JAMA Research Letter Confirms Birth Defects from Provigil and Nuvigil

By Rheingold Giuffra Ruffo & Plotkin LLP

JAMA Research Letter Confirms Birth Defects from Provigil and Nuvigil

We are often asked: If I Take a Stimulant while Pregnant, Will that Affect my Baby’s Health? On January 28, 2020, the much respected Journal of the American Medical Association (JAMA) confirmed that narcolepsy does not cause birth defects. However, when taking a stimulant such as Provigil and Nuvigil causes malformations “Analysis of postmarketing surveillance data detected major malformations among 15% of children exposed to modafinil (Provigil/Nuvigil) during pregnancy compared with 3% in the background population”. Through the research letter, multiple reports of malformations are confirmed and the Doctors strongly advised women contemplating pregnancy should currently avoid or discontinue modafinil.

An important question is brought into play, such as how do stimulants affect unborn children in utero? This question is being asked by mothers due to Provigil and Nuvigil being associated with these birth defects:

  • Cleft lip or palate (orofacial clefts).
  • Hypospadias.
  • Congenital heart defects.
  • Microcephaly

Some animal testing has shown that the use of stimulants is associated with birth defects in children. Also, some studies have shown that newborn children have been diagnosed with microcephaly, an underdeveloped head, and brain. Medical professionals in Europe are concerned that mothers still taking stimulants after 6 weeks may put the fetus at risk. Other defects that have been reported are a cleft lip and lower birth weights. The severity of the defects may correlate with the daily dosage of the stimulant taken.

In previous years other stimulants such as ADHD medications have been going under recent litigation. Selective Serotonin Reuptake Inhibitors (SSRIs) have been under fire for birth defects similar to the Provigil and Nuvigil. With that, it is not uncommon that stimulants can cause birth defects. It is clear that drug companies need to be vigilant when testing these drugs.

If you think you or your child have been affected by birth defects caused by Provigil or Nuvigil, please call the lawyers at Rheingold, Giuffra, Ruffo & Plotkin for a free consultation at (888)260-0473.

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