Side Effects of Zofran in Pregnancy May Cause Injury to Children

The product liability lawyers at Saiontz & Kirk, P.A. are reviewing potential claims for children born with congenital malformations or birth defects that may have been caused by exposure to Zofran during pregnancy.

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Saiontz & Kirk, PA, Attorneys & Lawyers, Baltimore, MD

Zofran (ondansetron) is a popular anti-nausea/vomiting drug, which has been widely prescribed off-label to pregnant women for morning sickness.

Potential pregnancy side effects of Zofran have been linked to an increased risk of unborn babies developing serious and potentially life-threatening health problems, including:

  • Cleft Palate
  • Cleft Lip
  • Atrial Septal Defects
  • Ventricular Septal Defects
  • Other Heart Malformations

As a result of the drug maker’s failure to warn women and the medical community about the potential pregnancy effects on the fetus, settlements may be available through a Zofran lawsuit for children who have experienced health problems.

To review a potential claim for yourself, a friend or family member request a free consultation and claim evaluation.

Zofran Pregnancy Risks

Zofran is a 5-HT3 receptor antagonist sold by GlaxoSmithKline, which works on the nervous system, blocking serotonin and increasing gastric emptying. This helps reduce nausea and vomiting.

Although Zofran was only approved for use among chemotherapy patients and surgical patients, the medication has been illegally marketed for “off-label” use as a morning sickness drug by pregnant women, even though GlaxoSmithKline failed to establish that it is safe for the fetus.

Morning sickness is one of the most common problems experienced by pregnant women, with an estimated 75% of women experiencing nausea or vomiting during the first trimester of pregnancy. Therefore, encouraging prescription of Zofran for morning sickness widely expanded the market for this drug.

While Zofran pregnancy warnings indicate that there is no adequate and well-controlled research involving the effects of the drug on unborn children, GlaxoSmithKline appears to have illegally marketed the drug for use by pregnant women and withheld information about a potential link between birth defects and Zofran use during the first trimester of pregnancy.

If GlaxoSmithKline had adequately studied the potential Zofran risks and provided warnings to women and the medical community, many children may have avoided serious and debilitating birth defects and congenital malformations.

Studies on Zofran Fetal Side Effects

As early as 2006, a study published in the medical journal Clinical Pharmacokinetics suggested that there may be a risk of fetal side effects from Zofran, finding evidence that the medication crosses the placenta.


In January 2012, a large control study published in the medical journal Birth Defects Research Part A: Clinical and Molecular Teratology found a link between Zofran and cleft palate, indicating that women prescribed the medication for morning sickness during the first trimester may be 2.3x more likely to give birth to a child with this facial malformation.

Cleft palate is a congenital birth defect, where the roof of the baby’s mouth fails to properly develop and close. These findings have also raised concerns that side effects of Zofran may also cause cleft lip, where the baby is left with a split in the upper lip.

Babies born with a Cleft Lip or Cleft Palate from Zofran pregnancy use often require surgery during the first year of life and may be left with serious health problems, including:

  • Chronic Malnutrition
  • Hearing Impairment
  • Dental Problems
  • Speech Delays
  • Physical Deformity and Scars


Concerns about the potential link between heart defects and Zofran pregnancy use were highlighted in a study presented in August 2013 (PDF) at the International Society of Pharmacoepidemiology meeting in Montreal.

Researchers examined data involving 900,000 pregnancies and identified 1,248 women who filled a prescription for Zofran during the first trimester.

Zofran pregnancy use was associated with a 30% overall increased risk of congenital malformations, but the most prevalent problems involved heart defects, such as atrial septal defects. Researchers indicated that women who used Zofran while pregnant may be two-times more likely to give birth to a child with heart problems.

While an earlier study published in the New England Journal of Medicine (NEJM) suggested that Zofran during pregnancy was not associated with a significantly increased risk of major birth defects, the average gestational age of exposure to Zofran in this study was 10 weeks. Therefore, experts have pointed out that at least half of the women evaluated used Zofran after the risk of birth defects or malformations during the first trimester may have passed.

Potential heart defects from Zofran side effects may include:

  • Atrial Septal Defects: Involving an opening in the wall between the upper left and upper right chambers of the heart, causing oxygen rich blood to leak into the chamber that holds oxygen depleted blood. This can cause poor blood flow and decreased oxygen supply to the body.
  • Ventricular Septal Defects: Involves a hole in the heart between the lower chambers, which causes oxygen-rich blood to be pumped back to the lungs, rather than to the rest of the body. As a result the heart must work harder, which could lead to heart complications.
  • Heart Murmur: Abnormal heart beat or extra sound heard in the heart, which could be an indication of a heart defect.

Lawsuits for Birth Defects from Zofran Side Effects

As a result of GlaxoSmithKline’s failure to adequately warn about the potential Zofran side effects for unborn babies, children born with congenital malformations or birth defects from Zofran may be entitled to financial compensation through a product liability lawsuits.

Free consultations and claim evaluations are provided for families where a child was born with a cleft lip, cleft palate or heart defects that may have been caused by Zofran use during pregnancy.

All cases are handled by our Zofran attorneys under a contingency fee agreement, which means that there are no out-of-pocket expenses to hire our law firm and there are never any fees unless a recovery is obtained for a Zofran birth defect.