The consumption of Provigil and/or Nuvigil during pregnancy may be responsible for cleft lips, cleft palate, heart defects, or microcephaly. In June 2019, Teva pharmaceutical Ireland, the European Medicines Agency, and Health Products Regulatory Authority issued warnings regarding these drugs and their potential to cause birth defects. However, the warnings came only after a significant number of pregnant women were prescribed these drugs.
Birth Defects Linked to Provigil and Nuvigil
The rate of birth defects for pregnant women taking either Provigil or Nuvigil was 15%. By comparison, the rate within the overall population is 3%. This is a statistically significant increase in the risk of birth defects similar to Zoloft and highlights the dangers of the drugs and the effect they have on fetal development.
Known defects include cleft lips and palate, facial deformities, heart defects, genital defects, and cranial defects. These injuries can require considerable surgical intervention to correct. These treatments are costly, cause significant pain and suffering to both the infant and parents, and can result in lost wages as parents tend to their child during the recovery process.
Heart and brain defects are the most serious injuries caused by Provigil and Nuvigil. Whether it is microcephaly that results in a smaller brain and cranium, or a heart defect such as pulmonary atresia or ventricular septal defect, damage to these organs can be both life-altering, and life-limiting.
Provigil and Nuvigil may also cause genital birth defects in boys. In particular, hypospadias is the most common and results in a malformed urethra. This can cause difficulty urinating and may result in loss of sexual function at puberty.
No Current US Warning
Despite the actions taken in Europe and by Teva itself, the FDA has not issued a formal warning regarding either Provigil or Nuvigil. While the drug is listed as a Category C drug, the FDA has not issued a formal warning due to a lack of human studies proving the risk to pregnant women.
However, given the mounting evidence, pregnant women and those who are considering becoming pregnant should avoid both drugs as there is a clear link between these drugs and the risk of severe birth defects. Those who have already taken the drug should consult with a medical malpractice lawyer to determine the best way to proceed with both protecting the health of an unborn child and pursuing potential claims.