Provigil and Nuvigil Lawsuit

Women who take Provigil or Nuvigil during pregnancy may be more likely to have a baby with serious birth defects. Consider filing a Provigil and Nuvigil lawsuit if either of these sleep disorder medications harmed your child.

Contact a Provigil/Nuvigil Birth Defects Lawyer Today!

The nationwide law firm of Bernstein Liebhard LLP is interested in hearing from families who suspect Provigil or Nuvigil caused their babies’ birth defects.  If you would like to learn more about a Provigil and Nuvigil lawsuit, please fill out the form on this page, or contact our office directly by calling (888) 994-5118.

Provigil and Nuvigil Birth Defects

Our Provigil and Nuvigil lawyers are currently accepting cases involving:

  • Microcephaly
  • Cleft lip or palate (orofacial clefts)
  • Hypospadias
  • Congenital heart defects, including but not limited to:
    • Atrial septal defects
    • Atrioventricular septal defects
    • Coarctation of the aorta
    • Double-outlet right ventricle
    • D-transposition of the great arteries
    • Ebstein anomaly
    • Hypoplastic left heart syndrome
    • Interrupted aortic arch
    • Pulmonary atresia
    • Single ventricle
    • Tetralogy of Fallot
    • Total anomalous pulmonary venous return
    • Tricuspid atresia,
    • Tuncus arteriosus
    • Ventricular septal defects
  • Death resulting from any of the above-mentioned birth defect.

Provigil and Nuvigil: Background

The U.S. Food & Drug Administration (FDA) has approved Provigil (modafinil) and Nuvigil (armodafinil)  to prevent excessive daytime sleepiness and promote wakefulness in people suffering from:

  • Sleep apnea
  • Narcolepsy
  • Shift work sleep disorder

Nuvigil has a slightly different chemical structure than Provigil, but both are considered equally effective. However, they won’t cure these disorders and should not be used in place of adequate sleep.

No one really knows how Provigil and Nuvigil work; however, it’s likely they increase the body’s sensitivity to dopamine, a neurotransmitter associated with wakefulness. While neither is considered a stimulant, Provigil and Nuvigil do have stimulant-like effects on the central nervous system.

Provigil/Nuvigil and Pregnancy

Provigil and Nuvigil reduce the effectiveness of hormonal contraceptives, including birth control pills, NuvaRing, Nexplanon implant, Depo Provera injections, and hormonal IUDs. Therefore, women of child-bearing age should use an additional barrier method or an alternative non-hormonal method of birth control during treatment, and for one month after treatment ends.

The FDA has designated Provigil and Nuvigil as Pregnancy Category C Drugs:

“Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.”

Because developmental toxicity was observed in animal studies, the FDA established the Nuvigil/Provigil Pregnancy Registry to track pregnancy and fetal outcomes. The registry has since enrolled hundreds of women who took at least one dose of Nuvigil or Provigil at least 6 weeks prior to conception and/or during their pregnancy.

Provigil/Nuvigil Birth Defects Warnings

The Nuvigil/Provigil Pregnancy Registry publishes an annual report each year.

The 2018 report apparently suggested a higher rate of major birth defects and other adverse reactions among children exposed to Provigil or Nuvigil in utero.

So far, no action has been taken in the United States. But in June 2019, healthcare providers in Canada, Ireland, and France were warned against prescribing the medications to pregnant women, as well as any woman who planned on becoming pregnant.

The warnings also advised clinicians to ensure women of child-bearing potential:

  • Had a negative pregnancy test within a week of starting Nuvigil or Provigil
  • Inform these patients that they MUST use effective non-hormonal contraception during treatment, and for two weeks after treatment ends.

“The frequency of major congenital anomalies (17.3%) and cardiac anomalies (4%) associated with the exposure to modafinil and/or armodafinil was above the frequency observed in the general population (3% and 1%, respectively),” the HealthCanada Safety Alert noted. “There have also been post-marketing reports of congenital malformations and of low fetal growth, as well as cases of babies who failed to thrive (poor physical development).

Learn More About Filing a Provigil and Nuvigil Lawsuit

If Provigil or Nuvigil caused your baby’s birth defect, filing a lawsuit could allow your family to recover compensation for:

  • Past and future medical bills.
  • Past and future lost wages resulting from their care.
  • Expenses related to special education and rehabilitative therapies.
  • Pain and Suffering.
  • Emotional distress.
  • Wrongful death, when birth defects contributed to a child’s death.

If you’d like to discuss filing a Provigil and Nuvigil lawsuit with a member of our legal team, simply submit the form on this page or call (888) 994-5118 to arrange for your free, no-obligation case review.

  1. FDA (2007) “PROVIGIL (modafinil) Tablets [C-IV]”
  2. FDA (February 2017) “NUVIGIL: Highlights of Prescribing information”
  3. S. Dept. of Health & Human Services (May 2008) “FDA Pregnancy Categories”
  4. gov (August 2018) “Nuvigil/Provigil Pregnancy Registry”
  5. HealthCanada (June 2019) “ALERTEC (modafinil) and the Risk of Congenital Anomalies”
  6. Teva Pharmaceuticals Ireland (June 2019) “Modafinil: potential risk of congenital malformations when administered during pregnancy”—modafinil99170c2697826eee9b55ff00008c97d0.pdf?sfvrsn=0
  7. Hypersomnia Foundation (July 2019) “In Case You Missed It!”
Last Modified: July 18, 2019

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