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Birth Defects Associated With Medications To Treat Sleep Disorders

By Burg Simpson

October 20, 2020   Ohio Dangerous Drugs and Medical Devices, Ohio Legal Updates

A recent article published in the Journal of the American Medical Association (JAMA) reports findings from a pregnancy registry linking birth defects with the use of prescription drugs Provigil and Nuvigil. Provigil (generic Modafinil) and Nuvigil (generic Armodafinil) are approved by the FDA to treat excessive sleepiness in adults suffering from narcolepsy, sleep apnea, and shift work disorder.

A pregnancy registry was established in February 2010 to evaluate fetal outcomes in women taking these drugs during pregnancy. According to the JAMA article, data collected from 2010 through 2019 establishes a rate of major congenital malformations in live births at 13 percent, compared to a prevalence rate of 3 percent in the general population. The most common reported congenital malformations were torticollis (twisting of the neck), hypospadias (an abnormality of the penis), and heart defects. The results demonstrate there is a potential fourfold increased risk of major congenital malformations following in utero exposure to Provigil and Nuvigil compared to the risk of birth defects in the general population. Previous data suggests the underlying condition of narcolepsy does not itself increase the risk of birth defects.

Federal health authorities in Europe and Canada issued warnings in June 2019 to inform health care providers that use of Provigil and Nuvigil is suspected to cause birth defects. They instructed prescribers to make sure women of childbearing years use effective contraception while taking Provigil or Nuvigil. Despite the actions taken in Europe and Canada, the prescribing labels for Provigil and Nuvigil in the U.S. have not been updated with important information obtained from the pregnancy registry about the increased risk of birth defects.

If you or a loved one suffered birth defects you believe were caused by Provigil or Nuvigil, contact the nationally recognized product liability attorneys in Burg Simpson’s Cincinnati, Ohio office today. They can be reached by phone at (513) 852-5600 or through their website.

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