Supplemental Petition to the FDA to Require a Pregnancy Contraindication for Modafinil and Armodafinil
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Public Citizen submitted a supplement to its petition to the Food and Drug Administration (FDA) to promptly require an explicit pregnancy contraindication for modafinil and armodafinil. Since the submission of our original petition, a final analysis of data from an FDA-mandated U.S. registry linked exposure to the drugs during pregnancy to a higher rate of major congenital malformations than in the general U.S. population.
See Public Citizen’s other work on modafinil and armodafinil.