Langer & Langer Recent Posts

Nuvigil and Provigil Linked to Birth Defects

On Behalf of | May 27, 2020 | Medical Malpractice

Provigil and Nuvigil have been linked to a variety of serious birth defects in babies whose mothers took the drugs during pregnancy.

Provigil and Nuvigal Birth Defect Warnings

In 1998 and 2007 respectfully, the U.S. Food and Drug Administration (FDA) approved the use of Provigil and Nuvigil, which are both manufactured by Cephalon. The purpose of these drugs was is to approve improve wakefulness in adults with narcolepsy, obstructive sleep apnea, and shift work disorder.

Originally, Provigil (modafinil) and Nuvigil (armodafinil) only listed mild side effects including headaches, nausea, nervousness, rhinitis, constipation, back pain, and dry mouth. The FDA confirmed side effects as mild or moderate with the main side effect as headaches. However, The U.S. Department of Justice Drug Enforcement Administration classified the active ingredients, modafinil, and armodafinil, as Schedule IV controlled substances with a potential for dependence and abuse and similar side effects as amphetamines.

Since 1998, millions of Americans have taken Provigil and Nuvigil, including many pregnant women. On June 7, 2019, Teva Pharmaceuticals Ireland issued a warning to health care providers that Provigil (modafinil) taken during pregnancy may cause congenital malformations including:

  • Cleft lips and cleft palates
  • Congenital heart defects
  • Genital birth defects in boys
  • Microcephaly
  • Stevens-Johnson syndrome
  • Psychiatric symptoms

Microcephaly is a serious condition that causes a decreased head and brain size. It causes problems with talking, walking, standing, and sitting, as well as learning disabilities and seizures. Since there is no cure or treatment, children with microcephaly require lifelong care. Stevens-Johnson Syndrome causes a disfiguring skin rash that often results in a life-threatening condition.

In light of Teva Pharmaceuticals’ 2019 health warnings for Provigil and Nuvigil, injures parties across the country have reached out to medical malpractice lawyers to file claims for birth injuries. Between 1999 and November 2019, the FDA received 9,916 combined reports of adverse events for Provigil and Nuvigil (brand names), as well as their generic versions, modafinil, and armodafinil. Out of the 9,916 reports received by the FDA, 4,291 included serious side effects, and 384 included deaths.

To date, Teva Pharmaceuticals has paid $1.2 billion to settle claims by the FTC. In addition, Teva and Barr Pharmaceuticals has agreed to pay $35 million to consumers in 48 states and the District of Columbia as part of a settlement with Attorney Generals from those states.