Birth Defects: Zofran & Ondansetron
Did You Take Zofran for Morning Sickness?The safety risks of Zofran are being investigated thoroughly, and various agencies are monitoring all developments. If you or a loved one took Zofran for morning sickness during pregnancy and your baby was born with a cleft palate, cleft lip, or congenital heart defect, please contact us by calling us for a confidential evaluation of your potential claim.
What is Zofran?Zofran and generic versions of ondansetron have been approved by the United States Food and Drug Administration to prevent nausea and vomiting caused by chemotherapy, radiation therapy, and surgery. It is in a class of drugs known as 5-HT3 receptor antagonists that work by blocking the action of serotonin, a natural chemical produced by the human body that can cause nausea and vomiting.
However, it is not now, nor has ever been, approved to treat morning sickness at any stage of a pregnancy.
Zofran Side Effects and Risks for BabiesThe safety of Zofran for treating morning sickness has not yet been established. The FDA has not yet found it to be safe or effective for treatment of nausea and vomiting during pregnancy. According to the official federal compendium American Hospital Formulary Service Drug Information, “there are no adequate and controlled studies to date using ondansetron in pregnant women, and the drug should be used during pregnancy only when clearly needed.” Health Canada, Canada’s regulatory authority, has required a warning to physicians that “the safety of ondansetron for use in human pregnancy has not been established” and “the use of ondansetron in pregnancy is not recommended.” A study conducted in 2012 by the U.S. Centers for Disease Control and Prevention and the Sloan Epidemiology Center at Boston University has reported that taking ondansetron in the first trimester of pregnancy can double the risk of cleft palate in newborns. This study analyzed data from 9,000 women and included information from the National Birth Defects Prevention Study. Another study conducted in Denmark between 1997 and 2010 which included all births during that period (903,207 births) found the risk for major congenital heart defects also doubled with use of Zofran to treat nausea and vomiting during the first trimester. In addition a study conducted in 2006 of 41 patients in Hong Kong showed Zofran readily crosses the human placenta in the first trimester of pregnancy and was detected in every sample of fetal tissue.
Medication History: ZofranPharmaceutical giant GlaxoSmithKline (GSK) developed ondansetron in the mid-1980s (originally marketed under the brand name Zofran). The FDA first approved Zofran in 1991. At that time and currently, its only approved uses are for chemotherapy, radiation therapy, and post-operative related nausea and vomiting. GSK’s patent expired in 2006. The FDA approved the first generic versions of ondansetron the same year. GSK continued to market and sell Zofran even after generics became available. In 2006 — the final year of GSK’s patent protection on the drug — Zofran ranked No. 20 in brand name drug sales in the U.S., with sales of $1.3 billion in the first 9 months of 2006 (80% from the U.S.). Some of these blockbuster sales resulted from prescriptions to pregnant women for morning sickness — again, a use not approved by the FDA. Between 1983 and 2013, no drug was approved for use to treat morning sickness. The drug Bendectin (pyridoxine/doxylamine) had been removed from the market in 1983, but the pyridoxine/doxylamine combination continued on the market under different brand names in Canada and elsewhere for the next thirty years.
Doctors then began prescribing off-label drugs—most commonly, Zofran — for the non-approved use of alleviating pregnancy-related nausea and vomiting.After years of studies, the FDA approved the return of the combination of pyridoxine and doxylamine under the new brand name Diclegis in 2013. So, after the approval of Diclegis for morning sickness, many doctors took their cue and approximately one million women last year were still prescribed Zofran or a generic equivalent of ondansetron.