Zofran is a medication that may be prescribed to pregnant women experiencing severe “morning sickness” symptoms including nausea and vomiting. Although Zofran, also known by its generic name, ondansetron, has proved effective in treating nausea and vomiting, recent studies have shown that it can have devastating side effects on both mother and child. Several recent findings suggest that children of mothers who have taken Zofran during their pregnancy may suffer from severe birth defects.
Potential Side Effects
A recent study conducted in Denmark found that women who took Zofran doubled their children’s risk of heart defects at birth. Researchers studied a group of more than 90,000 pregnant women who took Zofran and determined that using Zofran during a critical stage of the fetus’s development (the first trimester) can cause serious side effects. The U.S. Food and Drug Administration (FDA) determined that taking Zofran during pregnancy may potentially lead to serious birth defects.
Yet, many doctors continue to prescribe this dangerous drug. Despite potential risks, the FDA had done little to caution or stop doctors from off-label use of Zofran. The fact remains that Zofran’s main function is to treat those with cancer who suffer from nausea as a result of taking chemotherapy, radiation or other treatments. However, doctors are legally allowed to prescribe the medication as they wish. Some of the most common birth defects seen as a result of Zofran use include:
- Heart defects
- Mouth deformities such as cleft lip or cleft palate
- Musculoskeletal deformities
- Kidney malformations
- Fetal growth restriction
- Fetal death
Holding the Manufacturer Accountable
A number of birth defect lawsuits have been filed against GlaxoSmithKline, the manufacturer of Zofran. In 2012, the U.S. Department of Justice filed a lawsuit against the pharmaceutical company alleging that Glaxo was involved in promoting Zofran’s off-label use, which ended in a $3 billion settlement. At the time, the company admitted that it had not tested the drug for use in pregnant women suffering from nausea and vomiting. Still, they company did not move away from promoting the drug for this off-label use and the FDA has not yet required Glaxo to do so.
The pharmaceutical company is still benefiting from millions of dollars gained from the sales of Zofran. If your child has been affected by Zofran, it is important that you exercise your rights and hold GlaxoSmithKline accountable. If your child has birth defects because you took Zofran for morning sickness, please contact an experienced Zofran attorney and obtain more information regarding your legal rights. Drug manufacturers have a responsibility and a legal obligation to do their due diligence in testing their products and ensuring its safety and efficacy before putting them in the market. It appears that Glaxo has not done its due diligence and mothers and children are suffering as a result of their negligence.