Taking the prescription medication Zofran during pregnancy can increase the risk of fetal birth defects including cleft lip, cleft palate, craniosynostosis, and heart malformations. Zofran was originally approved by the FDA in 1992 to treat nausea and vomiting in cancer patients and post-surgical patients. Since the early 1990s many doctors have prescribed Zofran to pregnant patients as an “off-label” treatment for severe morning sickness, despite the fact that Zofran has not been approved by the FDA for use during pregnancy. In 2008, 50,000 odansetron prescriptions were written each month to treat nausea and vomiting in pregnant patients. By 2013, 110,000 prescriptions were being written each month for pregnant women. Moreover, the FDA has recently issued an updated warning cautioning against the use of ondansetron (the generic name for Zofran) during pregnancy.
Research suggests that the greatest risk for birth defects associated with Zofran occurs during the first trimester of pregnancy. This is a time of rapid development for the fetus, and also the time during which many pregnant women experience most nausea and vomiting.
In a 2006 Hong-Kong based study, researchers found that Zofran passes through the placenta to a fetus when taken during the first trimester. Fetal tissue samples were taken from 41 subjects, and Zofran was found to be present in every sample.
In August, 2013, Denmark researchers published a study indicating a 30% increased risk of birth defects among patients who took Zofran during pregnancy. The risk of cardiac defects was found to be twofold.
According to the American Journal of Obstetrics and Gynecology, 97.7% of medication prescribed to treat nausea and vomiting during pregnancy is not classified as safe for pregnancy by the Food and Drug Administration (FDA). In April, 2013 the FDA approved the use of a combination of doxylamine and pyridoxine to treat nausea and vomiting in pregnancy. With safe and effective alternatives available, doctors who prescribe Zofran to treat morning sickness are unnecessarily increasing the risk of birth defects.
GlaxoSmithKline (maker of Zofran) has been hit with a number of lawsuits, both civil and federal, regarding the use of Zofran during pregnancy and the lack of safety warnings. In 2012, the drug company pled guilty and agreed to pay three billion dollars to resolve federal charges pertaining to the unlawful promotion of Zofran to treat morning sickness in pregnancy.
Women who used Zofran or its generic form, ondansetron, and whose child was born with a birth defect are urged to contact Galfand Berger online or call 1-800-222-8792. Our Philadelphia personal injury lawyers are currently investigating potential civil lawsuits regarding the use of Zofran in pregnancy. A knowledgeable personal injury attorney at Galfand Berger can help you determine your best course of legal action.