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.
The Facts Are:
Studies have shown that the use of Zofran® by pregnant women doubles the risk that their child will be born with a cleft palate and/or congestive heart failure. Simply put, the risks associated with taking Zofran® to combat symptoms of morning sickness during pregnancy far outweigh the benefits.
In 2012, drug manufacturer GlaxoSmithKline plead guilty to illegally promoting off-label use of Zofran® to physicians for treating pregnancy-related nausea, despite a total lack of proper testing. The company plead guilty to fraud charges related to the marketing of Zofran® and other drugs and paid a $3 billion fee to settle the case brought against them by the U.S Department of Justice.
If you or a loved one suffered serious injuries after taking a defective or dangerous drug, you may be entitled to compensation for your pain & suffering, medical bills and hardship. Doctors and drug manufacturers have an obligation to inform patients of all the risks associated with the medication they prescribe. When doctors and their patients are misled about the safety of a drug or medication, the manufacturer is responsible for any damages or injuries suffered by a patient.
Henson Fuerst is Here to Help
If you believe that you may have a case against the manufacturers of Zofran® or any other dangerous drug, call Henson Fuerst today at (919) 781-1107 or fill out a free consultation form online.
When you call, you will speak with one of our experienced North Carolina drug injury attorneys absolutely FREE. We will review every detail of your situation at no cost to you and fight hard to secure the maximum compensation for your injuries.
At Henson Fuerst we have extensive experience standing up to major drug manufacturers on behalf of our clients. If we take your case, you will never pay an attorney’s fee up front, and you owe us nothing unless we win your case.