Zofran FDA Resources, Studies and Updates

FDA Resources & Studies

FDA Zofran Information

Is ondansetron safe for use during pregnancy? was published in the October 2012 issue of Canadian Family Physician and stated that, “Because the paramount challenge of treating pregnant women with medications is fetal and maternal safety, ondansetron should be used cautiously only after drugs with better safety records that have been labeled for use in pregnancy (eg, doxylamine-pyridoxine) have been tried.”

The January 2012 issue of Birth Defects Research Part A: Clinical and Molecular Teratology published the study, Medications Used to Treat Nausea and Vomiting of Pregnancy and the Risk of Selected Birth Defects concluded that, “Nausea and vomiting of pregnancy was not observed to be associated with an increased risk of birth defects, but possible risks related to three treatments (i.e. proton pump inhibitors, steroids and ondansetron), which could be chance findings, warrant further investigation.”

In December of 2014, Dr. Gideon Koren published his findings and concerns regarding Maternal safety concerns regarding ondansetron (Zofran) in the article, Treating morning sickness in the United States—changes in prescribing are needed, in the American Journal of Obstetrics and Gynecology. The study of 900,000 Danish women found a “2-fold increased risk of cardiac malformations with ondansetron (Zofran), leading to an overall 30 percent increased risk of major congenital malformations.”

Aarhus University’s Department of Clinical Medicine published, Ondansetron use in early pregnancy and the risk of congenital malformations –a register based nationwide cohort study in 2012 and “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.”

Updates

Judge Saylor Denies Motion to Dismiss Zofran Lawsuits

Judge Dennis F. Saylor, IV, the federal judge overseeing the Zofran multidistrict litigation (MDL 2657) in the District of Massachusetts denied GSK’s request to dismiss complaints, ruling instead that litigation should proceed to the discovery phase, noting “The plaintiffs [should be given] some opportunity to develop the facts, whatever those facts may be.”
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