Zofran Birth Defect

If you suspect you or a loved one suffered birth defects as the result of being prescribed Zofran during early pregnancy, call us today for a free consultation.

Experienced Legal Counsel In Zofran Birth Defect Cases

UPDATE February 18, 2016:  The Cagle Law Firm has helped two families file federal lawsuits in the Zofran Birth Defect litigation.  The Zofran Birth defect lawsuits allege that the Texas families

The Cagle Law Firm, P.C., is now accepting cases for families who have a child who may have suffered birth defects due to the medication Zofran, often prescribed during early pregnancy to combat morning sickness. We are accepting cases in Texas and throughout the United States. We have extensive experience representing clients in a wide range of birth injuries and other medical malpractice lawsuits.

If you suspect you or a loved one suffered birth defects as the result of being prescribed Zofran during early pregnancy, call us today for a free consultation. There is no financial obligation or risk to you. We only collect legal fees or other compensation if we recover money for you and your family.

Call 512-371-6101 or use our online contact form to schedule a free consultation.

What Is Zofran?

The drug Zofran is a 5-HT3 receptor antagonist manufactured by GlaxoSmithKline and is also prescribed in its generic form, ondansetron. Zofran affects serotonin levels in the brain and was originally approved in 1991 to treat nausea and vomiting in cancer patients or following surgery. However, many doctors prescribe it “off-label” to treat nausea and vomiting during pregnancy, otherwise known as “morning sickness.”

A reliable medical study recently described the risks Zofran use poses to the mother and fetus in early pregnancy.

A recent study indicates that use of the drug during pregnancy increases the risk of severe birth defects and injury to the mother. A study published in the December 2014 issue of the American Journal of Obstetrics and Gynecology reported the risks of pregnant women taking Zofran. The study involved 900,000 Danish women and took place in August 2013. The study reported that mothers and their fetuses subjected to Zofran during pregnancy were at a “two-fold increased risk of cardiac malformations with ondansetron (Zofran), leading to an overall 30 percent increased risk of major congenital malformations.”

There are safer alternatives to the use of Zofran to treat morning sickness. Metoclopramide, Doxylamine, and Pyridoxine are drugs used to treat morning sickness that are FDA approved for that purpose and have not been associated with birth defects in the first trimester. The study published in December 2014 notes, “There is no reason for women to be exposed to a drug of unproven maternal and fetal safety” when there are safer options currently available.

The manufacturer of Zofran, GlaxoSmithKline, agreed to pay $3 billion to resolve charges brought by The Department of Justice for the unlawful promotion of Zofran.

The United States Department of Justice sued GlaxoSmithKline for unlawful promotion and failure to report safety data of Zofran. The drug manufacturer plead guilty to illegally promoting the drug to treat morning sickness in pregnant women. The company agreed to pay $3 billion in 2012 to resolve charges.

Women who used the drug during pregnancy gave birth to babies with birth defects, including cleft palates and lips, club feet, heart defects and skull formation abnormalities, which could result in a lack of sufficient space for the brain, which can cause vision problems, eating problems, and cognitive deficits in the child.

Contact us if you or your child may have suffered birth defects as a result of Zofran use.


The Cagle Law Firm, P.C., provides individuals injured through someone else’s negligence personally tailored legal services. Learn about your legal rights and resources below. Call (888) 353-3619 for a free consultation.

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