Reassuring Zofran Birth Defect Study Made Headlines in 2013, Contradicted Just Months Later

Published on April 1, 2015 by Sandy Liebhard

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In 2013, a Zofran birth defect study offered what appeared to be reassurance to expectant mothers who relied on the anti-nausea drug to relieve nausea and vomiting related to their pregnancies. But just months later, a second study drawing data from the same Danish health registry reported disturbing findings which suggested that pre-natal exposure to Zofran could increase the likelihood that a child would be born with serious congenital abnormalities.

Conflicting Zofran Studies

The first study was published in the February 2013 issue of the New England Journal of Medicine, and looked at more than 600,000 pregnancies included in the Danish registry between 2004 and 2011. The study concluded that Zofran use was not associated with fetal harm, although it could not rule any specific birth defects.

The findings of the NEJM study were widely reported in the media upon its publication, with many reports featuring medical experts who assured pregnant woman that they could use Zofran without fear to control gastric distress.

“It’s effective and it’s safe,” one doctor told the Associated Press at the time. “Nobody is giving you a gold star for suffering through this.

Unfortunately, the comfort provided by the NEJM article was short-lived. In August 2013, another group of researchers presented findings from a second study which suggested that first-trimester Zofran use was associated with a significantly increased risk for major birth defects, including heart malformations. The second study covered more pregnant women (more than 800,000), and a longer period of time (1997 through 2010).

Both the number of pregnancies, as well as the differing time periods covered by each of the studies could help account for their conflicting findings. An analysis conducted in late 2014 by Canada’s MotherRisk program also pointed out that half of the pregnancies included in the first study were exposed to Zofran after the 10th week of pregnancy, which is beyond the time when many major malformations occur. “This can cause a bias toward the null, diluting an existing risk because of inclusion of cases that were not exposed during embryogenesis,” the analysis stated.

It should be noted that additional research has been published which suggests an association between Zofran and birth defects. In January 2012, for example, an analysis based on data from the National Birth Defects Prevention Study reported that women who where exposed to Zofran during their first trimester of pregnancy were 2.37 times more likely to have a baby with an oral cleft, such as a cleft lip or cleft palate. In December 2014, research appearing in Reproductive Toxicology indicated that pre-natal exposure to Zofran was associated with a two-fold risk of septal heart defects, including atrial septal defects and ventricular septal defects.

Zofran Lawsuits Now Being Evaluated

Since early 2015, a number of Zofran lawsuits have been filed in U.S. courts on behalf of children who allegedly suffered birth defects due to pre-natal exposure to the drug. If you took Zofran during the first trimester of pregnancy and your baby was born with an oral cleft, heart malformation or other serious birth defect, please call (888) 881-3077 to learn how you can begin the process of filing a case on behalf of your child.

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