Zofran & Brain Defects

A series of major epidemiological studies have concluded that the anti-nausea drug Zofran may be associated with an increased risk of major birth defects. Researchers have found elevated rates of:

  • cleft palate,
  • congenital heart defects and
  • kidney malformations

among babies born to mothers who were prescribed Zofran as an “off label” treatment for morning sickness during the first trimester.

Zofran Birth Defects: Hydrocephalus & Other Brain Abnormalities

American families have now begun to file Zofran birth defect lawsuits. Numerous major birth defects have been named in these legal claims, including at least one brain defect.

In case number 5:15-34, filed in the United States District Court for the Eastern District of Texas, Texarkana Division, a mother claims that Zofran exposure during early pregnancy caused her child to be born with “fluid on the brain.”

What Is Hydrocephalus?

Commonly known in the medical community as hydrocephalus, “fluid on the brain” is a condition in which the brain is surrounded by too much cerebrospinal fluid (CSF).

Estimates place the incidence of congenital hydrocephalus around 1 out of every 500 babies.

At healthy levels, CSF acts as a necessary cushion between the delicate brain and the hard skull. CSF flows slowly through four channels, or “ventricles,” bathing brain tissue in a solution of nutrients and oxygen. But at high volumes, excessive CSF can actually widen ventricles, placing pressure on brain tissue.

Immediate symptoms of congenital hydrocephalus in newborns include:

  • abnormally large head size
  • nausea and vomiting
  • excessive fatigue
  • restlessness
  • seizures

Over time, as the pressure around their brains continues to build, children can begin to suffer from severe headaches, visual disturbances and an inability to control bladder activity.

In her complaint, the plaintiff in case 5:15-34 notes that her child suffers from “multiple developmental delays hindering his growth.” According to the National Institute of Neurological Disorders & Stroke, a gradual “slowing or [abrupt] loss of developmental progress” is a potential symptom of hydrocephalus. When untreated, permanent brain damage is likely.

The standard treatment for congenital hydrocephalus is invasive surgery, a procedure in which surgeons attempt to place a drain (“shunt”) that can allow CFS to flow properly. Plaintiff says that her family “anticipates” multiple surgical procedures to correct her son’s congenital abnormalities.

Hydrocephalus is often considered a symptom of other birth defects, because many congenital abnormalities can cause the flow of cerebrospinal fluid to be blocked. And unlike the brain defects that we’ll describe below, hydrocephalus can develop at any time during a pregnancy.

Neural Tube Defects

Unlike hydrocephalus, most birth defects that involve the brain develop during the first trimester of pregnancy, generally in the first month or six weeks of fetal growth.

At this early stage, all the structures that we’ll come to recognize as a child’s central nervous system, including the brain and spinal cord, are no more than a groove or slight depression in a fetus’ back. Over time, special cells fold over and meet, creating a closed neural tube. Notably, the top of the tube will ultimately become a baby’s skull.

But when this tube fails to form properly, and remains open in places, babies can be born with neural tube defects.

The Centers for Disease Control & Prevention reports that “3,000 [US] pregnancies are affected by neural tube defects every year.”


Possibly the most severe neural tube defect, anencephaly occurs when babies are born with large portions of the brain, skull and scalp missing. Anencephaly is always fatal, and babies with the condition usually die within hours of delivery.

According to March of Dimes, around 1,000 babies are born with anencephaly in America every year.


Like anencephaly, encephalocele is the result of the neural tube’s upper end failing to close properly. In this condition, portions of a baby’s skull failed to join together. As a result, a sac that contains brain tissue and other membranes is allowed to protrude outside of the head.

The CDC estimates that 375 babies are born with encephalocele in the US each year. Some relatively minor cases, especially when the affected area lies between a child’s forehead and nose, go undiagnosed.

Spina Bifida

While not technically a brain defect, spina bifida is the most common neural tube defect in the US, affecting around 1,500 babies every year.

