A Zofran lawsuit has been filed in Pennsylvania federal court by a woman who alleges cardiovascular defects born to her two children who were exposed to the medication, according to court documents.

The case was filed recently in the U.S. District Court, District of Pennsylvania, recent reports indicate, and alleges serious problems that resulted from the plaintiff’s use of the anti-nausea drug during pregnancy. Her children suffered congenital heart defects and other birth defects after they were exposed in the womb, which could have been avoided if GlaxoSmithKline adequately warned women about their product’s association with Zofran birth defects, her lawsuit alleges. The manufacturer was aware of evidence that lent to the medication’s potential to harm babies whose mothers took the drug during pregnancy, according to the case, which specifically points to GlaxoSmithKline awareness that Zofran may cross the placenta. The manufacturer has also received hundreds of complaint reports from women who had children with birth defects after exposure to the medication, which has also been involved in a number of clinical trials on animals that provide little proof of its safety and effectiveness in treating pregnant women.

January Case Study Finds Zofran Heart Defects

In addition to numerous Zofran complaint reports, a case study published this past January in Pediatric Emergency Care lends evidence to its association with serious heart problems. The research looked at two children—one aged 10 and the other just 86 days old—who suffered similar fates after taking the drug for symptoms associated with gastroenteritis. Both developed faster-than-normal heart rates, became unresponsive and died. The infant was later found to have had congenital heart defects prior to his Zofran exposure.

Perhaps more important though is Zofran’s lack of federal approval for extreme morning sickness by the U.S. Food and Drug Administration (FDA).  The drug originally entered the market in 1991 as a treatment for extreme nausea in patients undergoing chemotherapy, radiation or another type of surgery, making its prescription in pregnant women an off-label use.

The recently filed Zofran lawsuit notes this absence of approval, and asserts that “Women ingested the drug because they innocently believed that Zofran was an appropriate drug for use in their circumstance.”

Call a Zofran Lawyer

Dial an attorney at our Firm for a free and confidential Zofran lawsuit evaluation if you had a child with one or more birth defects that may be associated with the anti-nausea medication. Call us directly at (877) 779-1414.

Published March 12, 2015 by