GlaxoSmithKline (GSK) released Zofran, also known as Zuplenz, in early 1991 for the treatment of severe nausea and vomiting related to surgeries and cancer treatments. The FDA approved the medication for this purpose, but soon after doctors found that it was also useful in reducing morning sickness in pregnant women in their first trimester. What followed was wide off-label use which resulted in tragic consequences for thousands of newborns and their parents.
Brand Names: Zofran, Zofran ODT, Zuplenz
If your child suffered a birth defect while you were on Zofran (Zuplenz ®) during the first trimester of your pregnancy, you may have a Zofran Lawsuit Claim against the manufacturer for financial compensation.
Birth Defects Associated with Zofran
Zofran can cause a range of side effects, both minor and significant, including headaches, lightheadedness, blurred vision, stomach pain, irregular heartbeat, and fainting. Some patients suffer serotonin syndrome/toxicity, and in rare instances, a severe allergic reaction may be experienced. However, none of these side effects have caused as much concern as those that have been associated with fetal development. The following are some birth defects that have been linked to Zofran use:
- Cleft lip
- Cleft palate
- Cardiac Septum defects
- Ventricular Septal Defect (VSD)
- Heart murmurs and other defects
- Kidney malformations
- Atrial septal defect (a hole in the heart)
The latter two disorders are particularly serious. Craniosynostosis involves the premature fusion of the skull. A fetus’ skull is not fully enclosed by bone until after birth. Instead, fibrous sutures stretch across open portions of the skull. This is to accommodate the development of the brain. In craniosynostosis, these sutures ossify (turn into bone). The result is that the brain cannot develop fully, and the head and face misshapen. A significant reduction in IQ occurs. An atrial septal defect is a defect of the heart in which a hole is present in the dividing wall between chambers, the interatrial septum. Blood thereby flows between chambers, causing a possible diminishment of oxygen in the blood supply as it travels to the brain, organs, and tissues.
Zofran and NVP
Nausea and vomiting (NVP) is a considerable problem for first trimester pregnancies. As many as 80% of women suffer this malady during the first months they are pregnant. A few medications have been found to be effective in treating NVP, and one can imagine they are very popular and sought after. Because Zofran (generic ondansetron) has been linked to birth defects, a study was conducted (National Birth Defects Prevention Study) in 2011 to determine whether this link is founded and whether other drugs used in treating NVP might also be causal factors in birth defects. The findings were that, firstly, a patient with NVP is not more likely to give birth to an infant with these defects. Secondly, the use of several drugs did show a substantial increase in birth defects, including Zofran.
What Is Off-Label Use?
Off-label use refers to the prescribing of a drug for purposes other than what was intended. There is nothing illegal about off-label prescribing of medications, and in fact, this happens routinely when a drug that was formulated for one purpose is found to be effective for other conditions. What is illegal is advertising a drug for off-label use. The reason why the FDA prohibits such promotion is that, while rigorous testing is required to gain their approval for use of a drug as it was intended, no such testing occurs when it is prescribed for an off-label purpose.
Zofran was never approved for pregnant women suffering from morning sickness or nausea. Zofran was only approved by the FDA to treat vomiting and nausea for chemotherapy and postoperative surgery patients. Without FDA approval, GlaxoSmithKline promoted Zofran and other medications for off-label uses. GSK began to market and sell Zofran to the public and to physicians for off-label use to treat pregnant women with morning sickness. On July 2, 2012, GSK agreed to pay $3 billion to the United States Department of Justice for illegally promoting prescription medications including kickbacks to doctors who prescribed Zofran.
The Zofran Birth Defect Lawyers of Nadrich & Cohen, LLP are currently investigating claims of birth injuries, where a pregnant woman used Zofran or Zuplenz during her first trimester. If you believe that you or a loved one has a claim, contact us immediately for a free Zofran Lawsuit Claim evaluation. Call us at 1-800-718-4658, use the live chat or complete the “Do I Have A Case?” Form on this page. Don’t wait, call now to learn more about your rights.
Studies and Statistics
GlaxoSmithKline has denied that their product causes these birth defects. This denial is in the face of a growing number of studies that confirm that Zofran is dangerous for use in pregnant women suffering from nausea and vomiting. The following is a sampling of some of these trials and their findings:
- The National Institute of Health in 2011 reported a possible link between infants born with cleft palate and use of Zofran while pregnant.
- The Centers for Disease Control found this increase in the cleft palate with Zofran use to be doubled.
- The Journal of Obstetrics and Gynecology reported on a study out of Denmark that determined a 30% increase in risk for newborns to suffer severe congenital malformations.
- A report in 2014 showed that among participants in a Canadian study, more than 20 cases of serious birth defects occurred. Included were two deaths of infants, as well as kidney malformations and heart defects.
Lawsuits Related to Zofran Use
Morning sickness is a miserable experience, and it is understandable that women suffering from nausea and vomiting related to a pregnancy would seek a medical remedy. Unfortunately, treatment with Zofran, while effective in relieving these symptoms, has led to disastrous consequences for thousands of parents and their newborns. If you have been treated with this medication and your newborn has suffered consequent birth defects, you do have legal recourse. You may be able to gain compensation for costs related to medical treatment of your child, surgeries, pain and suffering, and more.
It is very important that you work with an attorney who will fight for you. Call The Law Offices of Nadrich & Cohen, LLP today to arrange a free consultation. We will fight on behalf of your child and your family to obtain maximum compensation. Please call us today for a free, confidential consultation. Your information will never be sent or shared with any third party. Please pick up the phone and call us at 1-800-718-4658 or fill out our free consultation form on the right. There is no charge for our services unless we obtain a recovery.