Provigil and Nuvigil Linked to Birth Defects

Reports suggest using Provigil or Nuvigil during pregnancy could potentially result in birth defects. Healthcare professionals in Europe and Canada were notified that these drugs should not be used by pregnant women, but the warning is too late for many children who have already been born with Provigil or Nuvigil-induced birth defects.(1,2)
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Provigil and Nuvigil Lawsuits

Weitz & Luxenberg is accepting cases for filing lawsuits in which children were born with congenital defects because they were exposed to Provigil (modafinil) or Nuvigil (armodafinil) in utero.

If you or your child was born with a birth defect linked to taking Provigil or Nuvigil while pregnant, we encourage you to contact us.

Was your child born with birth defects after you used Provigil or Nuvigil during pregnancy? Contact us now for a free evaluation.

(800) 476-6070

We can provide you with guidance and help you consider your legal options. You may be eligible to seek compensation for your or your child’s medical expenses, pain and suffering, and other related injuries.

What Are Provigil and Nuvigil?

Provigil (modafinil) and Nuvigil (armodafinil) are indicated to improve wakefulness in adults who experience excessive sleepiness that may accompany obstructive sleep apnea, narcolepsy, or “shift work disorder.” (3) (4)

Provigil was released on the U.S. market in December 1998, and Nuvigil was in June 2007.

Significant Birth Defects Linked to Provigil and Nuvigil

Teva, the manufacturer of Nuvigil and Provigil, has announced several major birth defects are possible if a woman takes Provigil or Nuvigil during pregnancy. Structural and functional birth defects may occur. (5)

Birth defects potentially linked to Provigil or Nuvigil include, but are not limited to: (6) (7)

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

Though not specifically mentioned by name in Teva’s or regulatory agencies’ notifications regarding Provigil or Nuvigil, these are some specific types of congenital heart defects:

  • Atrial septal defects.
  • Atrioventricular septal defects.
  • Coarctation of the aorta.
  • Double-outlet right ventricle.
  • D-transposition of the great arteries.
  • Ebstein anomaly.
  • Hypoplastic left heart syndrome.
  • Interrupted aortic arch.
  • Pulmonary atresia.
  • Single ventricle.
  • Tetralogy of Fallot.
  • Total anomalous pulmonary venous return.
  • Tricuspid atresia.
  • Truncus arteriosus.
  • Ventricular septal defects.

Regulatory Warnings for Pregnant Women

In mid-2019, multiple government health regulatory agencies have issued warnings regarding Provigil and Nuvigil and the potential for the ingestion of these drugs to result in birth defects when taken by pregnant women.

European Medicines Agency (EMA)

Adverse event reporting and a pregnancy registry have indicated Provigil and Nuvigil may result in reproductive toxicity in humans. Studies in animals have demonstrated reproductive toxicity. The EMA mandated label changes to state these drugs should not be used during pregnancy and women of childbearing potential must use effective contraception. (8) (9)

Government of Canada, Health Canada

Modafinil, the generic version of Provigil, “has been associated with cases of major fetal congenital malformations, including congenital cardiac anomalies” if taken during pregnancy. The Nuvigil/Provigil Pregnancy Registry reported frequency of major congenital anomalies to be 17.3%, compared to 3% in the general population. The government has warned that modafinil “is now contraindicated in women who are pregnant or may become pregnant.” (10)

Pregnancy Registry Documents Birth Defects

The main objective of the Nuvigil and Provigil Pregnancy Registry is to “characterize the pregnancy and fetal outcomes” resulting from exposure to Nuvigil and Provigil during pregnancy. (11)

In February 2019, Teva notified Health Canada the Nuvigil/Provigil Pregnancy Registry annual report for 2018 had cases of birth defects, including: (12)

  • Major congenital anomalies occurring at a frequency far higher than the general population, 17.3% vs. 3%.
  • Spontaneous abortion.

Based on data collected from the 2018 Annual Registry report, “the rate of major congenital malformations was approximately 15% compared to 3%… in the general population.” (13) (14)

Because of this, health regulatory agencies have warned women who are pregnant should not use products containing modafinil. In addition, women who could become pregnant should not use products containing modafinil unless they are using effective contraception. (15)

Nuvigil and Provigil Pregnancy Registry Ongoing

The Nuvigil/Provigil Pregnancy Registry is ongoing and is expected to conclude by the end of 2026. The registry is accepting participation from “any woman who is pregnant, and was exposed to at least one dose of armodafinil or modafinil within 6 weeks prior to conception and/or during pregnancy.” (16)

The overall objective is to “characterize the pregnancy, fetal and newborn outcomes” of exposure to Nuvigil or Provigil immediately before or during pregnancy.

The study is focusing on the following possible complications: (17)

  • Major congenital defects.
  • Alterations in fetal growth.
  • Congenital anomalies.
  • Fetal deaths.
  • Miscarriages.
  • Live births.
  • Elective termination of pregnancy.

TEVA Pharmaceuticals Issues Warning to Europe and Canada

On June 7, 2019, TEVA Pharmaceutical Industries, in agreement with the EMA, issued a Direct Healthcare Professional Communication to health care professionals regarding modafinil, sold under the names Nuvigil and Provigil, among others. (18)

Health care providers were advised that products containing modafinil may pose unique risks to women who take them during pregnancy. Data suggest increased risk of major congenital malformations. (19)

Though notified by Health Canada of similar data shortly afterward, Teva has yet to issue a similar warning to consumers in the United States.

