No Trials, but Many Tribulations over Zofran (ondansetron): Drug Safety System Putting Children In-Utero at Risk

Alabama mother Marquita Smiley began taking the generic form of anti-nausea drug Zofran (ondansetron) regularly during her first trimester to treat debilitating morning sickness—but when her son Zaidan was born with a critically underdeveloped heart, necessitating open heart surgery at just 3 days old, Marquita started to wonder whether the drug she took might have been to blame for her son’s condition. After all, the drug, manufactured by GlaxoSmithKline (“GSK”), was never FDA-approved for use in pregnant women and was even marketed “off label” to expectant mothers unaware of its potential side-effects.

Pregnant women are often excluded from clinical drug trials for obvious reasons—though according to the Centers for Disease Control, up to 90% of expectant mothers use medications even though fewer than 10% of medications have enough information to determine whether they are safe to use during pregnancy. Zofran (ondansetron) seems to be quite the case study on what a lack of prenatal drug use research can yield and how the drug safety system essentially fails pregnant mothers: women like Marquita have filed hundreds of lawsuits against GSK for allegedly knowingly putting their patients at risk. In the wake of these lawsuits, the FDA is taking a larger look at prescription drug use and pregnancy, and will issue its own draft guidance entitled “Pregnant Women in Clinical Trials — Scientific and Ethical Considerations” later this year.

Many mothers living in Alabama, and numerous other states, who took the generic version of Zofran, ondansetron, may not have the chance to sue GSK or any other drugmaker that made a brand-name version of their medication. Alabama state lawmakers have recently disallowed these types of lawsuits—Marquita filed in the fall of 2015, before the Alabama law became effective.

Attorneys at Grant & Eisenhofer represent dozens of mothers and families with claims against GSK, and serves as co-lead on the Plaintiffs’ Executive Committee in the Zofran (ondansetron) MDL litigation. If you or a loved one took Zofran (ondansetron) for morning sickness during your first trimester and your baby was born with a cleft palate or congenital heart defect, please contact us at 877-978-0169 for a confidential evaluation of your potential claim.

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