Zofran (ondansetron) is a prescription nausea medication manufactured by GlaxoSmithKline that was prescribed by some doctors as a treatment for severe morning sickness. Zofran is under scrutiny for increasing risk of serious birth defects including cleft lip, cleft palate, mouth deformities and congenital heart defects.
The drug was approved by the U.S. Food and Drug Administration (FDA) as a medication for patients suffering nausea and vomiting caused by chemotherapy treatments, radiation therapy and surgery. It never received FDA approval for the treatment of morning sickness during pregnancy.
Zofran Manufacturer Paid $3 Billion in Settlement
In 2012, GlaxoSmithKline, the manufacturer of Zofran, paid $3 billion in settlements to the federal government and state governments after admitting to having promoted the “off-label” use of the drug to resolve morning sickness in expectant mothers, as well as for violations related to several other drugs the company manufactured and marketed, according to a U.S. Department of Justice news release.
The settlement does not affect individuals’ rights to compensation for birth injuries related to the use of Zofran during pregnancy.
If you took Zofran for morning sickness and your baby was born with a cleft palate, cleft lip or congenital heart disease, you may be entitled to compensation. Joye Law Firm represents the families of injured children in drug injury cases throughout South Carolina.
Cautions About Zofran for Pregnant Women
The FDA has cautioned against prescribing Zofran to pregnant women. An October 2013 article in ObGyn News revealed concerns about the use of Zofran by pregnant women and the increased risk of potentially fatal heart defects in babies, as well as an increased risk of serotonin syndrome, (symptoms include agitation, restlessness, confusion, neuromuscular changes, rapid heart rate and high blood pressure) which can be harmful to both mother and child.
Nausea and vomiting are common symptoms experienced in pregnancy. Expectant mothers have sought help from their physicians, and in some cases, were prescribed Zofran for morning sickness – an “off-label” use of the drug. The high incidence of birth defects in children whose mothers were prescribed Zofran may be directly associated with the drug and the manufacturer may be held responsible. Patients must be warned against potential side effects. Since the drug was prescribed off-label, pregnant women were not warned that the use of the medication could harm the baby.
Birth defects related to Zofran use may include:
- Heart defects – A heart defect can have serious consequences for a baby. Once the defect is discovered, the child may need one or more surgeries to attempt to repair the abnormality. Zofran is believed to be associated with an increased risk of ventricular septal defects, or holes in the heart wall. If not repaired, the baby is at risk of complications, including the potential loss of life, as the heart cannot function properly and must work much harder than normal. The baby may have symptoms such as shortness of breath, fast or very heavy breathing, failure to gain weight as he or she should, and other indications. If any symptoms are present and the mother took Zofran while pregnant, the baby should undergo testing for ventricular septal defects. Zofran may also be associated with heart defects such as:
- Heart murmurs.
- Transposition of arteries.
- Atrial septal defects.
- Cleft lip – The baby’s head forms in the early stages of pregnancy, between the fourth and seventh week. A cleft lip occurs when the tissues forming the lip do not fully join prior to birth. The opening in the lip may be small or can be more pronounced, with the opening going through the lip area and extending into the nose. The child will often have trouble with feeding and later with speaking clearly.
- Cleft palate – The palate, (upper roof of the mouth) is formed early in gestation, between the sixth and ninth week. If the tissue making up the mouth structure does not form correctly, it will not join together. Some babies have both the front and the back parts of their palate remaining open, while others may only have a part of the palate left open. Some affected children have hearing problems or dental problems. Surgery to repair a cleft palate takes place early in the child’s life, and further procedures will be required as they get older.
- Other serious birth defects – There is also evidence that Zofran may be associated with defects such as:
- Kidney failure.
- Cranial (skull) malformation.
- Organ malformation or malposition.
- Club foot.
Legal Action Over Birth Defects Caused by Zofran
If you were prescribed Zofran for nausea during pregnancy and your baby suffered serious birth defects, our law firm would like to speak with you. We may be able to help.
At Joye Law Firm, we are dedicated to our clients and our community. If your child has been seriously injured by a dangerous prescription drug, you can trust our South Carolina drug injury attorneys to treat you with respect and work to get the compensation you deserve. Just Call Joye Law Firm now or fill out our online contact form for a free and confidential consultation and claim review.
- FDA: Zofran Prescribing Information
- FDA: Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between January– March 2013
- Fertility Centers of New England: FDA Warns Against Zofran Use in Pregnancy
- ObGyn News: Ondansetron, New and Troubling Data
- Birth Defects Research Part A: Clinical and Molecular Teratology: Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects
- S. Department of Justice: GlaxoSmithKline to Plead Guilty And Pay $3 Billion
- CDC: Facts About Cleft Lip and Cleft Palate