Zofran has become a widely popular morning sickness treatment. Physician expectations were that the anti-nausea drug would benefit the patient, but GlaxoSmithKline, the manufacturer of Zofran, allegedly provided little information on the drug’s effect on unborn children. In numerous lawsuits, parents charge that GlaxoSmithKline failed to warn about an association between Zofran and certain very specific birth defects such as cleft palate and heart defects.
In 2012, GSK paid $3 billion to settle criminal and civil charges of unlawful behavior, which including illegally promoting the off-label use of Zofran and the withholding of safety information from the FDA in the 2002 through 2004 time period.
New studies from 2012 on demonstrate a frightening association between the pregnant mom’s ingestion of Zofran and an increase in certain birth defects. In addition to doubling the risk of congenital heart defects, studies indicate a similar increased risk of babies being born with a cleft palate.
Patient Frustration in the Face of Safer Alternatives
Based on anecdotal information from women who have been treated with Zofran and its generic, ondansetron, during pregnancy, many clinicians are not following the FDA recommendations for pregnant women. And doctors continue to prescribe Zofran to control the nausea and vomiting of pregnancy. This is happening despite the existence of other, safer alternatives for use, including both prescription anti-nausea drugs and over-the-counter antacids. An alternative drug has been specifically approved for use to control the symptoms of morning sickness, which does not carry Zofran’s risks and dangers.