Narcolepsy Drugs Linked to Fetal Malformations- JAMA Study
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The narcolepsy drugs modafinil (Provigil) and armodafinil (Nuvigil) were both associated with major congenital malformations, a post-marketing report showed.

Of 102 prospective live births in the U.S. Provigil/Nuvigil Pregnancy Registry, 13% had major congenital malformations, considerably above the prevalence of about 3% in the general population, according to authors.

"Although the available data are inconclusive for causality, the potential increased risk of major congenital malformations provides an impetus for health care professionals to enhance the benefit-risk monitoring of modafinil and/or armodafinil use in pregnant individuals and individuals who may become pregnant," researchers wrote in JAMA Internal Medicine.

Four of the newborns with malformations were diagnosed with congenital torticollis; two were diagnosed with hypospadias, and three with congenital heart defects, making the cardiac malformation prevalence 3%, compared with about 1% in the general population.

These data are important to manage care for individuals who could become pregnant who may be prescribed modafinil or armodafinil, noted authors.

Modafinil and armodafinil are indicated to improve wakefulness in adults with excessive sleepiness associated with obstructive sleep apnea, narcolepsy, or shift work disorder. Modafinil also is used to treat fatigue in multiple sclerosis and other diseases.

FDA-approved labels for the drugs put them in pregnancy category C, citing reports of "intrauterine growth restrictions and spontaneous abortions," as well as animal studies showing fetal structural abnormalities. Both agents "should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus," the labels state.

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