Medical treatments such as chemotherapy, radiation and surgery often cause nausea and vomiting in patients. To prevent these side effects, the Food and Drug Administration (FDA) approved ondansetron, a drug made and sold by GlaxoSmithKline under the name Zofran, in 1991. By 2006, the year its patent expired, Zofran had become the 20th best-selling drug in the U.S.
The drug is frequently used off-label to treat nausea and morning sickness in pregnant women, and this use has been associated with serious health conditions in newborns when their mothers took the drug during the first trimester of pregnancy. Nonetheless, U.S. Zofran prescriptions for morning sickness have increased from 50,000 per month in 2008 to 110,000 per month in 2013, meaning possibly 1 million pregnant women each year put their infants at risk by taking Zofran.
FDA Warns of Dangers in Taking Zofran During Pregnancy
In 2011, the FDA recommended doctors monitor Zofran patients for imbalance of electrolytes, compounds such as calcium and potassium that help control the body’s fluid balance. Electrolyte imbalance is a particular concern for morning sickness sufferers, who may be low on key minerals because of vomiting. Zofran use in patients with electrolyte imbalance is associated with these types of heart arrhythmias:
- Cardiac output (QT) prolongation
- Torsades de pointes
- Other irregular heartbeat patterns
These conditions can be fatal to a pregnant woman and therefore have potentially devastating consequences for her child.
Numerous Studies Tie Birth Defects to Zofran
In addition to severe harm to pregnant women, Zofran has been associated with birth defects in their infants. A 2011 study by the Centers for Disease Control and Prevention and other researchers found babies born to women taking Zofran had twice the likelihood of having a cleft palate. Problems associated with this facial deformity include ear disease, and trouble speaking and eating.
Separately, a newspaper investigation of FDA adverse effects reports heart defects and kidney malformations in children born to Zofran patients. Two infants even died.
Other research has linked Zofran use in pregnant women to these side effects in their children:
- A significantly greater incidence of defects in the cardiac septum, the wall that separates the left and right sides of the heart. Related problems can include breathlessness, high blood pressure and in serious cases cyanosis, in which the skin turns blue from low blood oxygen levels.
- A 34% higher risk of birth defects. The most common were cardiac deformities with a doubling in the rate of major heart malformations.
- An increased rate of cleft palate.
- If taken in the first trimester, a greater likelihood of major birth defects.
$3 Billion Federal Settlement Includes Zofran Allegations
Use of Zofran outside FDA-approved uses caught the attention of the U.S. Department of Justice. In 2012, GlaxoSmithKline entered into a settlement with the agency over allegations it promoted the drug to treat morning sickness and bribed doctors to prescribe it for this condition. The deal, which included a guilty plea by the company to criminal charges involving other drugs, totaled $3 billion — a record amount for a health care settlement at the time.
Get Help for Zofran Personal Injury
Zofran has been associated with disastrous personal injury to newborns. If your child has suffered after the drug was taken during pregnancy, you need immediate help from Slack Davis Sanger’ pharmaceutical attorneys. Our legal staff has the in-depth experience to take you from initial consultation to trial to get you the compensation you deserve. The team also employs a full-time, on-site legal nurse consultant with thorough knowledge of patient care. You should and can address any harm related to Zofran use by calling the pharmaceutical lawyers at Slack Davis Sanger now.