With concerns about possible Zofran birth defects on the rise, many expectant mothers will be relieved to know that there is another way to alleviate the nausea and vomiting often associated with pregnancy.
In 2013, the U.S. Food & Drug Administration (FDA) approved Diclegis as a treatment for pregnancy-related gastric distress, and placed the drug in Pregnancy Category A, the best possible rating. Category A designation indicates that adequate and well-controlled studies have not shown that Diclegis poses any risk to a developing fetus during the first trimester of pregnancy.
Zofran and generic versions of ondansetron have long been used to treat pregnant women suffering from nausea and vomiting, but the drug has never been approved by the FDA for this use. In fact, Zofran is classified as Pregnancy Category B, which indicates its effects on a developing fetus have not been well studied. Last month, at least two Zofran lawsuits were filed in U.S. courts on behalf of children who allegedly suffered serious heart birth defects after their mothers had been prescribed the medication to treat nausea and vomiting during their pregnancies.
Both Zofran birth defect cases accuse GlaxoSmithKline of illegally promoting the anti-nausea medication as a treatment for pregnancy-related nausea and vomiting. The plaintiffs point out that in 2012, the drug maker agreed to pay $3 billion to settle charges brought by the U.S. Department of Justice that it had illegally marketed Zofran and other drugs. Among other things, federal prosecutors accused the company of promoting Zofran as a treatment for morning sickness.
The Zofran lawsuits also claim that Glaxo concealed data from early animal studies that suggested the drug could cross the placental barrier. The plaintiffs further assert that since 1992, the company has received over 200 reports of babies born with possible Zofran heart defects and other problems, but concealed this information from healthcare providers and consumers. “These reports included congenital heart disease, dysmorphism, intrauterine death, stillbirth, kidney malformations, congenital diaphragmatic anomaly, congenital musculoskeletal anomalies, and orofacial anomalies, among others,” the complaints state.
If you believe your baby was the victim of a Zofran birth defect, there is help available. Our attorneys are investigating potential legal action on behalf of children who may have been harmed due to pre-natal exposure to Zofran, and they can review your case at no cost or obligation to you. To learn more about filing a Zofran lawsuit on behalf of your child, please call to schedule your consultation.