Provigil/Nuvigil - Consumer Justice Foundation

Provigil/Nuvigil

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Women who take the narcolepsy drugs Provigil or Nuvigil while pregnant may increase their risk of giving birth to a baby with serious birth defects, such as cleft lip, cleft palate, hypospadias, microcephaly or congenital heart malformations.

Pregnant women or women of childbearing age who use Provigil or Nuvigil to combat excessive sleepiness caused by sleep apnea, narcolepsy or shift work sleep disorder may increase their risk of giving birth to babies with serious birth defects. If you were prescribed Provigil or Nuvigil during pregnancy and your child was born with one or more congenital heart defect, cleft lip, cleft palate, hypospadias or microcephaly, you may be able to seek compensation by filing a birth defect lawsuit against Teva Pharmaceuticals-Cephalon. At Consumer Justice Foundation, our consumer advocates are committed to protecting the rights of consumers harmed by defective and dangerous medications, and we can help put you in touch with an experienced drug injury lawyer with experience handling birth defect claims. Contact Consumer Justice Foundation today to find out if you are eligible to file a claim.

Provigil and Nuvigil Alternatives for Narcolepsy, Sleep Apnea

Provigil and Nuvigil have been linked to an increased risk of birth defects in babies exposed to the narcolepsy drugs in utero. Unfortunately, because both Provigil and Nuvigil have the potential to reduce the effectiveness of hormonal contraceptives, like birth control pills, contraceptive patches, NuvaRing and hormonal IUDs, women of childbearing age taking either drug may unexpectedly become pregnant during treatment. If you are pregnant or trying to become pregnant, or if you are a woman of childbearing age, taking Provigil or Nuvigil for narcolepsy, sleep apnea or shift work sleep disorder may not be the best option for you. Instead, you may want to consider the following alternative therapies, which can have positive effects on some disorders or their symptoms, including narcolepsy:

  • Omega-3s
  • 5-HTP
  • Vitamin D
  • Acupuncture
  • Acupressure
  • Massage
  • Diet and lifestyle changes
  • Drinking plenty of water
  • Cutting back on caffeine
  • Getting regular exercise
  • Practicing good sleep hygiene
  • Limiting consumption of stimulating foods and beverages
  • Quitting smoking
  • Getting enough sleep
  • Using herbal remedies

Provigil and Nuvigil Regulatory Warnings

February 2019 – Teva informs Health Canada that the results of the 2018 annual report of the ongoing Provigil/Nuvigil Pregnancy Registry identified “a higher rate of major congenital anomalies, and other adverse reactions, in children exposed to [modafinil] in utero.”

May 2019 – The EMA reports that “Based on limited human experience from a pregnancy registry and spontaneous reporting, modafinil is suspected to cause congenital malformations when administered during pregnancy.” In light of this risk, the EMA warns that “[Modafinil] should not be used during pregnancy.”

June 2019 – Teva, in conjunction with the EMA, issues a Direct Healthcare Professional Communication to healthcare providers, indicating that products containing the active ingredient modafinil may pose unique risks to women who use the medications during pregnancy. According to the notice, “the use of modafinil during pregnancy is suspected to cause congenital malformations.”

June 2019 – Health Canada issues a safety alert warning healthcare providers about the risk of “major fetal congenital malformations, including congenital cardiac anomalies” associated with the use of modafinil during pregnancy.

Provigil and Nuvigil Birth Defect Studies

June 2009 – The Provigil/Nuvigil Pregnancy Registry is established to track pregnant women exposed to at least one dose of Provigil or Nuvigil at least six weeks prior to conception and/or during pregnancy.

2018 – The annual report of the ongoing Provigil/Nuvigil Pregnancy Registry suggests a higher rate of major congenital malformations and other side effects among children born to women who took Provigil or Nuvigil while pregnant.

June 2019 – Reactions Weekly publishes a report indicating that, based on data received from the Nuvigil and Provigil Pregnancy Registry and other spontaneous sources, “reports of major congenital malformations (including congenital heart defects, hypospadias, orofacial clefts) were considered possibly related to use of modafinil.”

Why We Think Teva-Cephalon Should Be Held Liable for Provigil and Nuvigil Birth Defects

Pharmaceutical drug companies are responsible for the safety of their drugs, and when a prescription medication is found to increase the risk of side effects in users or the risk of birth defects in babies born to women who used the medication while pregnant, the drug maker should be held accountable. Lawyers across the country are now investigating claims on behalf of families with children who were allegedly born with Provigil or Nuvigil-induced birth defects. These prospective birth defect lawsuits are expected to accuse Teva and Cephalon of:

  • Designing and manufacturing a defective and dangerous drug
  • Failing to conduct postmarketing research on the safety of Provigil and Nuvigil after the drugs were approved
  • Failing to adequately research the impact of Provigil and Nuvigil on a developing fetus
  • Withholding information about the potential adverse effects of Provigil and Nuvigil use during pregnancy
  • Failing to warn women in the United States about the potential risk of birth defects from Provigil or Nuvigil use in pregnancy

What should you do? If your child was born with a congenital heart defect, orofacial cleft or another serious birth defect, you should contact a lawyer as soon as possible to discuss filing a Provigil or Nuvigil birth defect lawsuit.

Because of the potential for Provigil and Nuvigil use in pregnancy to cause birth defects in exposed babies, health regulatory agencies in other countries have advised pregnant women and women of childbearing age to avoid using products containing modafinil. Unfortunately, there has been no such warning for pregnant women taking Provigil or Nuvigil in the United States, and even if there had been, the warnings come too late for many children who were exposed to Provigil or Nuvigil in utero and have already been born with birth defects like cleft lip, cleft palate, a congenital heart defect or microcephaly. If you took at least one dose of Provigil or Nuvigil while pregnant and your child was born with a serious congenital malformation, you may be entitled to financial compensation for your child’s injuries, medical expenses and other losses. Contact our consumer advocates at Consumer Justice Foundation as soon as possible to discuss your options.

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