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.
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:
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.
Birth Defect Lawsuits Timeline
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.
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.