Benefit should outweigh risk

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

Risk summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Some experts advise against use during pregnancy as the potential risk for humans is unknown.

Embryo-fetal studies in rats and rabbit have not shown adverse effects on fetal development or teratogenicity with doses up to approximately 40 and 51 times the maximum recommended human dose (MRHD), respectively, during the period of organogenesis. Neonatal mortality and a reduction in neonatal weight gain was observed in the presence of maternal toxicity when female rats were dosed at approximately 40 times the MRHD from organogenesis through lactation. This drug crosses the placental barrier in rats and was detected in fetal tissue. Data on a very limited number of exposed pregnancies have not indicated adverse effects on the health of the fetus or newborn infant. There are no controlled data in human pregnancy.

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.

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This drug is readily excreted in the breast milk of rats (milk:plasma ratio of 7.9 at 4 hours post-maternal dose). Reductions in offspring development and weaning index occurred when female rats were dosed at levels 25 times the maximum recommended human dose during lactation; maternal toxicity was observed.

Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-Some experts advise against breastfeeding as a risk to the breastfeeding infant cannot be excluded.

See references