Zofran an anti-nausea drug manufactured by GlaxoSmithKlein  is often given to women during pregnancy for morning sickness. Zofran is not FDA approved to be taken by women for morning sickness during pregnancy. This “off label use” by Doctors may be putting the newborn in serious and increased risk of birth defects especially for women in the 1st trimester through the end of the 2nd trimester. It is during this critical time, that congenital heart defects and cleft lip and cleft palate defects can most likely occur to the fetus.

Zofran® for Morning Sickness Not Approved by FDA

Zofran (Ondansetron) is a serotonin 5-HT3 receptor antagonist originally manufactured and marketed  to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy. It is for these uses that Zofran was given its initial FDA approval. Only later did ObGyn’s and other Doctors start “off label use” by prescribing Zofran for morning sickness.  The Zofran Pregnancy Safety Category is a Category B, though many experts would argue that increased warnings, Black Box Warnings for Zofran and a new Pregnancy Category C for Zofran is needed. The safety of Zofran for pregnant women has not proven by medical studies. To the contrary, medical studies have in fact shown increased risks to the baby / fetus when the pregnant mom is taking Zofran in the first and second trimesters.

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According to a 2014 study the using Zofran during pregnancy for NVP can increase the risk of  hypospadias, cleft palate, cleft lip, congenital heart defects, and possibly neural tube defects. Other Zofran medical studies have opposing conclusions.

Zofran Lawsuit for Birth Defects

Willis Law Firm is currently representing a number of families of children with Zofran birth defects. These babies were born to mothers that took Zofran in her pregnancy and later the babies were born with a serious Zofran birth defect.  In a Zofran Lawsuit for birth defects, some of the legal elements of damages include a plea for medical expenses (past & future), pain and suffering, disfigurement, loss wages and other monetary damages for the injuries that the child and the parents have suffered as a result of these birth defects.

Talk to a Board Certified Personal Injury Trial Lawyer licensed in Texas and in New York with a National Birth Defect Litigation Presence with the Highest Peer Review Rating.  All Zofran cases are taken on a contingency fee basis and the client is never charged an attorney fee or any legal case expenses unless a recovery is obtained.

To contact a lawyer to discuss a potential Zofran Lawsuit call us Toll Free 1-800-883-9858

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