Weitz & Luxenberg is accepting cases involving birth defects in children whose mothers used wakefulness medications Provigil (modafinil) or Nuvigil (armodafinil) during pregnancy.

Provigil and Nuvigil Taken During Pregnancy Can Cause Birth Defects in Children

Provigil and Nuvigil are approved for use in adults to improve wakefulness in those with narcolepsy, sleep apnea, and “shift work disorder,” the term for those who may experience excessive sleepiness due to working overnight or other nontraditional shifts.

After developmental toxicity was observed in animal studies, the U.S. Food and Drug Administration (FDA) requested a Pregnancy Registry to characterize the pregnancy and fetal outcomes of Provigil (modafinil) and Nuvigil (armodafinil) exposure during pregnancy.

While no action has yet been taken in the United States, on June 7, 2019, Teva Pharmaceuticals Ireland issued a DHPC (Direct Healthcare Professional Communication) in agreement with the European Medicines Agency (EMA) and Health Products Regulatory Authority (HPRA), stating that “[b]ased on post-marketing reports from the US Nuvigil® and Provigil® Pregnancy Registry and other spontaneous sources, the use of modafinil during pregnancy is suspected to cause congenital malformations.” (1)

In this communication Teva instructed healthcare professionals that both drugs should not be used during pregnancy, and that women with the ability to have children must use effective contraception during treatment with and for at least two months after stopping Provigil or Nuvigil. The DHPC instructed that since modafinil may reduce the effectiveness of oral contraceptives, other or additional methods of contraceptives should be discussed. Health Canada had also issued warnings against the use of Nuvigil and Provigil in women who are pregnant or may become pregnant.

Weitz & Luxenberg is accepting cases of children exposed to Provigil or Nuvigil in utero and born with birth defects, including:

  • 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.
    • Truncus arteriosus.
    • Ventricular septal defects.
  • Death due to any of the above.

W&L Can Help Children Harmed by Provigil or Nuvigil

Attorneys in Weitz & Luxenberg’s Drugs & Medical Device Litigation unit are interested in hearing from mothers who used Provigil or Nuvigil while pregnant and had children born with a birth defect. Weitz & Luxenberg is also interested in hearing from young adults who were born with a congenital defect after their mother used Provigil or Nuvigil during their gestation.

An experienced Weitz & Luxenberg attorney can help you and your family explore your legal options, including if you may be entitled to financial compensation for medical expenses, pain and suffering, and lost wages.

Co-chairs Ellen Relkin and Paul Pennock lead a team of attorneys who have won verdicts and settlements of more than $12 billion. The lawsuits were filed and won on behalf of victims harmed by defective drugs and medical devices. *

Contact W&L by calling (800) 476-6070 or by using the online form to learn about your legal options.

*Past performance is no guarantee of future results. The settlements in which Weitz & Luxenberg played leadership roles included patients not represented by W&L.

  1. Teva Pharmaceuticals Ireland. (2019, June 7). Direct Healthcare Professional Communication (DHPC). Modafinil: potential risk of congenital malformations when administered during pregnancy. Retrieved from http://www.hpra.ie/docs/default-source/default-document-library/important-safety-information---modafinil99170c2697826eee9b55ff00008c97d0.pdf?

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