Zofran® (ondansetron) was approved for use by the Food and Drug Administration (FDA) in 1991. The intended use of Zofran® was to combat nausea and vomiting caused by chemotherapy treatment or the residual effects of anesthesia after surgery.
Despite a complete lack of clinical trials, Zofran® was prescribed to expectant mothers to help combat morning sickness during the first three months of pregnancy. When patients take a drug to treat a condition other than the one for which it was originally approved by the FDA, it is known as “off-label” usage.
Tragically, the off-label use of Zofran® by pregnant women has been linked to severe birth injuries.
If you or a loved one took Zofran® during pregnancy and your child experienced any type of medical conditions at birth, you may be entitled to significant compensation.
Zofran® Not FDA Approved For Use by Pregnant Women
Zofran® was never approved by the FDA for use in pregnant women, yet this did not prevent the drug’s manufacturer, GlaxoSmithKline, from capitalizing on the lack of FDA-approved morning sickness drugs on the market. GlaxoSmithKline promoted the benefits of Zofran® as a morning sickness medication to doctors and patients despite a lack of proper testing.
In most women, the symptoms of morning sickness are most acute during the first the trimester of pregnancy. This first trimester is also the most crucial to a baby’s development.
The use of Zofran® by pregnant women has now been linked to severe birth defects, including:
- Cleft palate
- Cleft lip
- Congenital heart defects
- Born with one kidney
- Musculoskeletal abnormalities, including Spina Bifida and Club Foot
These birth injuries are devastating for new parents and their babies. These injuries can lead to a lifetime of medical care and may rob a child of the opportunity to grow into a healthy adult.