Stimulants Provigil and Nuvigil Causing Birth Defects.

Drug Liability Attorneys in New York City

Teva Pharmaceuticals, the manufacturer and distributor of the stimulants Provigil and Nuvigil have warned mothers of birth defects associated with these prescription medications. Urgent warnings were added to the medications in Europe and Canada issued letters to doctors and the public. As of October 2019, Teva nor the FDA has warned pregnant women in the United States. These drugs are often prescribed to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). At Rheingold Giuffra Ruffo & Plotkin LLP, our New York defective drug lawyers are investigating these claims based on their decades of experience with Bendectin and Abilify litigation.

Major Malformation and Birth Defect Detection Reported In A Journal Of American Medical Association Research Letter

January 28, 2020, JAMA Research Letter noted that pregnant Provigil users were noted to have an increased incidence in congenital malformations, major malformations and birth defects in their children. The authors Per Damkier, MD, PhD, and Anne Broe, MD, PhD studied births in Denmark and released their findings in “First-Trimester Pregnancy Exposure to Modafinil and Risk of Congenital Malformations.” They reported a 12% incidence in Provigil/Nuvigil users as opposed to a 3.9% incidence in non-users.

Health Canada Issues Warning Letters for Provigil And Nuvigil Birth Defects

With the discovery of the stimulant drugs Provigil and Nuvigil associated with birth defects, many doctors have stopped prescribing these to pregnant women. The drugs’ active chemicals pass through the placenta while in utero. Teva Pharmaceuticals discovered the potential correlation and continued to warn only Health Canada and European countries to discontinue the use in pregnant women, but failed to warn the United States of these findings. Now Teva Pharmaceuticals is doing an internal investigation. However, all records of the findings remain confidential.

Birth defects from taking Provigil and Nuvigil while pregnant may include:

  • Cleft lip or palate (orofacial clefts).
  • Hypospadias.
  • Congenital heart defects.
  • Microcephaly

Our litigation partners personally work with clients to determine the extent of the monetary damage this drug has caused them, and what legal remedies are at their disposal.


Our New York dangerous drug lawyers perform a rigorous investigation of the impact this injury has had on clients and their families, both medically and financially. We have access to expert witnesses in pharmacology and other relevant fields who help us determine how dangerous drugs contributed to your injuries and who is liable for the damages. We offer every client personal, individual and attentive client service and dedication to results. Furthermore, through our extensive litigation against Mega pharmaceutical companies (such as Teva pharmaceuticals), we are experienced with lawsuits involving dangerous drugs, and foreign pharmaceutical. Our New York defective drug attorneys are able to handle a wide range of drug liability claims, including those involving Dangerous drugs that cause defects. Call (888) 260-0473 for a free case evaluation.

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