Provigil & Nuvigil Birth Defect Lawsuits

Experts warn the drugs may be linked to increased risks of birth defects when taken during pregnancy.

Modafinil (brand name Provigil) and armodafinil (brand name Nuvigil) are central nervous system stimulate drugs that are designed to treat exhaustion from narcolepsy, irregular work hours, or sleep apnea.

provigil birth defect lawsuit

Provigil & Nuvigil Birth Defects

Like many stimulants, they are also prescribed to increase attentiveness and energy, reduce sleep and decrease appetite. Provigil has been on the market since 1998, and, together with Nuvigil, rank among the top 250 most-used medications with millions of prescriptions each year.

Unfortunately, reports now show that women who take Provigil or Nuvigil during pregnancy may have 5 times the risk of giving birth to a child with serious birth defects, including:

  • Heart defects
  • Cleft lips or palate
  • Hypospadias (genital defects)
  • Microcephaly (reduced head size)
  • Death.

Health regulators warned about these risks in Europe andCanada in 2019, based on a study conducted in the United States. However, neither the FDA nor the drug’s manufacturer, Teva Pharmaceuticals, have warned patients in the U.S.

Based on the fact Teva has not warned U.S. consumers about the risk of severe birth defects from Provigil and Nuvigil despite knowing the dangers, they may owe substantial compensation to those affected.

Do You Qualify for a Lawsuit?

In 2019, both the European Medicines Agency and Health Canada forced Teva Pharmaceuticals to warn that Provigil may cause birth defects when taken during pregnancy.

Shockingly, these warnings were based in part on results from an ongoing study conducted in the United States since 2009, but patients here haven’t been told of the risks! 

Since Teva Pharmaceuticals may have known of these Provigil and Nuvigil risks for years without warning U.S. patients of the dangers to their newborn babies, they face liability to those affected. 

Lawyers are now helping those who took Provigil or Nuvigil during pregnancy and gave birth to children with certain birth defects. These include:

  • Heart defects
  • Cleft lips or palate
  • Hypospadias (genital defects)
  • Microcephaly (reduced head size)
  • Death from these defects.

Those children inflicted with these conditions may face years of medical care, ongoing therapy and untold pain and suffering. Therefore, the damages from a Provigil or Nuvigil lawsuit can be substantial. 

To speak directly with a lawyer about your case and learn if your child qualifies, contact us today. It costs nothing to investigate your case or file a claim unless you receive an award.

Free Case Review

Provigil & Nuvigil

Birth Defect Lawsuits Timeline

The Journal of the American Medical Association (JAMA) reports on a Danish study showing as much as 15% of children whose mothers took Provigil or Nuvigil during pregnancy may suffer major malformations, compared to the normal rate of 3%.
Teva and subsidiary Cephalon Pharmaceuticals agree to pay $70 million to settle charges that they conspired to prevent generic versions of Provigil and Nuvigil from reaching the market, costing consumers billions of dollars.
Health Canada issues warning that Provigil and Nuvigil may cause birth defects when taken during pregnancy.
Teva Pharmaceuticals agrees to add label warnings to Nuvigil and Provigil sold in Europe advising that the drugs should not be taken during pregnancy, based on studies in the U.S. and Denmark showing higher risks of birth defects.
The European Medicines Agency issues a warning that Provigil may increase the risk of births defects when used during pregnancy, based on the Teva pregnancy registry study in the U.S.
The European Medicines Agency recommends restricting Provigil only for the treatment of narcolepsy due to health concerns.
Due to concerns over animal studies showing pregnancy dangers, Teva opens a pregnancy registry in the U.S. to further study the effects in humans.

Did Teva Know About Provigil & Nuvigil Dangers?

There’s information to suggest Teva Pharmaceuticals may have known about the risk of birth defects from their Provigil and Nuvigil drugs for more than ten years before they first warned patients in Europe of the dangers.

Even more troubling is that they still haven’t warned any patients in the United States of the danger to their children, even though part of the data on which the European warnings were based was collected from a study going on in the U.S. since 2009. 

This is undoubtedly one of the clearest cases of disregard for child safety by a pharmaceutical company that we’ve ever seen at DrugNews. 

As early as 1998 and 2007 when the FDA approved Provigil and Nuvigil, they notified Teva that the drugs showed possible birth defects in animal studies, and would need to be tested more on humans. 

In 2009, Teva Pharmaceuticals established a pregnancy registry test to gather more data on the effects Provigil and Nuvigil might have on babies when taken during pregnancy. To date, the company has gathered data on more than 1 million births both here and in Europe. 

Now, Teva has alerted some regulators that the Nuvigil and Provigil Pregnancy Registry studies are showing early findings of a 5-fold rise in birth defect risks. However, they haven’t yet warned women in the U.S. not to take these drugs during pregnancy.

Provigil & Nuvigil Side Effects

Like many other popular prescription medications, the manufacturer’s list of Provigil and Nuvigil side effects includes such generic and common ailments that patients might barely take notice. 

These include relatively standard drug side effects like:

  • Headaches
  • Nausea
  • Weight loss
  • Darkened stools
  • Blurred vision
  • Chest pain
  • Fever or chills
  • Dizziness
  • Confusion
  • Increased thirst
  • Depression
  • Shortness of breath
  • Sore throat
  • Facial tremors.

What’s missing from this list, however, at least for the tens of thousands of women taking Provigil or Nuvigil in the United States, is that their child may have as much as a 15% chance of being born with birth defects if they take it during pregnancy.  

Some of these include:

  • Congenital heart defects
  • Cleft lips or cleft palate
  • Genital defects
  • Reduced head size
  • Death.

DrugNews is urging the FDA to force Teva to add these serious side effects to the labels of both Provigil and Nuvigil, and anyone affected by the failure of them to do so to speak with a lawyer about their legal rights.

Free Case Review

Choosing a Provigil Lawyer

If your child was born with any birth defects after you took Provigil or Nuvigil, it is important to have your case examined by a legal expert to see if your medication was a factor.  

Our qualified birth defect lawyers will fully investigate your case, reviewing medical records, pharmacy records and recent studies that your doctor may not normally discuss.  

Most states allow you to file a lawsuit until your child reaches the age of 18. However, it is important to start the process as early as possible to make sure your lawyer can secure the necessary medical records and prepare your case before it is too late. 

DrugNews works only with attorneys and law firms that have successfully handled thousands of lawsuits involving birth injuries from prescription drugs. And, we make it easy to speak directly with a lawyer or patient advocate today, so that you’ll quickly be able to decide if you want to proceed. 

We make it easy to get help, find out if you qualify, and quickly file a claim. Our service is offered at no cost to you, and you won’t pay anything to your attorney unless you receive an award. Also, our qualified lawyers can handle most aspects of your case without you ever having to leave your home. 

For more information, or to learn about your options - call, chat or email us today.

Do you have a case?

Speak with a lawyer who specializes in the birth defect litigation.

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