Zofran (ondansetron) is a prescription drug used for the treatment of nausea and vomiting due to cancer chemotherapy or radiation therapy. It’s also prescribed for the treatment of nausea and vomiting after surgery. As an off-label use, it’s prescribed to pregnant women to treat morning sickness, usually after other drugs have failed. The drug is recently linked to lawsuits and studies that claim it causes birth defects when prescribed to pregnant women.
Normal side effects of Zofran when used for its approved uses include diarrhea, headache, fever, lightheadedness, dizziness, drowsiness, constipation, rash, blurred vision and muscle spasms. When used for the unapproved use of treating morning sickness, the drug is unfortunately linked to the additional side effect of severe birth defects in the unborn child.
Off-Label Use vs. Approved Use
“Off-label” means using a drug for an unapproved indication, dosage, form of administration or with an unapproved age group. Using prescription drugs off-label is generally legal, but the practice can carry health risks. In the United States, physicians are free to prescribe a drug for uses other than its intended purpose if they deem it safe and effective for the patient’s ailment.
Unlike physicians, pharmaceutical companies are not allowed to promote a drug for any other purpose than it was intended without FDA approval. The FDA approved the drugmaker of Zofran, GlaxoSmithKline, to market the drug to cancer patients, but they did not approve Zofran to be targeted to pregnant woman. Lawsuits have found that Glaxo illegally promoted the drug to pregnant women and that the drugmaker has known since 1992 that it could be harmful to developing babies.
How Zofran Effects Pregnant Woman
Expectant mothers with the most severe type of morning sickness, hyperemesis gravidarum, are prescribed Zofran because the morning sickness can cause malnutrition and possibly endanger the mother and baby. While the goal is to protect the mother and unborn baby, the drug is linked to other complications including severe birth defects.
Several studies have shown that Zofran passes from the mother through the placenta in significant amounts, remaining in the fetus for longer than it stays in the mother. In recent lawsuits, birth defects mentioned have included heart defects like holes in the heart, cleft lip, cleft palate, club foot and skull deformities.
Lawsuits Against GlaxoSmithKlein
In 2012, Glaxo was involved in the largest healthcare fraud settlement in United States history and they had to pay $3 billion to the U.S. Department of Justice. The lawsuit claimed that Glaxo promoted the drug to pregnant women without FDA approval and that they received kickbacks from doctors and other healthcare professionals to promote Zofran and other Glaxo drugs.
A growing number of lawsuits have been directed toward Glaxo for Zofran induced birth defects within the last year claiming that they failed to warn the public about the dangerous side effects, produced a defective drug, advertised the drug as safe for morning sickness even though it was not approved for this use, and that they falsely claimed the drug was safe for pregnant women.
If you or somebody you know took Zofran during pregnancy and had a child with a birth defect, contact a leading Zofran lawyer immediately to protect your right to compensation for pain and suffering, medical expenses, and more.