Zofran is an anti-nausea drug which has been widely marketed to pregnant women as a morning sickness remedy. Lawsuits are being filed against the manufacturer, GlaxoSmithKline, alleging that they concealed their knowledge that the drug could cause serious birth defects and marketed the drug to pregnant women without approval from the FDA.
80 percent of women suffer from nausea or vomiting during their pregnancy, often referred to as “morning sickness”. This can become quite severe, so several women turned to Zofran to keep themselves and their babies safe. Instead, the babies suffered from severe birth defects that would have a profound impact on their future.
Birth defects that have been linked to Zofran include:
- Heart defects (holes in the heart)
- Cleft lip
- Cleft palate
- Club foot
- Craniosynostosis (skull deformities)
The legal claims brought against Glaxo center around the cause of birth defects and whether the drugmaker is liable for injuries that were suffered by babies whose mothers took the drug. Prior to getting FDA approval, GSK had not conducted any studies on the effects of the drug on pregnant women.
In 1992, GSK began receiving adverse reaction reports of birth defects which were associated with Zofran. However, GSK never disclosed these reports to pregnant women or their physicians. There have also been medical studies which have proven a link between an increased risk of a baby being born with birth defects when the mother has taken Zofran.
Pregnant women would never have taken Zofran if they had known of the danger to their unborn child. However, we wonder if GSK didn’t want women to know because it it would have decreased their profits from the sale of Zofran.
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