recommended human doses of 600 to 1650 mg/day; effects included cleft palate, agnathia, jaw shortening, hemorrhage, eye partially open, small eyes, brachygnathia, incomplete ossification, and increased thoracolumbar vertebrae. Ocular malformations in rats and rabbits observed at doses that caused reduced maternal body weight gain. There are no controlled data in human pregnancy; no data to inform any drug-related risks. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage. 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.

Rifaximin Breastfeeding Warnings

LactMed: Alternate therapy may be preferred, especially if the nursing infant is premature or younger than 1 month. -AU, UK: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Unknown Comments: -The development and health benefits of human milk feeding should be considered. -Potential side effects in the human milk fed child due to the drug or the mother's underlying condition should be considered. -This drug is poorly absorbed orally and is unlikely to reach breast milk or bloodstream of the nursing infant. -The effects in the nursing infant are unknown; adverse effects are unlikely.

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