Zofran, as well as the generic versions of ondansetron, have been approved by the Food and Drug Administration for the treatment of vomiting and nausea that is caused by radiation and chemotherapy. However, it has also been prescribed to pregnant women for the “off-label” use to treat nausea caused by morning sickness. Unfortunately, studies have shown that it may be unsafe for pregnant women to take Zofran, especially during their first trimester, due to risk of injury to your baby. Zofran can be transmitted to the fetus through the placenta.
What is Zofran?
Zofran, manufactured by GlaxoSmithKline, is in a class of drugs known as 5-HT3 receptor antagonists. These drugs are typically used to block the action of serotonin (a naturally produced chemical in the body) that may cause nausea and vomiting. Although it is often prescribed to treat morning sickness in pregnant women, it has not been approved to treat morning sickness. Zofran can be administered as an oral solution, a pill or as an injection. Both Zofran and the generic version ondansetron was approved by the FDA (Food and Drug Administration) in 1991, but only for the uses of post-cancer treatment related nausea and vomiting.
What Are The Birth Defect Risks?
Taking Zofran during the first trimester of pregnancy means the drug can enter the placenta and pose a risk of injury to the fetus. Medical studies have raised concerns about the risk of birth defects and/or malformations when Zofran is taken for morning sickness. Some birth defects or malformations could include:
• Congenital heart defects
• Musculoskeletal anomalies
• Cleft lip
• Cleft palate
• Club foot
• Neural tube defects
• Pulmonary atresia
• Pulmonary stenosis
• Spina Bifida
• Kidney failure
• Malformed kidneys
The use of Zofran may also be linked to a risk of serious and potentially life-threatening heart complications for users, including pregnant women and possibly their unborn babies. Zofran continues to be prescribed to expectant mothers to treat morning sickness and although it may relieve the symptoms of nausea and vomiting, users should be aware of the potential risks involved.
If you took Zofran during pregnancy and your baby developed a birth defect or malformation, you may be entitled to compensation for injuries sustained. The attorneys at Springer & Lyle offer free consultations to discuss the merits of your case and time limits on when cases must be filed.