The United States Food and Drug Administration (FDA) has released an updated warning regarding prescription Ondansetran, which most people know as Zofran. Ondansetran is the generic name for prescription Zofran which is a 5-HT3 receptor antagonist which was initially approved by the Food and Drug Administration for the treatment of nausea and vomiting specifically related to chemotherapy treatments and surgery.
has been frequently prescribed and taken in an off-label manner (meaning that the FDA did not approve Zofran to be taken specifically in this manner) for the treatment of nausea and vomiting during pregnancy. Recent scientific studies have shown a direct association between Zofran and pregnancy and the incidence of birth defects in the infants born to mothers who took Zofran during all or part of pregnancy.
Prescription Zofran is a strong antiemetic agent which works by blocking the effects of serotonin. Zofran was initially designed by scientists to be used by patients undergoing chemotherapy. Zofran can be used to treat nausea occurring as a result of chemotherapy treatments or post operation. There is currently no drug approved by the Food and Drug Administration (FDA) for the treatment of morning sickness in the United States. Many doctors have recommended that their patients take Zofran if pregnant and experiencing morning sickness, but the use of Zofran during pregnancy has not been approved by the Food and Drug Administration (FDA).
Of primary concern to pregnant mothers who take or are considering taking Zofran is the health of their unborn infants. The risks posed to infants of pregnant mothers who take Zofran during pregnancy were first studied in a study known as Motherisk in 2004. The Zofran pregnancy study observed more than 170 women in America. The study did not provide any conclusive Zofran pregnancy risks, but experts determined that the sample size of pregnant Zofran users was too small to be conclusive.
More recently, a large study conducted in Boston at the Slone Epidemiology Center and Centers for Disease Control and Prevention (CDC) in Atlanta reported a 2-times greater risk of cleft palate (birth defect) among infants born to mothers who took Zofran during all or part of pregnancy.
Any expectant mother or woman considering getting pregnant who reads that may be alarmed at the reports that Zofran taken while pregnant may double the risk of severe birth defects. If you are pregnant and considering taking Zofran to treat morning sickness, please consult your physician to understand all the risks and potential variables involved with taking Zofran during pregnancy.
If you took Zofran (generic: ondansetron) during all or part of pregnancy and your child was born with serious heart and other birth defects then call for a Free & Confidential Zofran Lawsuit Evaluation as you and your child may have a legal right to monetary compensation for damages and injuries. There is no charge for discussing your potential Zofran lawsuit with a Board Certified Personal Injury Trial Lawyer