Zofran Birth Defects Alleged in Lawsuit: FDA and Research Question Safety


During pregnancy, there are a plethora of risks and considerations for the expectant mother. Along with the joy that having a child brings, there are also the stresses of nutrition, dietary support, medication restrictions, planning for labor and delivery, and much more. All of these concerns make it extremely important for expectant parents to have healthcare providers they can trust managing their care.

Because there are so many medication risks during pregnancy, it is extremely important that pregnant mothers not be prescribed medications that could be dangerous to the infant. It is even more important for healthcare providers and medication manufacturers to properly address the risks of certain medications and not recommend medications that could be harmful.

Many medications pose the risk of birth defects. One of the most concerning is Zofran. Zofran is commonly prescribed to individuals who are undergoing chemotherapy, who have recently undergone surgery, or who are suffering from nausea and vomiting, including pregnant women. There is some skepticism, however, about the safety of Zofran for unborn children.

Zofran Birth Defects Highlighted in Recent Lawsuit

Recently, an Illinois mother filed a lawsuit against the manufacturer of Zofran, GlaxoSmithKline, alleging that the company is aware of the risks of Zofran to unborn children but fails to properly warn patients and healthcare providers. The lawsuit claims that the when the mother was pregnant, she was prescribed Zofran, which would have been during the time that the child’s cardiac tissue was developing.

Five months after his birth, he was diagnosed with a condition called ventricular septal defect (VSD), which is a hole in the wall that separates the lower chambers of the heart. The lawsuit further states that the child is unable to run or participate in many activities, such as sports, and he also has emotional difficulties and developmental delays.

Zofran Not Approved by U.S. Food and Drug Administration (FDA)

Zofran has not been approved for use during pregnancy by the FDA, but continues to be prescribed during pregnancy for morning sickness. Further, it is alleged that GlaxoSmithKline has received at least 32 reports of an adverse reaction to the drug since 1992.

Additional research indicates conflicts in research regarding the safety of Zofran as compared to other similar medications. Questions regarding the safety of the medication have also resulted in serious inquiry into the ethics and marketing of GlaxoSmithKline. In 2012, the company settled a lawsuit filed by the U.S. Department of Justice for unlawfully promoting Zofran and for failure to report safety information for Zofran and other medications. Settlement of the lawsuit cost GlaxoSmithKline $3 billion.

There are multiple adverse reports and lawsuits targeting GlaxoSmithKline for use of Zofran during pregnancy. The FDA announced in 2011 that there was an “ongoing safety review” of Zofran due to the possibility of abnormal heart rhythms and problems with electrical signals in the heart.

Anyone with questions about Zofran and the possible risks for birth defects should contact an attorney who is knowledgeable about birth injuries.

Related Resources

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