Nausea and vomiting are common in early pregnancy and may actually serve to protect the developing fetus. Most symptoms of so-called “morning sickness” can be managed conservatively without resorting to medication. This is important because between the years of 1980 and 2014, there were no morning sickness drugs on the market that had passed the Food and Drug Administration’s (FDA) approval process. This approval process is where drug companies must show testing that establishes both the safety and efficacy of their medication. Several previous anti-nausea drugs given to pregnant women caused severe birth defects and were taken off the market as a result.
However, when a drug is approved by the FDA for one use, doctors are free to prescribe it “off-label” for other medical conditions. GlaxoSmithKline (“GSK”) took its popular cancer drug Zofran and marketed it “off-label” for use in pregnant women to help alleviate morning sickness. In spite of the fact that drug companies are prohibited from promoting sales of their drugs for uses which were not safety tested and FDA approved, GSK marketed Zofran “off-label” to obstetricians who often prescribed it to pregnant women. Over 110,000 Zofran prescriptions are estimated to have been written to expecting mothers in 2013 alone. Doctors were not told by the drug company about the risks associated with Zofran.
It is clear that GSK put sales ahead of the safety of their customers.
Studies show that using Zofran during the first 10 weeks of pregnancy doubles a woman’s risk for having a baby with a cleft palate or heart defects. Further research on the potential harm Zofran caused to unborn children is ongoing, but both the FDA and the American College of Obstetricians and Gynecologists have cautioned against the use of Zofran during pregnancy.
The United States brought suit against GSK related to its “off-label” promotion, including the off-label promotion of Zofran for use in treating morning sickness. In 2012, GSK agreed to pay more than a billion dollars to settle the government’s claims. Now, women across the country are bringing suit against GSK on behalf of their babies who were born with cleft palates, limb deformities, and heart defects.
We at the Yost Legal Group are experienced pharmaceutical and birth injury attorneys. If you or a loved one has been seriously injured as a result of using Zofran during pregnancy, you may be entitled to compensation. Call 1-800-YOST-LAW (967-8529) for help.
There is no attorney’s fee or expense unless you recover.
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