Zofran Pregnancy Risks: Timeline of Studies on Birth Defects, Malformation

By Austin Kirk
Posted March 13, 2015

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Although Zofran is widely prescribed during pregnancy for morning sickness or hyperemesis gravidarum (HG), there is growing evidence that the medication may increase the risk of birth defects and congenital malformations for children.

While further studies on the safety of Zofran in pregnancy are needed, there is clear evidence that GlaxoSmithKline knew or should have known about the Zofran pregnancy risks.

Rather than fully exploring that potential risk, the drug maker neglected to conduct any large-scale studies and decided to illegally market the medication for use by pregnant women without warning women.

As a result of the drug maker’s reckless actions and failure to warn about risk of using the medication during the first trimester, many children throughout the United States may be entitled to financial compensation through a Zofran pregnancy lawsuit if they suffer from:

• Congenital Heart Disease or Malformations
• Atrial Septal Defects (ASD), Ventricular Septal Defects (VSD), Patent Ductus Arteriosis (PDA), Patent Foramen Ovale (PFO) or Other Heart Defects
• Heart Murmurs, Holes in the Heart, Enlarged Heart, Heart Failure or Other Heart Conditions
• Congental Oral Clefts, such as Cleft Palate or Cleft Lip
• Wrongful Death

The lawyers at Saiontz & Kirk, P.A. provide free consultation and claim evaluation for families who suspect that their child may have a Zofran case.

Zofran Pregnancy Study Timeline

Since Zofran (ondansetron) was introduced in 1991, there have been studies that raised concern about the potential pregnancy risks for unborn children. Through independent research, additional information has surfaced in recent years that suggests a link between Zofran and birth defects:

Mid-1980s: Prior to introducing Zofran, GlaxoSmithKline performed pregnancy studies involving rats and rabbits, which showed evidence that the fetus is exposed to Zofran when used during pregnancy. Although research found evidence of placental transfer of Zofran in pregnant animals, warnings were not provided and the drug maker did not conduct even one large-scale study on the Zofran prenatal risks.

1992: Shortly after Zofran hit the market, adverse event reports were received that suggested a potential risk of birth defects with Zofran use.

2000: Dozens of reports involving Zofran birth defects were received over the first decade the medication was on the market, including instances of congenital heart disease, kidney malformations, facial deformities, intrauterine death, still birth and other problems. Many of these reports were received by GlaxoSmithKline in the same month, or even the same day, yet the drug maker failed to update the warning label to indicate there may be potential Zofran risks for pregnant women.

September 2004: The only Zofran research published in support of use by pregnant women came from a small study involving only 176 pregnancy outcomes. While the findings suggested that Zofran appear to be safe, the limits of the research were only able to rule out a five times increased risk of birth defects.

2006: Researchers from Hong Kong published a study in the International Journal of Obstetrics and Gynecology, which confirmed that Zofran crosses the human placenta at high concentrations. Although the study concluded that further investigation was required, it appears that GlaxoSmithKline ignored the findings and chose to continue to promote Zofran in pregnancy despite the potential risk.

November 2011: A Zofran study published by the medical journal Birth Defects Research Part A: Clinical and Molecular Teratology looked at whether nausea and vomiting in pregnancy was associated with non-heart defects, such as cleft palate or cleft lip. Researchers instead found an association between Zofran and risks of malformations, indicating that children exposed to Zofran prenatally may be 2.37 times more likely to be born with cleft palate.

October 2012: The prominent Canadian physician Gideon Koren, MD, who founded Toronto Hospital for Sick Children’s Motherisk published a report that raised questions about whether Zofran is safe for use during pregnancy. Dr. Koren pointed out that there has been increasing use of Zofran for HG pregnancy or severe morning sickness, despite a lack of data establishing that it is safe. The report concluded that Zofran should be used cautiously only after drugs with better safety records already labeled for use in pregnancy have been tried.

February 2013: A study published by Danish researchers in the New England Journal of Medicine found that Zofran during pregnancy was not associated with a significantly increased risk of adverse fetal outcomes. However, the pregnancies examined had an average gestational age of 10 weeks, which means that half of all pregnant women involved in the study used Zofran after the first-trimester, following organ formation in the fetus and the risk of the congenital heart defects.

August 2013: Follow up research was presented (PDF), which examined the same Danish Medical Birth Registry used in the NEJM study, but expanded the scope and limited data to Zofran first-trimester pregnancy use. The study concluded that children exposed to Zofran were 1.6 times more likely to have a heart defect, with a 2.1 times greater risk of atrial septal defects (ASD) from Zofran and a 4.8 times greater risk of Atrioventricular septal defect (AVSD).

October 2014: A study published in the medical journal Reproductive Toxicology examined Zofran pregnancy use and the risk of heart malformations from data in the Swedish Medical Birth Registry. Researchers identified 1,349 infants exposed to Zofran early in pregnancy between 1998 and 2012, concluding that there is a statistically significant elevated risk for certain cardiovascular defects. Mothers prescribed Zofran early in pregnancy had a 62% increased risk of giving birth to a child with a heart defect, and a 2 fold increased risk of a septal cardiac defect, compared to mothers who did not use the drug.

2015: More than 200 adverse event reports have been submitted involving Zofran birth defects between 1992 and early 2015, with the most common problems involving congenital heart defects. However, other potential problems have been reported involving facial defects, intrauterine death, stillbirth and severe malformations.

Zofran Lawyers for Pregnancy Birth Defects

Although there has been evidence suggesting a clear link between Zofran and pregnancy risks for infants, GlaxoSmithKline not only chose to ignore evidence, but illegally promoted Zofran for HG pregnancy and morning sickness use.

Millions of women throughout the United States experience symptoms of nausea and vomiting in pregnancy every year. GlaxoSmithKline has known that Zofran is widely used by pregnant women, not only because they promoted it directly to OB/GYN physicians in a way that encouraged off-label use, but also because Zofran sales have far exceed those that would be expected from the use of the drug among chemotherapy or surgery patients.

Financial compensation may be available for children who through a Zofran heart defects lawsuit or Zofran cleft palate lawsuit, as GlaxoSmithKline placed their financial interests before the safety of consumers by:

• Failing to adequately research the Zofran pregnancy side effects, which would have negatively impacted sales after confirming the fetal risks;
• Failing to disclose reports of birth defects following Zofran use during the first trimester of pregnancy;
• Failing to warn about the use of Zofran in pregnant women, including evidence that the medication may cross the placenta and increase the risk of heart defects, cleft palate, cleft lip and other congenital malformations.

All cases are investigated by the attorneys at Saiontz & Kirk, P.A. under a contingency fee agreement, which means that there are no out-of-pocket expenses for the family to hire our Zofran lawyers and we receive no fees or expenses unless a recovery is obtained for the child.

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