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Zofran

Birth Defects Caused by Zofran?

If you or a loved one took Zofran while pregnant and subsequently gave birth to a child with birth defects, you may wish to consider your legal options.

About Zofran

The Food and Drug Administration issued a warning against Zofran (Ondansetran) due to studies showing the medication can cause birth defects when used by pregnant women in 2012. Birth defects thought to be caused by Zofran include congenital heart defects, cleft lip, and cleft palate.

Approved by the FDA in December 1992, Zofran is used to prevent nausea and vomiting in patients after they have had chemotherapy and surgery. When Zofran is taken during the first trimester of pregnancy, the risk of a cleft palate birth defect nearly doubles, according to a report by the CDC’s National Center on Birth Defects and Developmental Disabilities published in 2012. Additionally, Swedish researchers concluded Zofran usage by pregnant women increases the risk for children to be born with a hole in the heart.

GlaxoSmithKline, the manufacturers of Zofran, plead guilty to promoting Zofran as safe for treating morning sickness in pregnant women in 2012. The FDA never approved Zofran for this use and said the drug was only safe for nausea caused by chemotherapy and surgery. The manufacturer was ordered to pay a total of $3 million in criminal and civil penalties after they also plead guilty to paying doctors to prescribe the drug, according the U.S. Department of Justice.

Each year more than 120,000 babies begin life with a birth defect, many of which could be avoided if patients were properly warned of the potential side effects of pharmaceutical drugs such as Zofran.

The FDA issued a warning to Glaxo back in 1999 because the company over-exaggerated the effectiveness of Zofran while failing to warn consumers about the drug’s adverse side effects. The 32 mg dosage of Zofran was recalled in 2012 after it was discovered the drug can cause an abnormal heart rhythm that could be potentially fatal.

Cases, Settlements and Verdicts

In June 2012, GlaxoSmithKline plead guilty to federal and criminal health care fraud. GlaxoSmithKline agreed to pay $2 billion in civil charges for illegally promoting Zofran to treat morning sickness in pregnant mothers. GlaxoSmithKline also agreed to pay $1 billion in criminal charges for paying kickbacks to doctors for prescribing Zofran for off-label use. This $3 billion penalty is the largest combined federal and state health care fraud recovery in a single resolution in the history of the United States.

Zofran Key Points

  • Zofran was approved in injection form by the FDA Jan. 4, 1991
  • The pill form of Zofran was approved by the FDA Dec. 31, 1992
  • The medication was never approved to treat morning sickness
  • The FDA only approved Zofran to treat nausea caused by surgery and chemotherapy
  • The 32mg dosage was recalled in 2012 due to causing potentially fatal abnormal heart rhythms in patients

Conditions Caused By Zofran

  • Congenital heart defects
  • Atrial or ventricular septal birth defect (hole in the heart)
  • Cleft palate/cleft lip
  • Fetal growth restriction
  • Heart murmur
  • Jaundice

Understand Your Legal Options

If you or a loved one suffered conditions resulting from taking Zofran, call 1-800-529-3476 for a free and confidential consultation. Our attorneys will fight for the justice and financial compensation you deserve.



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