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Most expecting mothers experience at least some morning sickness. And some of those turn to anti-nausea medication to get some relief. But that can be a problem when the medication has not been approved by the Food and Drug Administration for use by pregnant women.
One study linked some birth defects to the use of Zofran (also marketed as Zuplenz or its generic ondansetron) during pregnancy, and a new round of lawsuits accuses the drug's maker, GlaxoSmithKline, of marketing the drug to pregnant women without FDA approval.
Not Its Intended Use
Zofran was designed and gained FDA approval for preventing nausea and vomiting in cancer patients undergoing chemotherapy. Currently, the FDA classifies Zofran as a Category B pregnancy drug, meaning that it has been tested safely on pregnant animals, but not on humans. While doctors are permitted to prescribe drugs for "off-label" uses, drug companies are prohibited from pushing drugs for uses that haven't been approved by the FDA.
Nevertheless, GSK allegedly pushed doctors to prescribe Zofran to pregnant women. According to one lawsuit, in the FDA ordered GlaxoSmithKline to "immediately cease distribution" of ads that "promote Zofran in a manner that is false or misleading because it lacks fair balance" back in 1999. And in 2012, GSK pleaded guilty and agreed to pay $3 billion for promoting Zofran and other drugs "in a manner that is false or misleading."
Not the First Time
Apparently, neither orders from the federal government nor the largest health care settlement in U.S. could deter GSK. Deanna Brown claims her 8-year-old daughter was born with congenital band syndrome and teratologic clubfoot because she used Zofran during her first trimester. Her lawsuit also alleges she was never warned about the drug's possible side effects.
Brown's is just one of many Zofran-related product liability lawsuits that have been consolidated into one piece of litigation in a US District Court in Massachusetts. The lawsuits all claim that GSK impermissibly marketed Zofran to doctors and pregnant women while failing to provide adequate warnings about the drug.
If you or your child has been injured from Zofran use while you were pregnant, you may want to consult with an experienced personal injury attorney today.