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

What are Provigil and Nuvigil?

Sleep disorder drugs prescribed to adults suffering from narcolepsy, sleep apnea and shift work sleep disorder that have been linked to birth defects in babies exposed to the medications in utero.

Provigil (modafinil) and Nuvigil (armodafinil) are prescription stimulant medications designed to improve wakefulness in adults struggling with excessive sleepiness due to narcolepsy, sleep apnea or “shift work sleep disorder,” a condition that can affect people who work night shifts or other irregular hours. The medications belong to the CNS stimulants drug class and are meant to stimulate the brain and speed up mental and physical processes, in order to promote wakefulness. Provigil was approved by the FDA in 1998 and Nuvigil was approved in 2007. At the time of their approval, the FDA had designated both Provigil and Nuvigil as pregnancy category C drugs, which means that animal reproduction studies showed an adverse effect on the fetus but there weren’t enough human studies at the time to prove that the drugs posed a risk to exposed babies.

Possible Birth Defects Leading to a Provigil or Nuvigil Lawsuit

According to reports, the rate of major congenital malformations in babies exposed to Provigil or Nuvigil during pregnancy is approximately 15%, compared to the rate of birth defects in the general population, which is 3%. That means expectant mothers who take Provigil or Nuvigil to treat excessive fatigue caused by narcolepsy, sleep apnea or another sleep disorder may be five times more likely to give birth to a baby with congenital malformations than expectant mothers who don’t use the medications. Provigil or Nuvigil use in pregnancy may increase the risk of the following birth defects:

  • Congenital heart defects
  • Cleft lip
  • Cleft palate
  • Microcephaly
  • Miscarriages
  • Fetal growth problems
  • Fetal deaths
  • Hypospadias
  • Atrial septal defects
  • Ventricular septal defects
  • Ebstein anomaly
  • Transposition of the great arteries
  • Pulmonary atresia
  • Tricuspid atresia
  • Total anomalous pulmonary venous return
  • Tetralogy of Fallot
  • Single ventricle
  • Hypoplastic left heart syndrome
  • Coarctation of the aorta
  • Atrioventricular septal defects
  • Double-outlet right ventricle
  • Interrupted aortic arch
  • Truncus arteriosus

Link Between Provigil/Nuvigil and Birth Defects

After developmental toxicity was observed in animal studies, the FDA requested a Provigil/Nuvigil Pregnancy Registry to “characterize the pregnancy and fetal outcomes associated with Nuvigil and Provigil exposure during pregnancy.” In the years since, the potential link between Provigil and Nuvigil and birth defects has become so concerning that health regulatory agencies in other countries have advised that pregnant women avoid using modafinil, that women of childbearing age use effective contraception if they are taking modafinil, and that women of childbearing age continue to use effective contraception for two months after they stop taking modafinil. In June 2019, Teva, in agreement with the European Medicines Agency (EMA), released a statement indicating that, “Based on post-marketing reports from the U.S. Nuvigil and Provigil Pregnancy Registry and other spontaneous sources, the use of modafinil during pregnancy is suspected to cause congenital malformations.” Still, appropriate action has yet to be taken in the United States to warn pregnant women and women of childbearing age about the potential for Provigil or Nuvigil use during pregnancy to cause birth defects in babies.

Provigil and Nuvigil Lawsuits Over Congenital Birth Defects

In March 2019, Teva’s Cephalon unit agreed to a $65.8 million settlement in a Provigil class action lawsuit filed on behalf of five plaintiffs. The lawsuit alleged that Cephalon incentivized other generic drug makers to delay the availability of less expensive generic versions of Provigil in order to safeguard the now-generic medication’s sales. Prior to this class action settlement, in 2015, Teva agreed to pay $1.2 billion to settle similar claims by the Federal Trade Commission that the company illegally blocked generic competition to Provigil. In July 2019, Teva agreed to pay $69 million to the state of California to resolve allegations that the company paid to delay a Provigil generic from entering the market for nearly six years.

The more recent controversy surrounding Provigil, Nuvigil and the potential for the narcolepsy drugs to cause birth defects in babies born to women who used the drugs during pregnancy has led lawyers nationwide to explore civil cases against Teva and Cephalon for serious drug-related injuries. The Provigil/Nuvigil litigation is still in its early stages but Teva and Cephalon could potentially face hundreds of lawsuits claiming that the use of the narcolepsy drugs during pregnancy caused exposed children to be born with cleft palate, cleft lip, congenital heart defects, microcephaly, hypospadias and other serious birth defects.

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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