If you were prescribed Zofran for morning sickness and your child was born with a birth defect, you may be eligible to receive compensation through a lawsuit. Attorneys are currently investigating allegations that the drug, which was never approved for use in pregnant women, can cause cleft palate, heart problems and other birth defects in newborns. It has also been alleged that the company that makes Zofran encouraged doctors to prescribe the drug for morning sickness in violation of FDA rules and regulations and failed to warn both patients and doctors about the birth defect risk associated with its drug.
GlaxoSmithKline allegedly engaged in a marketing campaign to encourage doctors to prescribe Zofran for morning sickness, even though such a use for the drug was not approved by the FDA. This practice, known as “off-label marketing,” is illegal.
Although the FDA approved Zofran to treat severe nausea and vomiting following surgery or while undergoing chemotherapy, the FDA did not approve Zofran to treat morning sickness. As such, very little is known about the drug’s effects on children developing in the womb. In recent years, researchers have discovered that taking Zofran during pregnancy is associated with an increased risk of birth defects.
In July of 2012, GlaxoSmithKline agreed to pay fines to settle allegations claiming the company: 1) promoted Zofran and several other drugs for off-label (unapproved) uses; and 2) paid kickbacks to doctors who prescribed these medications for off-label uses, though the company denies the allegations. When GlaxoSmithKline agreed to settle the lawsuit, the Department of Justice stated that the “resolution is the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company.”
Zofran may cause the following types of birth defects:
An investigation by the Toronto Star found that Canadian women who took Zofran during pregnancy experienced “serious suspected side-effects.” The investigation revealed that Zofran may have caused two infant deaths, as well as multiple cases of newborns born with heart defects and kidney malformations.
In addition, Pediatric News reported that at the August 2013 meeting of the International Society of Pharmacoepidemiology researchers presented a study finding a twofold-increased risk of congenital heart defects associated with Zofran during the first trimester of pregnancy.
Furthermore, a study released in January 2012 by the Center for Birth Defects Research and Prevention found an increased risk of cleft palate for babies exposed to Zofran during the first trimester of pregnancy.
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