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Modafinil Pregnancy and Breastfeeding Warnings

Modafinil is also known as: Provigil

Medically reviewed on April 23, 2018.

Modafinil Pregnancy Warnings

AU: This drug is contraindicated during pregnancy.
UK: This drug is not recommended during pregnancy or in women of childbearing potential unless they are using effective contraception.
US: This drug should be used during pregnancy only if the potential benefit justifies the possible risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Comments: There is a potential increased risk of pregnancy when using steroidal contraceptives (e.g., ethinyl estradiol) as their effectiveness may be impaired due to enzyme induction activity; female patients with reproductive potential should use alternative or concomitant contraception methods during treatment and for 1 to 2 months after treatment discontinuation.

Intrauterine growth restriction and spontaneous abortion have been reported with this drug and armodafinil (R-enantiomer of this drug). Some animal studies have revealed embryofetal toxicity and lethality in the absence of maternal toxicity at clinically relevant exposures, while others demonstrated no adverse effects on embryofetal development. An increase in the time to mate was observed in one animal study; no other fertility effects were observed. There are no controlled data in human pregnancy.

To collect information on the pregnancy outcomes of women exposed to this drug, a pregnancy registry has been established. Healthcare providers are encouraged to register pregnant patients, and pregnant women may enroll themselves by calling 1-866-404-4106 (toll free).

AU TGA pregnancy category B3: 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 shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Modafinil Breastfeeding Warnings

AU, UK: This drug should not be used during breastfeeding.
US: Caution is recommended.

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

Comments:
-In an animal study, drug concentration in milk was about 11.5 times higher than in plasma.
-The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Provigil (modafinil)." Cephalon, Inc, West Chester, PA.

References for breastfeeding information

  1. "Product Information. Provigil (modafinil)." Cephalon, Inc, West Chester, PA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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