Zofran is a drug for used to address nausea after chemotherapy, radiation, or surgery to prevent or limit vomiting. A common off-label use is the treatment for morning sickness in pregnant women. Sadly, this particular use has been linked to birth defects in the children of the mothers treated with Zofran. Multiple studies have found a correlation between the drug and birth defects and is presently the subject of litigation.
Zofran’s manufacturer, GlaxoSmithKline, actively marketed the drug for the off-label use as a safe and effective treatment for routine morning sickness in pregnant women. However, a 2011 study completed with money from the CDC reported that Zofran doubled the rates of birth defects in mothers taking the drug. Studies have shown that the risk of cleft palate increases by 2.4 times, and the risk of heart defects doubled in women using Zofran during pregnancy.
In 2012, Zofran’s manufacturer pled guilty to criminal charges filed by the United States Department of Justice for its off-label marketing of Zofran for uses it was never approved for by the FDA. It has also been part of a multi-medication settlement regarding off-label marketing in which GlaxoSmithKline payed $3 billion.
Recently, a federal judge declined to dismiss hundreds of lawsuits related to Zofran’s off-label marketing as an anti-nausea medication for use in pregnancy. In so ruling, the Judge was skeptical of the manufacturer’s compliance with FDA regulations.
If you or a loved one has a child born with a birth defect and took Zofran for morning sickness during pregnancy, contact the experienced product liability attorneys at Neumann Law Group for a free consultation.