The drug Zofran (Ondansetron) has been linked by at least four studies to an increased risk of birth defects. Zofran was approved by the FDA in 1991 only for the treatment of nausea experienced by chemotherapy and radiation patients, as well as for patients who experienced nausea following a surgical procedure. Zofran officials, however, touted the drug to doctors as a cure for severe morning sickness experienced during the first trimester of pregnancy. This is known as “off-label” use, and, while off-label prescribing is fairly common, it can lead to serious medical issues.

In this case, studies have found that when pregnant women take Zofran during the first trimester of their pregnancy, severe birth defects can result. One epidemiological review performed by researchers at Harvard and Boston University which studied more than 10,000 birth records concluded women who took Zofran for morning sickness were more than twice as likely to deliver a baby with a cleft palate. Three additional studies have found increased risks of birth defects when Zofran is taken during the first three months of a woman’s pregnancy.

• Danish researchers conducted a second study of birth records filed between 1997 and 2010 after a first noted no increased risk of major birth defects in babies exposed to Zofran. The first study was considered biased because more than half the women in the study took Zofran after the first trimester. The second study included only women exposed to Zofran during the first trimester. Out of more than 900,000 live births, 1,368 of the mothers took Zofran for severe morning sickness during the first trimester. Approximately 4.7 percent of those mothers gave birth to children with major birth defects as compared to 3.5 percent in the group of mothers who did not take Zofran. Researchers translated these numbers into a 20 percent increased risk of major congenital defects for those taking Zofran in the first trimester. Conclusions were that babies exposed to Zofran were 2.1 times more likely to suffer an atrial septal defect, 4.8 times more likely to suffer a atrioventricular defect and 2.3 times more likely to experience a ventricular septal defect. These defects are commonly known as a hole in the heart and are the result of cardiac tissues which do not develop properly.
• A Swedish study published in December, 2014, came to many of the same conclusions as the Danish study. Records were compiled from the Swedish Medical Birth Record for a period of fifteen years (1998-2012), identifying 1,349 babies born to mothers who took Zofran during the early months of pregnancy. The incidence of heart defects and cleft palate in the group of babies born to women who took Zofran was compared to all other births during the same time period. The Swedish study found babies exposed to Zofran were approximately 1.6 times more likely to have a congenital heart defect.
• In 2013, an Australian medical journal published a study regarding the off-label use of Zofran among expectant mothers. Western Australian birth records between 2002 and 2005 were compiled, determining that 251 women out of more than 96,000 had taken Zofran during the early months of pregnancy. The Australian study found a 20 percent increased risk of major birth defects among women who took Zofran during the first trimester of their pregnancy. A seven-fold increase in the risk of kidney malformations was also found. It was noted that this particular study may have been too small to properly assess the actual risks of Zofran birth defects.

Lawsuits Filed Against the Manufacturer of Zofran

Lawsuits have been filed against the manufacturer of Zofran, GlaxcoSmithKline (GSK). These lawsuits allege GSK was well aware of the potential dangers associated with Zofran when taken by pregnant women. No clinical human trials were conducted in order to determine whether Zofran is safe for use in pregnant women, although animal studies in pregnant rabbits and rats were performed in the late 1980’s. Each of four animal studies revealed signs of toxicity including lethargy and abnormal postures in the pregnant animals and impaired bone growth in the babies when Zofran was administered during early pregnancy. It is expected more Zofran lawsuits will be filed as more information regarding Zofran risks surface.

Contact Our National Dangerous Drug Lawyers

If you took Zofran during the first trimester of pregnancy and your baby was born with a congenital defect, it is important to speak one of the experienced national dangerous drug attorneys at Golomb & Honik immediately. Our lawyers can answer all your questions regarding the current Zofran litigation and determine if you are eligible to file a lawsuit against the manufacturers of Zofran.