Americans suffering from sleep disorders are sometimes prescribed central nervous system (CNS) stimulants like Provigil and Nuvigil to make sleep disorders more manageable. However, clinical reports have found an increased risk of birth defects in women taking these medications. James F. Humphreys & Associates, L.C. has years of experience litigating causes of serious birth injuries and defects and will review your claim for compensation.
About Provigil and Nuvigil
Provigil (modafinil) and Nuvigil (armodanifil) are CNS stimulants used to treat sleep disorders such as sleep apnea, narcolepsy and sleep loss related to working night shifts or other irregular hours (“shift work disorder”). Although these medications do not cure sleep disorders, they can provide temporary relief by activating brain centers responsible for wakefulness.
When the FDA approved Provigil in 1998 and Nuvigil in 2007, it required the manufacturer, Teva Pharmaceuticals, Ltd., to conduct additional research because animal studies suggested pregnancy related risks. In 2009, Teva established a Pregnancy Registry to collect data on birth defects among women taking these drugs, a registry intended to run until 2027.
Interim data from the 2018 annual registry report indicated a five-fold increase in serious birth defects among women taking these drugs, 15% compared to 3% among the general population. In 2019, Teva notified the European Medicines Agency (EMA) and Health Canada of birth defects associated with its products. The EMA required labeling changes and on June 7, 2019, Teva issued a Direct Communication to Healthcare Professionals, but it did not warn consumers in the United States.
Birth defects associated with Provigil and Nuvigil include:
- Microcephaly (an underdevelopment of the brain and head which leads to seizures, learning disabilities, and problems with motor development)
- Cleft lip or palate (an opening in the lip or upper roof of the mouth which causes difficulties eating and talking and can also lead to hearing problems, teeth problems and ear infections)
- Hypospadias (a genital birth defect in boys involving the opening of the urethra which may cause difficult urination and sexual dysfunction)
- Congenital heart defects
- Death related to these birth defects
Cleft lip or palate, hypospadias and congenital heart defects may require surgery, but there is no cure or treatment for microcephaly.
If you believe that Provigil or Nuvigil has resulted in birth defects in your child or a loved one, contact James F. Humphreys & Associates, L.C. for a free consultation.
Toll Free: +1 (800) 763-4500
Email: [email protected]
Although there have been reported injuries with this drug, the FDA has not withdrawn its approval at this time. Do not stop taking a prescribed medication without first consulting with your doctor. Discontinuing a prescribed medication without your doctor’s advice can result in injury or death.