Use is not recommended unless the benefit outweighs the risk to the fetus

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

Risk Summary: There is insufficient data in pregnant women to inform a drug associated risk of adverse pregnancy outcomes; there have been reports of intrauterine growth restriction and spontaneous abortion associated with use of this drug. In animal studies, developmental toxicity has been observed at clinically relevant plasma exposures.

Comments:
-A pregnancy registry has been established to monitor treatment outcomes; healthcare providers are encouraged to register pregnant patients, and pregnant women are encouraged to enroll themselves: Phone: 1-866-404-4106.
-Some authorities contraindicate use of this drug during pregnancy and recommend a negative pregnancy test within a week prior to starting treatment.
-Females who are using a hormonal method of contraception should be advised to use an additional barrier method or an alternative non-hormonal method of contraception during treatment and for 1 (US) or 2 (AU) months after discontinuation.

Based on animal data, this drug may cause fetal harm. In animal studies, developmental toxicity (increased embryofetal and offspring mortality, decreased fetal growth) has been observed at clinically relevant plasma exposures. Interim data from the pregnancy registry shows the rate of major congenital malformations (e.g. cardiac anomalies, microcephaly) with armodafinil/modafinil to be approximately 17.3% compared to 3% in the general population. Additionally, there have been reports of spontaneous abortions and intrauterine growth restriction associated with use of this drug during pregnancy. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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.

See references

The amount of drug excreted into breast milk is estimated to be very low (5.5% of the maternal dosage). In one small case control study, no adverse effects were observed leading the authors to conclude the risk for effects in breastfed infants is low. However, some authorities report infant growth retardation has been associated with use of this drug during breastfeeding.

Benefit should outweigh risk

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

Comments: This drug should be used during breastfeeding only if the benefit justifies the potential risk of growth retardation to the infant.

See references