zofran lawsuitIf you or someone you know took the drug Zofran while pregnant between 2000 and 2015 and had a baby with a cleft palate, cleft lip heart defect, or any other serious complications please contact our attorneys for a free case evaluation.

Read our latest article: Morning Sickness Drug Zofran is Linked to Birth Defects

Zofran, known generically as Ondanestron, is a drug marketed to prevent nausea and vomiting caused by surgery, chemotherapy or radiation. The FDA has only approved the use of Zofran for cancer patients recovering from chemo therapy by affecting serotonin levels in the brain. GlaxoSmithKline is the drug manufacturer and their aggressive marketing to doctors for alternate uses of Zofran led to doctors prescribing Zofran for “off-label” use to treat morning sickness in pregnant women. The drug label doesn’t have ANY safety information about the potential risk for birth defects.


Birth Defects
Research published in December 2014 by Dr. Gideon Koren studied more than 900,000 Danish women. Koren found a 2-fold increased risk for cardiac malformations for women that took Zofran. This also led to a 30% increased risk of major congenital malformations. Koren also compared metoclopramide to Zofran. Metoclopramide is also used to treat morning sickness but it was not associated with any birth defects in the first trimester.

Zofran has been linked to an increase risk of the following birth defects:

  • Cleft palate
  • Cleft lip
  • Heart defects or malformations


In 2012 The United States Department of Justice filed a lawsuit claiming the manufacturer GlaxoSmithKline engaged in promoting “Off-Label” use promoting several drugs including Zofran. A $3 billion dollar settlement was the outcome of this litigation.

GlaxoSmithKline admitted that studies had not been conducted with pregnant woman using Zofran.

Women who took Zofran for nausea and vomiting and had a baby with a birth defect are now suing the manufacturer. Our firm is representing these women. If you or someone you know had a baby with a cleft palate, cleft lip or heart defect after taking Zofran, please contact our attorneys for a free case evaluation.


zofran lawsuitStudies Link Zofran and Birth Defects
A 2011 study found that mothers who took Zofran during their first trimester of pregnancy were twice as likely to have a child with a cleft pallet. A cleft palate occurs if the tissue that makes up the roof of the mouth does not join together completely during pregnancy. This generally occurs between the 6th and 9th week of pregnancy.

Additionally, a 2013 study found a doubling in the prevalence of major congenital heart defects in children whose mothers redeemed a prescription for Zofran in the first trimester of pregnancy. These heart defects can include:

  • Atrial septal defect:Hole in the wall between the two upper chambers of the heart.
  • Ventricular septal defect: Hole in the wall between the two lower chambers of the heart.

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