Myelomeningocele, spina bifida’s most severe form, occurs when an opening is left along a baby’s back. Poking out through this hole is a sac, which contains portions of the spinal cord and nerves.

In meningocele, children are born with a similar hole, but the sac protruding through it doesn’t contain any parts of the spinal cord. While nerves may be damaged, this condition is considered less serious than myelomeningocele.

Spina bifida occulta is the condition’s least severe form. Babies are born with a gap separating two portions of the spine, but without a hole in the back or sac outside the body.

Types of Spina Bifida

What Birth Defects Have Been Linked To Zofran?

At least four large studies have found an increased risk of birth defects among babies exposed to Zofran or a generic equivalent during the first trimester.

Researchers from the University of Western Australia reviewed almost 97,000 birth records filed between 2002 and 2005. Analyzing fetal outcomes among babies born to women who had been prescribed Zofran’s active ingredient, the team found that Zofran was associated with a 20% increase in the risk of any major birth defects. The study also identified a six-fold increase in the risk of rare kidney defects.

In 2013, researchers in Denmark reviewed the health outcomes of 903,207 pregnancies. They found that women who had been prescribed Zofran’s active ingredient were 4.8 times more likely to deliver babies with a severe congenital heart defect known as “atrioventricular septal defect.” These women were also more than twice as likely to have babies with atrial and ventricular septal defects. In line with these results, many of the Zofran birth defect lawsuits seek damages for congenital heart defects.

At least one lawsuit has been filed to recover compensation for a child’s cleft palate. A team at Harvard University found that women prescribed Zofran’s active ingredient were 2.37 times more likely to be born with this condition, which occurs when the roof of a child’s mouth fails to close properly during the first trimester.

Why Are Parents Filing Zofran Birth Defect Lawsuits?

Multiple US families have now filed lawsuits against GlaxoSmithKline, the manufacturer of Zofran, in this ongoing birth defect litigation. These parents claim that their children were born with major birth defects caused by exposure to Zofran in early pregnancy.

According to allegations in their complaints, Zofran’s manufacturer promoted the drug as a “safe and effective” treatment during pregnancy, a use for which it was never approved. Zofran was approved by the FDA to treat three specific forms of nausea and vomiting in 1991. But Zofran’s manufacturer never sought approval for its use during pregnancy for any indication. In fact, the company has never conducted a single clinical trial to determine the drug’s effect in pregnant women, or the risks it may pose to unborn children.

In 2012, the federal government made a strikingly similar allegation, and brought a litany of civil and criminal charges against the company. Among the US Department of Justice’s allegations were claims that GlaxoSmithKline had misrepresented Zofran to doctors, promoting it as safe and effective during pregnancy when they had never even studied its effects in pregnant women.

Off label prescription, a common practice in which doctors prescribe drugs to treat conditions for which they have not been approved, is not regulated by the US Food & Drug Administration. But pharmaceutical manufacturers are not permitted to promote their products for off label use under federal law.

In the newly-filed Zofran birth defect lawsuits, families make even more troubling allegations. They say that the drug company has been aware of Zofran’s potential to increase birth defect risks for two decades. The parents claim that, instead of warning the public or alerting the health community to these risks, GlaxoSmithKline continued to promote Zofran for off-label use during pregnancy.

Is My Family Eligible To Bring A Claim Against Zofran’s Manufacturer?

If allegations set forth in these lawsuits are true, any mother who delivered a child with major birth defects after being prescribed Zofran during the first trimester may be entitled to pursue a claim against GlaxoSmithKline.

This website is sponsored by a national coalition of plaintiffs’ attorneys dedicated to advocating for the rights of families. Led by Monheit Law, our lawyers are currently offering free consultations to any parent or birth defect survivor interested in learning more about the Zofran litigation or their own case eligibility.

Contact our experienced attorneys 24 / 7 by calling 1-877-620-8411, or complete our contact form to discuss your own situation with one of our lawyers.