Health care providers and women who are pregnant or plan on becoming pregnant should be aware, per Teva’s notification to healthcare professionals:(20)

  • The use of modafinil during pregnancy has been linked to an increased risk of birth defects.
  • Pregnant women should not use modafinil.
  • All female patients of childbearing potential should be informed of the potential risk of birth defects linked to modafinil-containing products during pregnancy.
  • Modafinil may diminish the effectiveness of oral contraception; therefore, women should use other or accompanying methods of birth control.
  • Women who have the potential to get pregnant must use effective contraception if they are taking modafinil.
  • Women need to use effective contraception 2 months after they stop taking modafinil.
W&L Attorney Handling Provigil and Nuvigil Litigation
Ellen Relkin, attorney at Weitz & Luxenberg

Ms. Relkin, whose practice focuses on medical device and pharmaceutical product liability, as well as toxic tort matters, has represented thousands of plaintiffs injured by defective medical products with a recent focus on the generation…

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Weitz & Luxenberg Wins Cases

Weitz & Luxenberg has represented thousands of people harmed by defective drugs. Our attorneys have played a key role in helping secure billions of dollars in compensation for our clients.

Weitz & Luxenberg is a law firm with a dedicated Drug and Medical Devices Litigation Unit. Our attorneys have decades of experience handling complicated litigation involving defective drugs and devices.

*Past performance is no guarantee of future results. The Actos verdict was reduced to approximately $38 million by the trial court on October 27, 2014. The settlements in which Weitz & Luxenberg played leadership roles included patients not represented by W&L.

  1. Teva Pharmaceuticals Ireland. (2019, June 7). Direct Healthcare Professional Communication (DHPC). Modafinil: potential risk of congenital malformations when administered during pregnancy. Retrieved from http://www.hpra.ie/docs/default-source/default-document-library/important-safety-information---modafinil99170c2697826eee9b55ff00008c97d0.pdf?
  2. Government of Canada, Health Canada. (2019, June 20).ALERTEC (modafinil) and the Risk of Congenital Anomalies. Retrieved from http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/70201a-eng.php
  3. U.S. Food & Drug Administration. (2015, January). Prescribing Information. Provigil. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020717s037s038lbl.pdf
  4. U.S. Food & Drug Administration. (2017, February). Prescribing Information. Nuvigil. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021875s023lbl.pdf
  5. Teva Pharmaceuticals Ireland. (2019, June 7). Direct Healthcare Professional Communication (DHPC). Modafinil: potential risk of congenital malformations when administered during pregnancy. Retrieved from http://www.hpra.ie/docs/default-source/default-document-library/important-safety-information---modafinil99170c2697826eee9b55ff00008c97d0.pdf?
  6. Ibid.
  7. Government of Canada, Health Canada. (2019, June 20). Recalls and safety alerts. ALERTEC (modafinil) and the Risk of Congenital Anomalies. Retrieved from https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/70201a-eng.php
  8. European Medicines Agency. (2019, May 6). PRAC recommendations on signals. Retrieved from https://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-8-11-april-2019-prac-meeting_en.pdf
  9. Teva Pharmaceuticals Ireland. (2019, June 7). Direct Healthcare Professional Communication (DHPC). Modafinil: potential risk of congenital malformations when administered during pregnancy. Retrieved from http://www.hpra.ie/docs/default-source/default-document-library/important-safety-information---modafinil99170c2697826eee9b55ff00008c97d0.pdf
  10. Government of Canada, Health Canada. (2019, June 20). Recalls and safety alerts. ALERTEC (modafinil) and the Risk of Congenital Anomalies. Retrieved from https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/70201a-eng.php
  11. National Institutes of Health, U.S. National Library of Medicine. ClinicalTrials.gov. (2013, February 15). The Nuvigil and Provigil Pregnancy Registry. Retrieved from https://clinicaltrials.gov/ct2/show/NCT01792583
  12. Government of Canada, Health Canada. (2019, June 20). Recalls and safety alerts. ALERTEC (modafinil) and the Risk of Congenital Anomalies. Retrieved from https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/70201a-eng.php
  13. Teva Pharmaceuticals Ireland. (2019, June 7). Direct Healthcare Professional Communication (DHPC). Modafinil: potential risk of congenital malformations when administered during pregnancy. Retrieved from http://www.hpra.ie/docs/default-source/default-document-library/important-safety-information---modafinil99170c2697826eee9b55ff00008c97d0.pdf?
  14. Ibid.
  15. Government of Canada, Health Canada. (2019, June 20). Recalls and safety alerts. ALERTEC (modafinil) and the Risk of Congenital Anomalies. Retrieved from https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/70201a-eng.php
  16. National Institutes of Health, U.S. National Library of Medicine. ClinicalTrials.gov. (2013, February 15). The Nuvigil and Provigil Pregnancy Registry. Retrieved from https://clinicaltrials.gov/ct2/show/NCT01792583
  17. Ibid.
  18. Teva Pharmaceuticals Ireland. (2019, June 7). Direct Healthcare Professional Communication (DHPC). Modafinil: potential risk of congenital malformations when administered during pregnancy. Retrieved from http://www.hpra.ie/docs/default-source/default-document-library/important-safety-information---modafinil99170c2697826eee9b55ff00008c97d0.pdf?
  19. Ibid.
  20. Ibid.

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