Drugs

Group Seeks Warnings on Nuvigil, Provigil

Advocacy group Public Citizen has petitioned FDA to take immediate action to protect unborn children from potential harm caused by the popular wakefulness-promoting drugs Provigil (modafinil) and Nuvigil (armodafinil). The petition urges FDA to contraindicate the use of these drugs, which are made by Apotex, and any approved generics during pregnancy, citing alarming data allegedly linking them to major birth defects.

Modafinil and armodafinil are FDA-approved to treat excessive sleepiness associated with conditions like narcolepsy, shift work disorder, and obstructive sleep apnea. However, the drugs are frequently prescribed off-label for a range of other conditions, including attention-deficit hyperactivity disorder (ADHD), multiple sclerosis, and Parkinson’s disease, the group says.

The petition says that despite evidence of serious risks to developing fetuses, the drugs’ current labels do not contraindicate use during pregnancy. Public Citizen argues this omission puts patients and unborn children at unacceptable risk. “Fetal developmental toxicity and death due to modafinil and armodafinil exposure during pregnancy occurred at clinically relevant doses in animal studies,” the group says. “This likely explains the increased prevalence of congenital malformations in the interim results of the U.S. pregnancy registry.”

Among the most concerning findings, Public Citizen says, are results from the FDA-mandated Nuvigil and Provigil Pregnancy Registry. An interim report from 2018 submitted to the United Kingdom’s Medicines and Healthcare Products Regulatory Agency indicated a 15% rate of major congenital malformations among babies exposed to the drugs in utero — five times higher than the 3% rate in the general U.S. population, it says. The report also noted a 5% prevalence of heart defects in exposed infants, compared to 1% in the broader population.

In addition to banning use during pregnancy, Public Citizen is calling on FDA to contraindicate use in women who may become pregnant and are using hormonal birth control, as modafinil and armodafinil are known to reduce the effectiveness of these contraceptives. The group also wants the agency to mandate boxed warnings to emphasize the risks of embryofetal toxicity, noting that similar regulatory actions have already been taken by authorities in Australia, Canada, Ireland, and the United Kingdom since 2019.

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Gupta Raises Concerns About Overton’s Independence, Ideology

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