Benefit should outweigh risk

US FDA pregnancy category: Not Assigned

Risk Summary: There is insufficient data to determine a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; animal data has shown maternal and fetal toxicities at doses 4 times and greater the maximum recommended human dose (MRHD) and teratogenicity at 5 times and greater MRHD.

Comments:
-A pregnancy registry has been established to monitor pregnancy outcomes; healthcare providers are encouraged to register pregnant patients or pregnant women may enroll themselves at 1-877-283-6220 or www.SunosiPregnancyRegistry.com
-Women of childbearing potential and their patterns should use effective contraception during therapy.

Administration to pregnant rats at doses 1, 4, and 19 times the maximum recommended human dose (MRHD) have shown maternal (hyperactivity, significant decreases in body weight, weight gain, and food consumption) and fetal (increased incidence of early resorption and postimplantation loss and decreased fetal weight) toxicity at 4 times and greater the MRHD. Teratogenicity was observed at 19 times the MRHD. Maternal toxicity was observed in pregnant rabbits receiving 10 times the MRHD and teratogenicity was observed at 5 times and greater the MRHD. Administration to pregnant rats at 7 times or greater the MRHD from gestation day 7 through lactation day 20 showed maternal and fetal toxicities and developmental toxicities in the offspring after lactation day 20 (decreased weight and weight gain and delayed sexual maturation). 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.

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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.

Benefit should outweigh risk

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

Comments:
-Monitor breastfed infants for adverse reactions such as agitation, insomnia, anorexia, and reduced weight gain.
-Some authorities advise that if this drug is required by the mother, it is not a reason to discontinue breastfeeding; other authorities advise that a decision should be made to discontinue breastfeeding or abstain from therapy as a risk to the breastfed infant cannot be excluded.

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