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The Dangers of Zofran

About the Recent Zofran Lawsuit

Recent lawsuits have been filed alleging that the popular and powerful anti-nausea drug, Zofran, when ingested by pregnant women, may increase the risk of birth defects including cleft lip, cleft palate and serious cardiac issues. en Espanol

pregnant woman suffering nausea from morning sickness

Zofran, manufactured by pharmaceutical industry giant GlaxoSmithKline, and also known by its generic form, ondansetron (pronounced on-dance-etron), was never approved by the FDA for use by pregnant women. The only people that Zofran is FDA-approved for are cancer chemotherapy patients, cancer patients receiving total body irradiation or radiotherapy to the abdomen, and surgical patients where nausea and/or vomiting must be avoided post-operatively.

A Stanford University research study indicates that when Zofran is ingested by a pregnant woman, the drug “readily crosses the placenta” and “has a significantly longer elimination half-life in neonates compared to their mother.” Thus, the medication stays in the fetus or the newborn far longer than it remains in the mother. The Stanford study also recognizes that ondansetron is often added to spinal anesthesia during a caesarean childbirth to minimize nausea in the mother.

Off-label use of Zofran

Though Zofran’s developer, GlaxoSmithKline never sought FDA approval for use by pregnant women, already filed lawsuits allege that the pharmaceutical company has marketed the drug for such “off-label” use.

“Off-label” use of ondansetron by pregnant women is suspected to have contributed to an increase in babies being born with:

  • Craniofacial clefts, such as cleft lip and cleft palate
  • Congenital heart defects, such as hole in the heart, high blood pressure and irregular heartbeat
  • Pinna abnormalities – low-set ears
  • Syndactyly – webbed toes (two or more toes fused together)
  • Hearing loss
  • Kidney malformations
  • Sensitivity to light
  • Ingueno hernia
  • Jaundice

Related 2012 GlaxoSmithKline Lawsuit Settlement

In 2012, Glaxo agreed to a $3 billion dollar settlement with the U.S. Department of Justice over claims that the company had marketed 5 different drugs including Zofran illegally. While this was the largest pharmaceutical lawsuit settlement in history, none of the money went to compensate a single mother or child that was ever misled or uninformed about the risk of using Zofran during pregnancy. Among the government’s allegations that led to the 2012 settlement:

  1. GlaxoSmithKline promoted the sale and use of Zofran for conditions other than those for which its use was approved, including pregnancy-related nausea.
  2. GlaxoSmithKline made false representations or statements about the safety of Zofran as a treatment for pregnancy-related nausea.
  3. GlaxoSmithKline made illegal payments to health care professionals to induce them to promote and prescribe Zofran.

If you took Zofran while pregnant, you are not alone

If you did take Zofran or its generic equivalent while you were pregnant, rest assured that you’re not alone. According to a December 2014 article in the American Journal of Obstetrics and Gynecology, Dr. Gideon Koren claims that nausea and vomiting of pregnancy (NVP) is the most common medical condition in pregnancy, affecting an estimated 80% of pregnant women. And, unfortunately, for over 30 years there was no anti-nausea medication safety-approved by the FDA for use by expectant moms in the United States.

“Based on the data available today, ondansetron use cannot be assumed to be safe during pregnancy.” – Gideon Koren, MD, a pediatrician and researcher who specializes in studying the effects of drugs and chemicals on the fetus

If you took Zofran or its generic equivalent while pregnant, and your child has medical issues, please contact trial attorney Bruce Hagen so we can discuss your particular case. Talking with Bruce and discussing the merits of your case is free, and there is absolutely no obligation on your part to pursue a lawsuit. If you decide to team with us and pursue a case against GlaxoSmithKline, we will only collect a fee if your case results in a successful win or settlement.

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