FDA Petition To Require Contraindicating Use of Modafinil (PROVIGIL and Generics) and Armodafinil (NUVIGIL) During Pregnancy
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Public Citizen petitioned the Food and Drug Administration (FDA) to promptly require contraindicating the use of modafinil (PROVIGIL and generics) and armodafinil (NUVIGIL) during pregnancy and in females of reproductive potential who are not using effective nonhormonal contraceptives, and to add boxed warnings regarding the potential embryofetal toxicity of both drugs.
May 28, 2025, FDA acknowledgement letter.