Was your child born with a defect after you took Zofran (ondansetron)? You may be surprised to learn that the drug was never approved by the U.S. Food and Drug Administration (FDA) to treat morning sickness in pregnant women. In spite of this, drugmaker GlaxoSmithKline (GSK) marketed Zofran for this very purpose, prioritizing profits above the wellbeing of expectant mothers and their infants in a shocking display of negligence.
Since then, multiple reports of serious fetal injuries resulting from Zofran use have been brought forward. For illegally promoting the drug’s “off-label” usage, GSK paid a $2 billion settlement in a civil lawsuit in 2012. This settlement did not include payments for damages suffered due to the use of Zofran. As Zofran birth defect victims, you and your child may be entitled to compensation for medical costs, emotional distress, loss of income, and other damages.
The Wilshire…show more content… Although the FDA approved the use of Zofran only for the treatment of nausea and vomiting in cancer patients, GSK promoted the drug to physicians as a viable treatment option for pregnant women experiencing severe nausea. This would later prove ill-advised.
Several medical studies published in recent years have linked Zofran to the increased occurrence of major birth defects:
• In August 2013, a group of researchers compared outcomes among nearly 900,000 women who took Zofran during pregnancy between 1997-2010. They found that Zofran was associated with a doubled risk of heart defects, contributing to a 30 percent increased risk of birth defects overall.
• In December 2013, Australian researchers linked the use of Zofran in the first trimester with a non-significant 20 percent increased risk of birth defects.
• In December 2014, a study was published in Reproductive Toxicology that indicated a doubled risk of septal heart defects in infants whose mothers took Zofran during early pregnancy from