Zofran Alleged To Cause Child Birth Defects
Zofran is a brand name drug manufactured by GlaxoSmithKline, which was approved by the Food and Drug Administration in 1991 for the purpose of treating severe nausea and vomiting in cancer patients and post-operative patients. Shortly thereafter, the drug was promoted “off-label” as “safe” for use by pregnant women to combat morning sickness.
Studies Suggesting Zofran Is Not Safe For Pregnant Women
Over the last number of years there have been several epidemiological studies performed by the medical community which suggests an association between Ondansetron and an increased risk of child birth defects. Specifically, such studies have associated a 2-4 times greater risk of a child being born with an atrial septal defect (also known as ‘hole in the heart’). To read more about the studies, click here.
Zofran Suggested To Increase Probability Of Cleft Palate
In 2012, researchers at Harvard University’s School of Public Health and Boston University’s Slone School of Epidemiology compared the birth outcomes of 4,524 pregnant women who had been prescribed ondansetron during the first trimester to those of 5,859 women who had not sought medical treatment for morning sickness. They found that women who had taken ondansetron as a morning sickness treatment were 2.37 times more likely to deliver babies with a cleft palate.”
Was Zofran FDA Approved For Morning Sickness?
The FDA never approved Zofran for use by pregnant women as a solution to morning sickness. GSK have never taken Zofran through the FDA approval process to seek approval for this use. GSK did not change the indication on Zofran to warn pregnant women of any risks associated with Zofran. To date, GSK continue to deny that they unlawfully marketed Zofran to pregnant women. For more information, click here.
Allegations Of Unlawful “Off-Label” Promotion and Giving Kickbacks To Doctors For Prescribing Zofran
In 2012, the Department of Justice and GSK settled one of the largest pharmaceutical allegations of fraud case in the US. The settlement was for $3 billion. In this case, the DOJ alleged that GSK unlawfully promoted Zofran, among other drugs, for morning sickness, despite it never being approved for that purpose. The lawsuit also alleged that GSK paid kickbacks to doctors for prescribing their drugs to patients. GSK denied these allegations but settled the lawsuit. For more information on the settlement, click here.
Zofran Lawsuits Being Filed Across The Country For Child Birth Defects
As of February 2015, there have been two child birth defect lawsuits filed against the manufacturers of Zofran alleging that Zofran caused 9 different birth defects. These lawsuits were filed in federal court, with one court being the US District Court for the Eastern District of Pennsylvania. To read summaries of each lawsuit, visit:zofran.monheit.com.
Free Consultation – Zofran Birth Defect Lawsuits
If you or a loved one took Zofran for morning sickness during the first trimester of your pregnancy, and your child was born with a cleft lip, cleft palate, atrial septal defect, ventricular septal defect, or kidney malformations, contact Monheit Law today for a free case evaluation.
Mr. Monheit is the father of a child with special needs and pervasive developmental delay, and he sits on the board of the Cleft Lip And Palate Foundation Of Smiles(CLAPFOS). As a result, he knows what you are going through and has helped many parents like you to date. Call today. We will give you the guidance you need.