Zofran In Pregnancy May Be Responsible For Congenital Malformations

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Once again, the multinational pharmaceutical GlaxoSmithKline (GKS) is making headlines for endangering patients by marketing its drugs Zofranfor unapproved purposes.  As per a register based nationwide cohort study, Ondansetron medication in early pregnancy may be responsible for “Congenital Malformations”. The study investigates teratogenic risks with Zofran. A “teratogen” is any exposure that can cause harm to an unborn or breastfeeding baby.

Teratogens can be alcohol, prescription/non-prescription medications, illegal drugs, vaccines, illnesses, environmental exposures, occupational exposures, or maternal autoimmune disorders. A Danish study done by Danish Researchers in 2013 engaging 600,000 births found that there was no serious risk of Zofran birth defects. Nevertheless, six months later, another study based on 900,000 births from the same registry found a 30% increased risk of Zofran birth defects overall, and a doubled risk of heart defects.

Zofran was approved by the FDA in 1991 to treat nausea and vomiting in chemotherapy, radiation and surgery patients. The medication has never been approved for the treatment of morning sickness in pregnant women. In fact, its effects have never even been studied for morning sickness in expectant mothers or their developing babies.

The drug therefore has been given an FDA rating of “Pregnancy Category B.” In recent years, doctors have been prescribing it to pregnant women suffering from morning sickness, although this use is considered “off-label,” meaning it is not FDA approved. This has led to an increased risk of birth defects.

An investigation by the Toronto Star in 2014 found that at least 20 Canadian women had reported serious Zofran side effects to the U.S. Food and Drug Administration after being prescribed Zofran for morning sickness, including two infant deaths and multiple cases of Zofran birth defects of the heart and kidneys. Based on recent Studies, Zofran Side-Effects Lawsuits Claim the medication taken During Pregnancy to treat morning sickness can lead to newborns having cleft palate, cardiac malformations and other birth defects, the FDA has cautioned against its use in pregnancy.

There are also potential maternal risks associated with taking Zofran especially in pregnant women with electrolyte imbalance due to severe nausea and vomiting.As the links between unfortunate birth defects and the use of Zofran during pregnancy become clear, the time to act is now.


As a result of GlaxoSmithKline’s failure to adequately warn about the potential Zofran side effects for unborn babies plaintiffs from all over the nation filling lawsuit against Zofran, the drug labels do not include warnings about the risk of Zofran birth defects. They are alleging the manufacturers for negligently manufacturing, selling and marketing a drug without disclosing its risks. Zofran lawsuit accuses GSK of promoting Zofran to pregnant women without receiving approval from the FDA and without conducting “a single clinical trial” in pregnant women.

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