People are filing Provigil and Nuvigil lawsuits against manufacturers for congenital disorders
Consumption of Provigil or Nuvigil during pregnancy could result in birth defects. Many women were not warned soon enough and this has caused many children to be born with Provigil or Nuvigil realted birth defects.
Provigil and Nuvigil shown to cause birth defects, patients seek compensation
Taking sleep disorder drugs Provigil (modafinil) and Nuvigil (armodafinil) during pregnancy has been linked to birth defects.
Mothers who took the drugs during pregnancy are now beginning to file lawsuits against the manufacturers of Provigil (Cephalon) and Nuvigil (Teva), demanding compensation for the damage their products caused.
What are Provigil and Nuvigil?
Provigil and Nuvigil are brands of the stimulant drugs modafinil and armodafinil, commonly used to treat sleep disorders but now increasingly taken to improve cognitive function. Doctors prescribe the drug for patients with sleep apnea or narcolepsy, though little is understood about how the drugs’ wakefulness mechanisms operate. Provigil and Nuvigil are also part of a relatively new class of nootropics, or cognitive enhancement drugs, that many people use “off-label” to improve concentration, reaction time, vigilance and motivation.
What are the risks of Provigil and Nuvigil for pregnant women?
In 2019, Teva warned the European Medicines Agency about the possible links between taking modafinil while pregnant and birth defects, including heart defects, cleft lip and palate, microcephaly and hypospadias.
According to Teva, an observational study in the US showed that children of women who took modafinil are five times more likely to display birth defects than a control. The study looked at women who took modafinil or armodafinil up to six weeks prior to conception or during pregnancy. Based on the study’s findings, the European Medicines Agency announced that women should no longer take modafinil or armodafinil during pregnancy, and should use effective contraception methods for at least two months after ceasing treatment with either drug.
Researchers have also used Danish pregnancy records to show that prenatal exposure to modafinil increases the chance of congenital defects from 3.9% to 12%.
Congenital heart defects that may be linked to Provigil and Nuvigil include atrial defects, atresias, ebstein anomaly and septal and ventricle defects.
The European Medicines Agency and Health Canada both issued warnings about the links between modafinil and congenital defects in 2019, but the US Food and Drug Administration has yet to do the same. Teva and other manufacturers of modafinil and armodafinil are reportedly carrying out longitudinal studies on the risks of their products but may not have results until 2027.
Brands of Modafinil and Armodafinil
Modafil MD (modafinil)
Patients whose children developed birth defects file Provigil and Nuvigil lawsuits and seek compensation
As drug companies and researchers confirm the links between modafinil and birth defects, some consumers are seeking compensation from the manufacturers of Provigil and Nuvigil. These lawsuits are ongoing and allege that the drug companies bear responsibility for exposing patients to the risks associated with Provigil and Nuvigil.
Women who took or are now taking Provigil or Nuvigil while pregnant may be eligible to file lawsuits against these drug companies for damages. Whether they took modafinil for a sleep disorder or as a cognitive enhancer, these women and their families are turning to personal injury lawyers to address their cases.
There is currently no class action lawsuits for pregnant women or families of children who developed birth defects after taking Provigil or Nuvigil. There have, however, been claims involving settlements worth over $1.2 billion against Teva and other drug companies for paying generic drug manufacturers to delay production of generic versions of Provigil.
The number of cases against Teva, Cephalon and other modafinil and armodafinil manufacturers is growing and law firms working on the issue are still determining the amount of compensation to which patients may be entitled. As Teva has already come forward about the risks associated with their products, the legal process is likely to move quickly in the US as lawyers add to the number of patients seeking damages.