Many of the estimated 85 percent of pregnant women who experience some form of morning sickness will use an anti-nausea medication.

While some drugs provide relief, others can pose risks in vitro. Zofran birth defects may include cleft lip, craniosynostosis, and congenital malformations. 

The Truth

Studies + Science

Regulation Recap

The Next Steps
Zofran, a potent anti-nausea drug used to treat cancer patients, is regularly misprescribed to pregnant women.Zofran exposure increases the risk of congenital and facial birth defects.The drug manufacturer GlaxoSmithKline pleaded guilty to illegally promoting Zofran for unintended uses.For families injured by Zofran, help is out there.

The Truth

Anti-Nausea Drug Zofran Can Cause Birth Defects, Cleft Lip, Heart Defects

Zofran is an anti-nausea drug used to treat cancer. The drug is a 5-HT3 receptor antagonist that acts on serotonin receptors to block negative symptoms. It’s also known by its generic form ondansetron.

Manufactured by GlaxoSmithKline, Zofran is prescribed for nausea and vomiting caused by cancer medication or surgery, such as chemotherapy or radiation. It has not been designated for any other causes of nausea, including morning sickness. However, the manufacturer GlaxoSmithKline unlawfully encouraged doctors to prescribe it for other uses.

Zofran, often used to treat extreme morning sickness, can be a great remedy for some women. However, Zofran birth defects can be severe and debilitating. Zofran birth defects include cleft lips, cleft palates, clubfeet, craniosynostosis, congenital heart issues, and lung problems in newborns.

Zofran’s Uses

When having a child, women often expect to deal with morning sickness. About 70 to 80 percent of women experience mild morning sickness during pregnancy.

But there’s another kind of morning sickness that it is not often publicized. Hyperemesis gravidarum is an extreme form of morning sickness that causes severe nausea and vomiting. If untreated, severe morning sickness can cause dehydration, poor weight gain, and social or psychological problems. Women may not gain sufficient weight during pregnancy, which is a threat to the development of the fetus.

Symptoms of Morning Sickness

  • Nausea that is sometimes accompanied by vomiting
  • Nausea that subsides after 12 weeks
  • Vomiting that does not cause severe dehydration

Symptoms of Hyperemesis Gravidarum

  • Nausea that does not subside
  • Nausea accompanied by severe vomiting
  • Vomiting that causes severe dehydration and does not allow you to keep any food down
  • Vomiting more than three or four times per day
  • Becoming dehydrated
  • Feeling light-headed or dizzy
  • Losing more than 10 lbs. or five percent of your body weight due to vomiting
  • Constant nausea

Zofran Side Effects

Side effects of Zofran include, but are not limited to:

  • Blurred vision or temporary vision loss
  • Impaired thinking
  • Irregular heart rate
  • Jaundice
  • Difficulty breathing
  • Anxiety or agitation
  • Shivering
  • Unusual urination patterns
  • Diarrhea or constipation
  • Drowsiness or tiredness

Studies + Science

The drug’s active ingredient is ondansetron, which is an allergen for some patients. Researchers believe that Zofran may harm a nursing baby through a woman’s breast milk. Pregnant women should not use Zofran while breastfeeding.

In December 2014, Dr. Gideon Koren published a study in the American Journal of Obstetrics and Gynecology on the dangers of using Zofran while pregnant. The study included 900,000 Danish women and found that the use of Zofran led to a 30 percent increased risk of major congenital malformations. The popularity of the drug, which is due to the manufacturer’s advertising techniques, becomes a frightening truth for babies born with birth defects.

Zofran Birth Defects

Studies occurring between 2016 and 2019 have linked pregnant women who consume ondansetron during pregnancy to two major birth defects in infants. First, the use of Zofran is strongly linked to infants being born with cleft lip by the National Institute of Health (NIH), studies cited by the Center for Disease Control, and scientific journals such as MedPage Today.

The second, more serious potential birth defects are renal agenesis and renal dysgenesis. In renal agenesis, an infant is born without one of their kidneys; in bilateral renal agenesis, an infant is born without either kidney.

Similarly, renal dysgenesis occurs when the kidneys are malformed at birth and can neither filter the blood nor produce urine to dispose of impurities in the blood. While no study has yet causally linked Zofran to these conditions, there is an array of scientific data to suggest that there is a tangible connection between Zofran use and these birth defects.

“The use of ondansetron for nausea and vomiting in pregnancy has increased from 50,000 monthly prescriptions in 2008 to 110,000 at the end of 2013, despite unresolved issues regarding fetal safety and Food and Drug Administration warnings about serious dysrhythmias,” according to the study.

Regulation Recap

The FDA approved Zofran in 1991 to treat cancer patients suffering from nausea. Since 1992, doctors prescribed Zofran to treat morning sickness—only a year after the agency approved it for use in cancer patients. The pharmaceutical manufacturer GlaxoSmithKline engaged in the unlawful off-label promotion of the drug despite the fact that conflicting scientific studies question the safety of Zofran for other uses.

The FDA released a safety communication about June 29, 2012, which said: “32 mg, single IV dose should be avoided due to the risk of a specific type of irregular heart rhythm called QT interval prolongation, which can lead to Torsades de Pointes, an abnormal, potentially fatal heart rhythm.”

In 2012, the company pleaded to criminal charges for off-label promotion of Zofran in a settlement with the FDA. GlaxoSmithKline paid $3 billion to resolve charges of unlawful promotion and failure to report safety data in the largest health care fraud settlement in U.S. history. The company has also paid about $1 billion to settle civil lawsuits, but many are still pending.

In 2015, a Minnesota mother filed the first civil Zofran lawsuit for the congenital heart defects that occurred in her two daughters after their birth. In October of the same year, 12 more Zofran lawsuits were delegated to the United States District Courts of Massachusetts.

In 2016, a judge rejected a motion by GlaxoSmithKline to dismiss over 200 pending cases. Two years later, GlaxoSmithKline successfully motioned to dismiss generic lawsuits past a certain date, but further motions reinstated many of those cases.

As of February 2019, legal actions against GlaxoSmithKline have escalated to a multi-district litigation. The discovery phase of more than 500 cases is moving forward and will presumably lead to a trial to bring GlaxoSmithKline to justice for their role in targeting pregnant women without informing them of the potential harms of Zofran and ondansetron.

The Next Steps

Caring for a child with Zofran birth defects can be difficult. Mounting medical costs and endless time spent finding the right providers can affect the ability to generate enough income to provide support.

The story is still unfolding. We’re here to help.

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