Animal studies revealed fetal toxicity in the presence of significant maternal toxicity. Rats dosed at 41 times the maximum recommended human dose (MRHD) during organogenesis showed significant maternal toxicity (i.e., marked reductions in weight gain) and litters with decreased fetal weights, decreased ossification of the forelimbs, and increased number of lumbar ribs. Embryofetal toxicity was not observed in rats dosed at 15 times the MRHD. Rabbits dosed at 40 times the MRHD showed significant maternal toxicity with increases in resorptions and decreased fetal weights; no treatment-related teratogenic effects were observed. There are no controlled data in human pregnancy.

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.

Benefit should outweigh risk

US FDA pregnancy category: Not Assigned

Risk Summary: There are no studies in pregnant women to inform a drug-associated risk; animal studies cannot rule out the potential for fetal harm.

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Not recommended

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

Comments: The effects of this drug on the breastfed infant or on milk production are unknown; however, because of the potential for serious adverse reactions (including sedation in the breastfed infant), maternal use of this drug while breastfeeding is not recommended.

See references