A little girl in North Dakota is preparing for a risky surgery most people don’t have until much later in life all because of complications her mother claims to have been the result of Zofran.
According to a report on March 17th from Valley News Live.com, the child is scheduled to undergo an open heart surgery two months from now as a way to reverse certain issues her mother believes to have stemmed from exposure to the anti-nausea medication before birth. The now two-year-old was born with a heart twice as large as it should be, and with extra holes, which was initially discovered after an X-ray that followed a seemingly routine visit to the doctor for fever symptoms. “I thought it was just a fever and then you walk out thinking what’s wrong with my kid you know. This is heartbreaking,” her mother now remembers.
What’s even more problematic is that Zofran was not designed for use in pregnant women. Approved in 1991, the medication is only approved by the U.S. Food and Drug Administration (FDA) to treat chemotherapy, radiation and surgery patients. It has not been proven effective in treating extreme nausea in soon-to-be-mothers, which its manufacturer, GlaxoSmithKline, admitted to in the published results of an investigation last year by The Toronto Star and is mentioned in numerous Zofran lawsuits. It has only been tested on animals and certainly not on pregnant women, which a North Dakota pharmacist attributes to the FDA’s hesitance in conducting studies on this demographic. By doing so, “You’d put pregnant mothers and their children at risk,” he said.
Despite its lack of approval, women who may or may not know about Zofran problems are continuing to take the medication and may be unknowingly placing themselves at risk for having children born with birth defects. According to adverse event reports filed with GlaxoSmithKline, as well as with the U.S. Food and Drug Administration (FDA), these may include abnormalities to the heart, kidneys and brain, and result in serious problems associated with fetal development. Instances of Zofran cleft lip and palates have also been mentioned in complaint reports filed with the federal agency.