Morning sickness is a common side effect of pregnancy. According to the American Pregnancy Association, more than 50 percent of pregnant women experience some degree of morning sickness, vomiting or nausea. This unpleasant occurrence can negatively impact day-to-day life. When seeing this opening in the market, GlaxoSmithKline began marketing Zofran as an off-label option to treat morning sickness, prompting thousands of pregnant women to begin taking the drug.
Recent research has shown, however, that Zofran has been linked to an increased risk of causing birth defects. Women who are pregnant and suffer from morning sickness should be aware of new research that links an increased risk of birth defects to Zofran.
The pharmaceutical lawyers at Simmons Hanly Conroy are currently investigating the legal rights of women who took Zofran while pregnant and whose children suffered any of the following Zofran side effects:
- Cleft lip
- Cleft palate
- Heart defects, including:
- Atrial septal defect (hole in the heart)
- Ventricular septal defects (VSD)
- Tetrology of fallot (TOF)
- Hypoplastic heart syndrome
- Renal agenesis (born with one kidney)
Zofran is an anti-nausea medication that is prescribed off-label for women during pregnancy. When it was first developed by GlaxoSmithKline in the mid-1980s, it was designed to prevent nausea and vomiting in cancer and post-surgery patients. The U.S. Food & Drug Administration approved it for this use in 1991.
From 1983 to 2013, morning sickness did not have an approved FDA treatment. The company began marketing its drug to women suffering from morning sickness and the more severe version of morning sickness called hyperemesis gravidarum.
While Zofran has been prescribed for the off-label use to treat morning sickness, the drug’s label does not list the increased risk of causing birth defects. This has led to Zofran lawsuits alleging that the drug manufacturer illegally marketed Zofran and negligently failed to warn consumers and health professionals about the actual risks of Zofran side effects during pregnancy.