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The Stimulants Provigil and Nuvigil Causing Birth Defects in Newborns, What Risks are to Come?

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

The Stimulants Provigil and Nuvigil (Generics: Modafinil and Armodafinil) that are often used to combat sleep apnea and narcolepsy are not the subjects to new class action litigation. Investigations are being done in Europe involving birth defects in children whose mothers were taking these stimulant drugs while pregnant. The defects include Microcephaly, Cleft lip or palate (orofacial clefts), Hypospadias, and Congenital heart defects.

Having Discussions with your Doctors about Birth Defect Risks

During product testing, it was shown to have been associated with growth restrictions, spontaneous abortions, and other toxic effects in fetuses. In Europe, the drugs warn to “consult a doctor if pregnant.” Your doctor will help you determine whether the drug is appropriate. This is often called a “risk v. benefit” analysis. Sadly, sometimes patients are more informed than their prescribing doctors. Notably, as of October 2019, there are no birth defect warnings in the United States on drug packaging.

When will you need to stop using these stimulants to not cause birth defects? Studies show that one a mother passes the 28 week mark they need to discontinue the use to prevent decreased birth weight and other defects.

Staying Informed on Birth Defects

On June 20th, 2019 Teva Pharmaceuticals issued a warning to Health Canada and released warnings to Europe, but not the United States.  The pharmaceutical company did not notify the FDA of the recent allegation of the birth defects. Now there is a pregnancy registry set up by both The FDA and Health Canada in order to record the number of birth defects is in connection to this medication. All the while, it is still unknown how this stimulant actually works within the body to help these sleep disorders.

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 & Hellman for a free consultation at (888)260-0473.

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