Requests that the FDA require the following actions: (1) Contraindicate the use of modafinil and armodafinil during pregnancy and in females of reproductive potential who are not using effective nonhormonal contraceptives, and (2) Add boxed warnings in the labeling of these drugs due to their potential embryofetal toxicity.
🏛 Food and Drug Administration (FDA)FDA-2025-P-1449
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