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Facts about Zofran-related Birth Defects

Zofran, a drug originally approved for the treatment of nausea and vomiting as a result of chemotherapy, radiation therapy, and surgery, is at the center of increasing public scrutiny for its off-label use. Doctors have been prescribing the drug to treat nausea and vomiting resulting from morning sickness during pregnancy. Zofran has never been approved for this use, and has resulted in dangerous side effects for pregnant women and their babies. If were prescribed Zofran during pregnancy and your baby was born with a birth defect, the attorneys at Goldstein & Hayes, P.C. can help. Contact us today to discuss your case.

Zofran is Not Approved by the FDA for Treatment of Pregnancy-Induced Nausea

In fact, Zofran is not FDA approved at all for prescription during pregnancy. The drug is currently still being investigated by the FDA to determine the risks and dangers associated with taking the drug while pregnant. GlaxoSmithKline, the manufacturer of Zofran, marketed the drug to doctors for the treatment of pregnancy-induced nausea even though the dangers of taking the drug during pregnancy had not been fully evaluated. GlaxoSmithKline has admitted to some negligence in its promotion of Zofran. In 2012, the company was sued by the U.S. Department of Justice, and agreed to pay a settlement of $3 billion. The U.S. Department of Justice alleged that among other things, GlaxoSmithKline illegally promoted off-label uses of the drug, and also had bribed health care professionals to prescribe Zofran.

A Number of Studies Have Confirmed a Connection Between Taking Zofran During Pregnancy and Increased Risk of Birth Defects

A number of reputable studies have demonstrated the connection between Zofran and birth defects. Studies have found that taking Zofran while pregnancy can result in:

  • A 30% increased risk of heart defects

  • A doubled risk of babies developing cleft lip and cleft palate

  • Club foot

  • Skull deformities

  • Jaundice

  • An increased risk of kidney malformations

Doctors are still prescribing Zofran to pregnant women today. Approximately one million pregnant women were prescribed Zofran for the treatment of morning sickness in 2014.

Many Women Have Initiated Lawsuits Against GlaxoSmithKline to Hold the Company Accountable

A number of women are holding GlaxoSmithKline responsible for its illegal marketing of Zofran. Lawsuits are alleging that the company failed to test the safety of prescribing Zofran during pregnancy and when the risks and dangers became apparent, failing to disclose those risks. If your family is among those impacted by Zofran, you should know you are not alone. You can turn to our experienced Atlanta injury attorneys for help. We are experienced in fighting for families, particularly in litigation involving birth defects or dangerous drug prescriptions.