Landing: ZOFRAN Side Effects Help


“I thought it was safe. How could something like this happen?” Many doctors continue to prescribe the anti-nausea drug Zofran® for morning sickness, despite the fact that this is an off-label use not approved by the U.S. Food and Drug Administration. If you took Zofran while pregnant and your child was born with a birth defect you could be eligible for compensation.

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What Is Zofran?

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Zofran is a drug manufactured by GlaxoSmithKline Inc. (“GSK”). GSK lists 4 uses for Zofran on its self-produced Information. ONLY THESE FOUR USES BELOW WERE APPROVED by the U.S. Food and Drug Administration:
  1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy including cisplatin ≥ 50 mg/m².
  2. Prevention of nausea and vomiting associated with initial and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
  3. 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.
  4. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patient in whom there is little expectation that nausea and/or vomiting will occur postoperatively.

Is Zofran Safe For Pregnant Women?

The FDA did not approve Zofran for use by pregnant women. This did not prevent the manufacturer, GlaxoSmithKline (GSK), from encouraging OBGYNs and doctors to prescribe the drug to pregnant women to alleviate morning sickness. GSK has to admit that Zofran (also known by its generic name, Ondansetron) was not tested for use by pregnant mothers, and states the following in its Prescribing Information: “Reproduction studies have been performed in pregnant rats and rabbits with daily oral doses up to 15 and 30 mg/kg/day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to ondansetron. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproduction studies are not always predicative of human response, this drug should be used during pregnancy only if clearly needed.”

Causing Damage: Zofran and Birth Defects

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GSK has to admit that Zofran was not tested for use by pregnant mothers, and research has suggested that exposure to Zofran during pregnancy may increase the risk that children develop birth defects or congenital malformations. Many of those babies were born with the following devastating injuries:
  • Cleft Palate: The roof of the mouth (palate) is formed between the sixth and ninth weeks of pregnancy. A cleft palate is when the tissue of the palate does not completely join together.
  • Cleft Lip: The lip forms between the fourth and seventh weeks of pregnancy. A cleft lip occurs when the lip does not completely join before birth. This causes a visible opening in the upper lip.
  • Heart Defects or Congenital Cardiac Malformations: These include heart murmurs and atrial septal defects also commonly known as a hole in the heart.
  • Other Defects: Such as being born with only one kidney are also being researched. If you took Zofran and your child was born with any significant defect we encourage you to contact us and see if Zofran may have been the cause.
Unfortunately, the FDA has not stopped Zofran or the generic form of the drug from being prescribed to pregnant women. In 2012, the U.S. Department of Justice charged GlaxoSmithKline with illegally marketing and then selling Zofran for the treatment of morning sickness, and paying kickbacks to doctors who promoted the drug for such a purpose. GlaxoSmithKline settled the case for $3 billion, but women and children continue to suffer from the company’s tactics. If you believe that the medical complications you or your child suffered happened because you took Zofran to treat morning sickness, our lawyers want to speak with you immediately.