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.
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.
Our Provigil and Nuvigil lawyers are currently accepting cases involving:
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 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.
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:
“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).
If Provigil or Nuvigil caused your baby’s birth defect, filing a lawsuit could allow your family to recover compensation for:
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.
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