Zofran causing birth defects
The anti-nausea drug Zofran® (generic name ondansetron) is suspected of causing birth defects in the children of mothers who took the drug during pregnancy. It was developed by the pharmaceutical giant GlaxoSmithKlein and approved by the U.S. Food and Drug Administration (FDA) in 1991. By 2006, Zofran had become the 20th most frequently prescribed drug in the United States. Generic versions of the drug were approved in the same year.
Approved Uses of Zofran
The drug was approved to control nausea and vomiting in cancer patients receiving chemotherapy and radiation. It is also approved for patients experiencing nausea and vomiting after surgery. It has been used off-label (not approved by the FDA for a specific use) to treat gastroenteritis and morning sickness in pregnant women.
Zofran is suspected of causing birth defects in some babies whose mothers took the drug to control morning sickness. If your doctor prescribed this medication during pregnancy and your baby was born with a cleft palate or lip, heart defect or limb defect, you may be eligible for compensation. Call 1-800-ELK-OHIO or contact us online to schedule a free consultation.
Zofran continues to be prescribed despite FDA investigation
Although the drug continues to be widely prescribed for pregnant women in the first three months of pregnancy, the FDA listed the drug on its Adverse Events Reporting System in March of 2014 and continues to look into the safety of Zofran. Moreover, a study conducted by the Slone Epidemiology Center in Boston and the Centers for Disease Control and Prevention in Atlanta reported that mothers who took the generic form of Zofran were twice as likely to have babies with cleft palate. Despite this, it continues to be widely prescribed for pregnant women during the first three months of pregnancy, especially when other anti-nausea drugs were ineffective. This appears to be especially true in Canada, according to a June 25, 2014 story in the Toronto Star.
Although pharmaceutical companies cannot advertise their drugs for purposes other than those approved by the FDA, no law prevents doctors from prescribing Zofran or any drug for non-approved uses. However, doctors have a legal obligation to explain the possible risks of the medication; if they do not, they may be held liable. Patients who were prescribed this drug in the past and whose children were injured may have legal recourse as well.
Call us to learn more about a Zofran lawsuit
To discuss your options with a knowledgeable Ohio attorney, contact Elk & Elk to schedule your free consultation. Call 1-800-ELK-OHIO or use our
Zofran® is a registered trademark of GlaxoSmithKline, PLC.
Do not stop taking medications except on your doctor’s advice.