Zofran Birth Defects

Published on March 2, 2015 by Sandy Liebhard

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In 2013, more than 1 million expectant mothers were prescribed Zofran (Ondansetron) or Zuplenz to control nausea and vomiting during their pregnancy. In spite of this, the safety of Zofran in relation to a developing fetus has never been well-evaluated, and the medication has never been approved to treat gastric distress associated with pregnancy. Now, a growing body of evidence has begun to link Zofran with birth defects, and a number of legal claims have been filed in U.S. courts on behalf of children who were allegedly harmed by their mothers’ exposure to Zofran while expecting.

If you believe your child is the victim of a Zofran birth defect, it is vital that you seek legal advice as soon as possible. Pursuing a claim against GlaxoSmithKline could ensure that you have access to the resources required to meet all of your child’s needs, medical and otherwise. The nationwide law firm of Bernstein Liebhard LLP can provide you with a free legal consultation to determine if you might be eligible to file a Zofran lawsuit on behalf of your child. To learn more, please contact a member of our legal staff by calling our office at .

Zofran and Pregnancy

The U.S. Food & Drug Administration (FDA) has placed Zofran in Pregnancy Category B, which means that there have been no well-controlled studies of its effects in pregnancy. Early studies of the issue were reassuring. For example, in February 2013, research involving more than 600,000 Danish mothers, including nearly 2,000 who were treated with Zofran during their pregnancy, found no risk. However, half of the women included in the study received the drug after their 10th week of gestation, which is beyond the time when most fetal malformations will occur.

zofran brth defectsThe reassurance provided by that research was short-lived, however. Later that year, scientists using data from the same Danish health registry concluded that women who took Zofran during the first trimester of pregnancy were 30% more likely to have a baby with a major birth defect. The study also concluded that the drug was associated with a 2-fold increased risks of major cardiac malformations. While the earlier research had only looked at data from 2004 through 2011, the authors of the second study used data from a 13-year period. The later study also drew from a larger pool of subjects, as it included nearly 900,000 women, of which some 1,248 received Zofran early in pregnancy.

In January 2012, research that looked at data from the National Birth Defects Prevention Study found that Zofran use during the first trimester of pregnancy was associated with a 2.37-fold increase in the incidence of oral clefts, such as cleft lip and cleft palate. A study published in December 2014 in Reproductive Toxicology found that pre-natal exposure to Zofran was associated with double the risk of septal heart defects, including atrial septal defects and ventricular septal defects.

Zofran Litigation

In February 2014, the first Zofran birth defect lawsuits were filed in federal court on behalf of children who allegedly suffered serious heart abnormalities due to their mothers’ use of Zofran during pregnancy. The lawsuits claim that GlaxoSmithKline failed to warn patients that Zofran could harm a developing fetus, and that the company aggressively promoted the drug to treat nausea and vomiting during pregnancy even though Zofran had never been approved for this use. Among other things, the complaints point out that in 2012, GlaxoSmithKline agreed to pay $3 billion to settle charges with the federal government involving Zofran and other drugs. Among other things, the company had been accused of improperly promoting the off-label use of Zofran for morning sickness.

The legal team at Bernstein Liebhard LLP is now investigating Zofran birth defect claims involving:

If you believe Zofran caused your child’s birth defect, please contact our office today to learn more about your options. A member of our legal staff will take the time to answer all of your questions regarding the process for filing a lawsuit. Simply call to arrange for your free, no-obligation case review.

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