Zofran birth defects

Defense Tries to Strike Fraud Allegations in Zofran Birth Defects Trial

Trial Over Alleged Zofran Birth Defects

Women who used the drug Zofran are alleged to be at higher risk of birth defects, according to recent lawsuits.

U.S. District Judge F. Dennis Saylor on April 24, ruling on a motion to dismiss, found that the suit’s marketing campaign allegations were too broad, but those “now untethered” marketing fraud allegations are still in the master complaints, GlaxoSmithKline PLC said in its bid to strike those claims.

“Striking these allegations is appropriate, given that the adequately pleaded claims — and the allegations underpinning them — define the scope of discovery,” the drugmaker said. “GSK will be significantly prejudiced if plaintiffs are permitted to obtain discovery on these inadequately pleaded allegations.”

Much of the Zofran controversy stems from the FDA discontinuation of the drug in certain cases. Zofran Oral Solution, a selective 5-HT3 receptor antagonist, is indicated for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy, including cisplatin ≥50mg/m2; prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy; prevention of nausea and vomiting associated with radiotherapy in patients receiving total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen; and prevention of post-op nausea and vomiting.

Although Zofran is not approved to treat morning sickness, it is commonly prescribed “off-label” for this purpose. In fact, it has been estimated that approximately 1 million pregnant women are prescribed Zofran each year to relieve the symptoms of morning sickness, specifically nausea and vomiting. Off-label prescribing is legal and done at the doctor’s discretion; however, when used in this capacity, Zofran has been linked to birth defects.

Birth Defect Studies

  • Hong Kong-based study published in 2006 found that Zofran readily crosses the human placenta during the 1st trimester of pregnancy. Traces of the drug were found in every sample of fetal tissue taken from 41 test subjects.
  • Epidemiological study of more than 10,000 birth records performed by researchers at Harvard and Boston University links Zofran to a 2.37-fold increased risk of cleft palate.
  • Zofran associated with a 20% increased risk of kidney defects and other congenital abnormalities in a study published in BioMed Research International.
  • In 2013, a Danish Study titled “Ondansetron use in early pregnancy and the risk of congenital malformations”found a 2-fold increased risk of heart defects in babies whose mothers used ondansetron in pregnancy.
  • June 2014 study published in the Toronto Star finds at least 20 women who took Zofran for vomiting in pregnancy had children with birth defects, including 2 infant deaths and multiple cases of heart and kidney malformations. Four of the babies weighed as little as 4.5 lbs. In 6 cases, the birth defect was characterized as “fetal growth restriction.”
  • In December 2014, Reproductive Toxicology publishes the ‘Anderson Study’ which links ondansetron use during the 1st trimester to a doubled risk for atrial and ventricular septal heart defects, collectively known as “hole in the heart” defects.
  • Medical practice guidelines advise physicians to use caution when prescribing Zofran, saying the drug should be used only after all other options for treating morning sickness have been exhausted.

If you are interested in learning more, or feel that you may have a claim for the use of Zofran, please contact us, or visit this page. Personal Injury Law Firm offers free confidential consultations.