Zofran Heart Defects
Types of Zofran Heart Defects Detected in Fetuses
When a pregnant mother takes Zofran, particularly during the first trimester of development, the developing fetus is put at risk for a range of birth defects and health conditions. Zofran heart defects include atrial septal defect, ventricular septal defect, and heart murmur. Other health problems and defects that can occur in fetus include physical deformities such as cleft palate.
In 2013, a group of Danish researchers issued a strong warning against the use of Zofran during pregnancy when they concluded that fetuses exposed to Zofran during the first trimester of development face a two-fold risk of heart defects. More than 900,000 birth records were examined to produce this data, signifying the largest research study conducted yet on Zofran heart defects. The following congenital heart defects were linked to Zofran exposure from this research:
Zofran Atrial Septal Defect
This heart defect is characterized by an opening in the septum between the upper-left and upper-right chambers of the heart, known as the atria. Atrial septal defect can cause damage to the heart and lungs and may require a baby to undergo one or more surgeries.
Zofran Ventricular Septal Defect
Commonly referred to as a “hole in the heart”, ventricular septal defect is characterized by a heart defect locatedin the septum, which is the wall between the lower-left and lower-right chambers of the heart. Ventricular septal defect allows oxygen rich blood to travel from the left side of the heart to the right, sending it back to the lungs to be oxygenated again. This condition forces the heart to work harder, and can result in long term complications if not resolved through surgery.
Zofran Heart Murmur
A heart murmur is an abnormality in the heart beat that can be indicative of an underlying heard condition that could be dangerous to the baby.
Zofran Heart Defects Research
Studies on heart defects caused by Zofran show prescribing this drug to pregnant women is unsafe. Many pregnant women feel confused when they research Zofran heart defects – research results have not all been in agreement on the level of risk a fetus faces from Zofran. Studies conducted with a very small sample size have concluded that Zofran birth defects are not a risk. However, large studies show there is a risk of heart defects for babies exposed to Zofran in utero. Prescribing Zofran to pregnant women is not recommended by the FDA.
- 2004: Motherisk in Canada produced a study indicating no link between Zofran and heart defects. The study, which included only 200 mothers, was the only existing research until 2013.
- February 2013: The New England Journal of Medicine published a study based on select Danish birth records dating from 2004 – 2011. This study did not detect a link between Zofran and heart defects. This study was problematic on two accounts: the sample size was small, and many mothers in the study did not start taking Zofran until after 10 weeks of gestation, meaning their fetus had already passed the critical stage where the risk of heart defects exists.
- August 2013: A much larger study was conducted on Danish birth outcomes, including births dating from 1997 to 2010. This research, which is by far the biggest and most reliable look at Zofran heart defects, found the drug doubles the risk of congenital heart defects and increases the risk of birth defects overall by 30%. The sample group included 1,248 women who took Zofran during their first trimester of pregnancy.
Zofran Heart Problems and the FDA
Zofran is currently under FDA investigation for serious health problems including Serotonin Syndrome and heart problems. When pregnant women suffer these side effects from Zofran, their fetus can also be endangered. Adverse event reporting indicates that Zofran can cause these serious side effects; the FDA is still investigating the drug to learn more about the dangers it poses to pregnant women and the general public. The FDA has issued numerous Safety Communications regarding potential health problems that can stem from Zofran exposure. Zofran is categorized as a Pregnancy Category B drug, meaning there is inadequate testing on the safety of the drug for prenatal women.
Zofran is the brand name for ondansetron, and is sold by GlaxoSmithKline. An ant-emetic, Zofran is used to prevent nausea and vomiting. The use this drug during pregnancy, and particularly during the highly-sensitive first trimester, has been found to cause Zofran heart defects in fetuses. is an anti-nausea drug that has been linked to a risk of birth defects when taken during pregnancy. Zofran heart defects research shows that the drug increases a fetus’ risk for heart defects by two-fold.
First approved by the FDA in 1991, Zofran has never been approved for use by pregnant women. One of several anti-emetic pharmaceuticals in the 5-HT3 receptor antagonist class of medicines. Available in both a rapidly-disintegrating tablet and via injection, Zofran reduces nausea and vomiting by blocking the effect of serotonin, a naturally occurring chemical in the body.
Zofran in Pregnancy Federal Lawsuit
GlaxoSmithKline settled a major lawsuit with the U.S. Department of Justice (D.O.J.) in 2012 over the off-label marketing of Zofran and other drugs. Off-label marketing means GlaxoSmithKline was caught advertising Zofran for pregnant women, even though there was no reason to believe that was safe. To settle a number of civil and criminal charges, GlaxoSmithKline paid $3 billion to the DOJ. By developing advertising that encouraged pregnant women to take Zofran, GSK put American babies at risk of heart defects during the most crucial period of their prenatal growth.
National Zofran Heart Defect Lawyers Offer Free Case Review
Our attorneys handling Zofran heart defect lawsuits on behalf of mothers and families whose babies suffered birth defects after exposure to Zofran. They will work tirelessly on your behalf to assure you get the compensation you deserve. If you or a loved meets this description, complete the contact form at the right of your screen and a Zofran heart defects attorney will respond to answer your questions and giving you a sense of your legal options. Zofran heart defects attorneys provide free, no-obligation case review.
Zofran Heart Defect Lawsuits
Individuals and families whose baby was born with a heart defect from Zofran may have grounds for a Zofran heart defect lawsuit. We provide legal representation for Zofran heart defects lawsuits on a contingency basis, meaning that we never charge a fee unless we win compensation on your behalf.