Zofran Linked to Birth Defects In Pregnancy Studies

A study was published in the New England Journal of Medicine in February of 2013 which found no link to birth defects after using Zofran during pregnancy. However, there have been other studies done which dispute this conclusion.

Initial Zofran Side Effects Study Flawed

The major flaw cited in the original study is that the data was taken from a Danish registry, comparing outcomes of almost 2,000 patients who were administered Zofran for nausea during pregnancy between 2004 and 2011. Half of the women in the study started using Zofran after 10 weeks of genstation, after the baby was at a much lower risk of developing major birth defects.

More Comprehensive Zofran Side Effects Study Done

Another team of researchers studied the same data in August of 2013, but used a larger sample size. Their research included nearly 900,000 patients and covered a longer span of time, from 1997 to 2011. With a larger sample size, statistical data is typically closer to the norm, yielding more accurate results. The larger, more comprehensive study concluded that women administered Zofran during pregnancy faced double the risk of heart defects, and a 30% increased risk of birth defects on average.

Side Effects Linked to Zofran Use During Pregnancy

• Birth Defects
• Heart Murmur
• Heart Defects
• Kidney Defects
• Atrial Septal Defect (Hole in the Heart)
• Cleft Palate, Cleft Lip
• Jaundice
• Poor Fetal Growth (In the Womb)
• Life Threatening Complications During Pregnancy
• Death

Third Study Shows Devastating Outcomes

In December of 2009, the Toronto Star reported that birth defects including heart defects were associated to the use of Zofran during pregnancy. There were some disturbing results found during this study, including:

• Multiple reports of heart defects
• Multiple reports of kidney malformations
• At least one infant was born with a “musculoskeletal abnormality”
• Six infants suffered fetal growth restrictions, four of them weighed as little as 4.5 pounds at birth

Ondansetron – The Active Ingredient in Oral Zofran

Before taking Zofran, be sure to ask your physician about precautions. WebMD.com lists several, one of which states: “Ondansetron may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.”

Zofran Side Effects Lawsuits

There have been numerous lawsuits filed due to the harmful side effects of Zofran, but time is running out. If you or someone you know has been prescribed Zofan during pregnancy, contact an experienced Zofran Side Effects attorney at the Stampfle Law Firm right away for a Free Consultation about your case.

Our South Carolina Zofran Side Effects attorneys have litigated a large number of defective or harmful drugs on behalf of our clients. We do not back down from a fight with large pharmaceutical companies, and we will fight to get you the compensation you deserve.