Zofran, a potent anti-nausea drug manufactured by GlaxoSmithKline, was initially approved by the US Food & Drug Administration in 1991. Almost immediately after that first approval, physicians began prescribing Zofran to pregnant women, to alleviate the symptoms of nausea and vomiting that commonly accompany the first trimester.
But Zofran had not been approved for use during pregnancy, or as a morning sickness treatment for that matter. It had been approved to treat the most severe nausea and vomiting imaginable, that experienced by cancer patients undergoing chemotherapy.
Zofran & Pregnancy: Does This Common Anti-Nausea Drug Increase The Risk Of Major Birth Defects?
Since 1991, Zofran’s use as an “off label” morning sickness treatment has only grown; recent estimates have suggested that US doctors write around 1 million Zofran prescriptions to pregnant women every year. And while the drug’s approval was eventually extended to include cancer patients undergoing radiotherapy, as well as surgical patients receiving anesthesia, GlaxoSmithKline has never attempted to have the drug approved for use in pregnancy.
In fact, the company hasn’t even studied Zofran’s effects on pregnant women or their unborn babies.
Zofran, Pregnancy & Birth Defects: What Have Researchers Found?
But now that hundreds of thousands of pregnant women have taken Zofran during the first trimester, scientific researchers have begun to investigate the effects of this drug on fetal development. At least four of these studies have found an association between Zofran and significantly increased risks for birth defects.
Researchers From Harvard & Boston Universities Find Increased Risk Of Cleft Palate
The first major study to examine Zofran’s potential risks for unborn babies was completed in 2012. Published in Birth Defects Research: Part A, Clinical & Molecular Teratology, this study conducted by researchers at Harvard University and Boston University reviewed the prescription and birth records from 10,383 US pregnancies. When administered to pregnant women during the first trimester, Zofran’s active ingredient was found to be associated with a 2.37 times elevated risk for cleft palate.
Teams In Denmark & Sweden Find Association Between Zofran & Congenital Heart Defects
In 2013, two teams of Danish researchers reviewed hundreds of thousands of birth records filed in Denmark.
The first team looked at more than 600,000 records spanning from 2004 to 2011. Supplemental materials published along with their article in The New England Journal of Medicine indicated that women who were exposed to Zofran’s active ingredient during pregnancy were at increased risks of delivering babies with congenital heart defects. Specifically, the data suggested an increased risk for “cardiac septal defects.”
This category of abnormalities, commonly referred to as “hole in the heart” defects, occurs when babies are born with openings in cardiac walls that are normally unbroken. Among other elevated risks, the data suggested that babies exposed to Zofran prenatally were more than four times as likely to be born with atrioventricular septal defects.
The second team expanded the first study’s scope, including every live birth between 1997 and 2010. Ultimately, researchers reviewed more than 900,000 pregnancies. And while only 1,368 of these women had been prescribed Zofran as a morning sickness treatment, the study’s results were unequivocal, finding “an increase in the prevalence of major congenital heart defects.”
Women prescribed Zofran’s active ingredient were:
- 20% more likely to deliver babies with any congenital malformation
- 60% more likely to deliver babies with a congenital heart defect
- 210% more likely to deliver babies with an atrial septal defect
- 230% more likely to deliver babies with a ventricular septal defect
- 480% more likely to deliver babies with an atrioventricular septal defect
Unlike the first Danish paper, this second study made a crucial distinction between pregnancies exposed to Zofran during the first trimester and ones exposed after that. In searching for the drug’s potential risks, researchers did not consider pregnant women who had been prescribed Zofran’s active ingredient during the second or third trimesters. Medical experts have noted that the first study’s inclusion of women who were prescribed Zofran after the first trimester could have minimized the drug’s potential risks, since unborn babies are far less likely to develop birth defects after around 10 weeks of development.
The most recent study of Zofran’s effects on fetal development was completed in 2014. Publishing their results in the peer-reviewed journal Reproductive Toxicology, scientists from Sweden’s National Board of Health and Welfare identified every Swedish pregnancy exposed to Zofran’s active ingredient between 1998 and 2012, a total of 1,349 live births. They concluded that these babies were 62% more likely to be born with cardiovascular defects, and more than twice as likely to be born with cardiac septal defects.
In response to these results, many noted pregnancy experts have urged caution, although neither the FDA nor GlaxoSmithKline have yet addressed the studies’ findings publicly.
Why Have Parents Filed Zofran Birth Defect Lawsuits?
You may have heard that several American families have filed legal claims against GlaxoSmithKline, Zofran’s manufacturer. These parents say that they were prescribed Zofran as an “off label” treatment for morning sickness, and that prenatal exposure to the drug caused their unborn children to develop major birth defects.
Families claim that GlaxoSmithKline unlawfully bypassed the FDA approval process, marketing Zofran directly to doctors as a “safe and effective” drug for pregnant women to take without ever investigating its possible effects during pregnancy. In fact, parents have alleged that the company chose to leave the possible risks of Zofran and pregnancy unstudied, because the results could have jeopardized sales and profits.
In support of these claims, plaintiffs cite a 2012 lawsuit in which the federal government charged GlaxoSmithKline for promoting several drugs, including Zofran, for unapproved uses. Ultimately, the company entered a settlement agreement with the US Department of Justice, consenting to pay a total of $3 billion, although GlaxoSmithKline continues to deny that it unlawfully marketed Zofran as a safe and effective treatment for morning sickness.
According to plaintiffs, GlaxoSmithKline promoted Zofran for use during pregnancy even in the face of mounting evidence that the drug could increase birth defect risks. They cite the studies we reviewed above in support of this allegation, as well as more than 200 reports of birth defects that they say GlaxoSmithKline has received over the last two decades. But as they note, Zofran’s warning label makes no mention of these severe “adverse events.” Nor does the drug’s labeling information refer to the four studies that have found an increased risk of major birth defects among babies prenatally exposed to Zofran’s active ingredients. This is information that plaintiffs say GlaxoSmithKline has withheld from the medical community and public.
Can My Family File A Zofran Birth Defect Claim?
Zofran.Monheit.com is sponsored by Monheit Law, a personal injury firm devoted to advocating for the rights of families and birth defect survivors. Led by Michael Monheit, Esq., Monheit Law has gathered a multi-state alliance of plaintiffs’ attorneys to investigate the claims of parents who believe that prenatal exposure to Zofran may have caused their children to be born with birth defects.
Our attorneys are currently providing free consultations to families interested in learning more about the ongoing Zofran litigation and their own case eligibility. To speak with an experienced lawyer, call 1-877-620-8411 or fill out our online contact form today.