Tell your Review our Calling this number connects you with a Drugwatch representative. Skip the missed dose if it is almost time for your next scheduled dose. But the US Food & Drug Administration never approved Zofran, or its active ingredient ondansetron, for use during pregnancy. Call your doctor for medical Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, The study concluded, “Ondansetron taken during pregnancy was not associated with a significantly increased risk of adverse fetal outcomes.”The second study by Dr. Andersen, using data from the same sources but from 1997 to 2010, “found a doubling in the prevalence of major congenital heart defects in children whose mothers redeemed a prescription of ondansetron in the first trimester of pregnancy.” The study cited in particular failures of the heart to form properly called atrial septal defects, ventricular septal defects and atrioventricular septal defects.A 2014 review article by Dr. Gideon Koren published in American Journal of Obstetrics and Gynecology highlights the risks of pregnant women taking Zofran and conflicting studies that cannot rule out dangers to a fetus. 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Dr. Koren highlights a study by Dr. Andersen that was published in August 2013 and found a “2-fold increased risk of cardiac malformations with ondansetron (Zofran), leading to an overall 30 percent increased risk of major congenital malformations.” The study by Dr. Andersen was based on data from the Danish Birth Registry (including over 800,000 pregnant women) collected between 2004 and 2011.A different 2013 study by Dr. Colvin, which looked at birth records in Western Australia between 2002 and 2005, “did not detect any adverse outcomes from the use of ondansetron in pregnancy but could not conclude that ondansetron is safe to use in pregnancy.” While “the study was too small to assess risks of individual birth defects” (only 251 births associated with the drug out of almost 97,000 births total) the researchers found a six-fold increase in the risk for kidney malformations associated with ondansetron.Results of the latest study of ondansetron use for hyperemesis gravidarum (HG), published in 2016, contradicted many of the earlier studies. As a result, GlaxoSmithKline removed the 32 mg, single intravenous dose from the drug’s label.The updated label said the drug could be used in adults and children with chemotherapy-induced nausea and vomiting at a dose of 0.15 mg/kg administered every four to eight hours for three doses; however, no single intravenous dose should exceed 16 mg.In December 2012, the FDA notified health care professionals that the 32 mg, single intravenous dose of Zofran would no longer be marketed because of the potential for serious cardiac risks. The FDA said in its Drug Safety Communication that it was working with the manufacturers of all 32 mg dose ondansetron injectable products (brand and generic) to recall them from the market. Common side effects of the drug are headaches and sometimes constipation.The drug has not yet been approved by the FDA for its use during pregnancy and is prescribed off label, but with the latest findings, women should feel safer reaching for the drug. In 2015, MonoSol Rx developed a closely related drug, Zuplenz, and first sold it in October 2010. Call your doctor for medical advice about side effects. Zofran (with active ingredient ondansetron) is an antiemetic medication, which means it is used to prevent vomiting. However, authors recommended “continued surveillance” of the effects of this drug on the fetus during pregnancy.A 2014 study in the American Journal of Obstetrics & Gynecology says 97.7 percent of prescriptions for the treatment of nausea and vomiting in pregnancy in the U.S. “are with medications not labeled for use in pregnancy, not indicated for nausea and vomiting in pregnancy, and not classified as safe in pregnancy by the Food and Drug Administration.” That group includes Zofran, Zuplenz and ondansetron.As an alternative, those with morning sickness can turn to a combination of doxylamine and pyridoxine, which the FDA approved in 2013 specifically to treat nausea and vomiting in pregnancy.