Updated May 17, 2022

Zofran Connected to Birth Defects

Wilson Kehoe Winingham is currently reviewing drug injury cases for mothers who took Zofran during the first trimester of pregnancy and have a child with a confirmed birth injury, such as heart defects or a cleft lip or palate. Call our Indianapolis Drug Injury Attorneys at 317.920.6400 or fill out an online contact form for a free, no-obligation case evaluation

How Zofran Works

Zofran (Ondansetron) is a prescription medication used to treat nausea and vomiting associated with cancer chemotherapy and radiation. It is also prescribed as a means to prevent nausea and vomiting after surgery. Zofran is in a class of medications called serotonin 5-HT3 receptor antagonists. Zofran works by blocking the secretion of serotonin—a natural neurotransmitter—in certain parts of the brain that may cause nausea and vomiting.

Zofran is manufactured by U.K.-based pharmaceutical company GlaxoSmithKline and was first approved by the Food and Drug Administration (FDA) in January 1999. However, despite the fact that Zofran and its generic were only approved for the treatment of nausea and vomiting after chemotherapy, radiation, or surgery, physicians are using Zofran as an off-label treatment option for morning sickness (nausea and vomiting during pregnancy, or NVP) in pregnant women.

GlaxoSmithKline soon acknowledged the potential for a brand new market and, without FDA approval, began marketing Zofran to physicians and expectant mothers as a way to treat NVP. Roughly 1 million pregnant women are prescribed Zofran every year.

The FDA has classified Zofran as a “Pregnancy Category B” drug, meaning that it has not been the subject of any well-controlled studies to determine the effects Zofran may have during pregnancy. However, the FDA has approved “Pregnancy Category A” drug called Diclegis to safely treat morning sickness in pregnant women. All “Pregnancy Category A” drugs have been adequately tested and deemed safe for use during pregnancy.

Serotonin Syndrome Linked to Zofran Use

In March 2013, the FDA confirmed in an adverse events report that the use of Zofran may be linked to a condition called serotonin syndrome. Serotonin syndrome is caused by a heavy increase of serotonin and can result in excessive nerve activity in the brain. Symptoms of serotonin syndrome can develop within hours of taking Zofran, the most common including the following:

  • High fever
  • Irregular heartbeat
  • Seizures
  • Unconsciousness

In severe cases, death can occur.

Zofran and Its Connection to Birth Defects

The use of Zofran during pregnancy has been linked to birth defects.

Heart Defects

A Zofran birth defect study published in Reproductive Toxicology consisted of an analysis 1.5 million births. Roughly 1,349 of those babies were born between 1998 and 2012 and had mothers took Zofran during the early stages of their pregnancies. After careful examination, it was concluded that Zofran should not be prescribed as an off-label treatment option for morning sickness, as the results showed that taking Zofran during the first trimester/early pregnancy increased the risk for heart defects in babies.

While these findings were powerful, researchers still urged for further studies to sufficiently determine an increased risk for Zofran heart defects and to determine if any more cardiac defects were possible.

Cleft Lip and Palate in Infants

Boston University’s Slone Epidemiological Center and Harvard University examined the use of ondansetron in the first trimester of pregnancy and found that babies born to mothers who took the medication for morning sickness were more than 2.37 times more likely to have a cleft palate.

Why Parents Are Filing Zofran Lawsuits

Victims across the country are filing drug injury lawsuits against Zofran’s manufacturer for allegedly:

  • Illegally marketing and advertising Zofran to pregnant women as a treatment option for conditions other than those originally approved by the FDA
  • Failing to inform the public and medical community of risks relating to Zofran use in pregnant women
  • Paying kickbacks to physicians for prescribing Zofran to pregnant women

In 2012, GlaxoSmithKline paid $3 billion to the United States Department of Justice to settle the above criminal and civil penalties.

Zofran Lawsuit Eligibility

If you were prescribed Zofran during your first trimester of pregnancy and have a child with a heart defect or cleft palate, you may be entitled to compensation for any or all of the following:

  • Medical expenses
  • Treatment costs for your child’s birth defects
  • Pain and suffering

Additionally, if you are a mother who experienced adverse side effects of Zofran, such as serotonin syndrome, you may also be entitled to compensation.

Contact a Drug Injury Attorney Today

While there are no guarantees that a court will rule in your favor, the costs associated with multiple surgeries, lifesaving procedures, and long-term therapies will undeniably add up over time. Not to mention the fact that at no point in time should you have ever been misguided through illegal advertising on behalf of GlaxoSmithKline. It’s your turn to fight back and hold GlaxoSmithKline accountable.

If your child has suffered birth defects as a result of you taking Zofran during your first trimester, you are urged to contact the Indianapolis Drug Injury Attorneys of Wilson Kehoe Winingham. The lawyers at WKW can help you get the compensation you deserve. Call 317.920.6400 or fill out an online contact form for a free, no-obligation case evaluation.

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