Nausea and morning sickness are very common during pregnancy, affecting an estimated 80 percent of expectant women. Many doctors have prescribed the anti-nausea drug Zofran (also known as Ondansetron) to treat nausea and morning sickness in women during pregnancy, despite ongoing concerns about serious side effects including heart defects and cleft palates in infants.
The Food and Drug Administration (FDA) has approved Zofran for treatment of cancer patients having nausea and vomiting during chemotherapy and radiation therapy. The use of the drug to treat severe morning sickness is an off label use. Yet more than one million pregnant women a year are exposed to Zofran and its potential side effects.
If you or someone you love took Zofran during pregnancy and your baby was born with a heart defect or cleft palate, let a drug injury attorney at Bubalo Goode review your legal options. Drug makers have a legal responsibility to make and market drugs that are safe and effective, when used as directed. They should pay when they cause harm.
Study: No Reason Pregnant Women Should Take Zofran
The Food and Drug Administration has identified a potential safety concern with Zofran and placed Zofran on its list of drugs and medical products with potentially serious issues. The FDA is continuing to evaluate the issue.
A medical study recently published in the American Journal of Obstetrics and Gynecology underscores the risks to pregnant women of taking Zofran. The study said there is no reason for women to be prescribed Zofran, a drug of unproven maternal and fetal safety, since the FDA in 2013 had approved another medication specifically to treat nausea and vomiting linked to pregnancy.
The study said the use of Zofran to treat women with morning sickness had increased from 50,000 monthly prescriptions in 2008 to 110,000 at the end of 2013, despite concerns about its effect to unborn babies and a FDA warning about serious heart rhythm abnormalities.
Heart Defects in Infants of Mothers Prescribed Zofran
A December 2014 study published in the medical journal Reproductive Toxicology found a statistically significant risk of heart defects, in particular septal defects involving a hole in the wall separating the chambers of the heart in infants born to women who had taken Zofran in early pregnancy.
Cleft Palate Syndrome in Infants of Mothers Taking Zofran
A recent large study by the Centers for Disease Control and Sloan Epidemiology Unit reported a two fold increased risk of cleft palate in babies born to women who took Zofran for nausea during the first trimester of pregnancy. Clift palate and cleft lip are birth defects that occur when a baby’s mouth does not form correctly during pregnancy. The baby may undergo one or more surgeries to address the issue.
The study included more than 9,000 women.
Heart Rhythm Abnormalities
In 2011, the FDA issued a warning that Zofran may cause changes in electrical activity in the heart and increase the risk of developing abnormal heart rhythm.
The FDA said that results of a clinical study indicated that a 32 mg single intravenous dose of Zofran may affect the electrical activity of the heart, which could cause some patients to develop an abnormal heart rhythm know as Torsades de Pointes.
GlaxoSmithKline Pays $3 Billion to Resolve Fraud Allegations
In 2012, GlaxoSmithKline LLC, the manufacturer of Zofran, agreed to plead guilty and pay $3 billion to settle civil and criminal liability related to the drug maker’s illegal marketing of certain prescription drugs including Zofran for off label uses and failure to report certain safety data, according to a press release from the U.S. Justice Department. It represented the largest health care fraud settlement in U.S. history.
The settlement covered allegations that GSK promoted Zofran for the treatment of morning sickness in pregnant women, although it was only approved for treatment of nausea in cancer patients who had undergone treatment procedures. However, the settlement did not preclude individual lawsuits by families harmed by Zofran.
Drug manufacturers have a legal responsibility to make and market drugs that are safe and effective when used as intended. They should be held accountable when their drugs harm pregnant women and their babies.
Bubalo Goode represents individuals who have harmed by prescription drugs. You may be entitled to receive compensation for your injuries and other losses, as well as for your pain and suffering.
If you took Zofran during the early months of pregnancy and your child was born with birth defects associated with this medication, then you need to have a prescription drug attorney at Bubalo Goode explain your legal options.
Contact Bubalo Goode online or by phone at 866.870.2489 for a free initial consultation about your prescription drug injury case.
American Journal of Obstetrics and Gynecology
Food and Drug Administration Adverse Drug Effects Reporting System
National Birth Defects Prevention Study
Ob.Gyn.News – 10/25/2013 Article
Drug Watch: Popular Nausea Drug May Increase Risk of Birth Defects