ACOG Endorses Off-Label Use of Zofran for Morning Sickness, Despite Birth Defects Lawsuits
A prominent medical group has endorsed the use of Zofran for morning sickness, even though the U.S. Food & Drug Administration (FDA) has never approved the anti-nausea medication for this purpose. And while a growing number of Zofran lawsuits claim that the drug increases the risk of birth defects when used by pregnant women, the American College of Obstetricians and Gynecologists (ACOG) says it is unconvinced that a causal link exists.
Zofran (ondansetron) has been available since 1993, and is currently approved to treat nausea and vomiting related to surgery or certain cancer treatments. However, according to RXInjuryHelp.com, the medication has long been used off-label to treat women who are experiencing nausea and vomiting related to pregnancy. The FDA currently classifies Zofran in Pregnancy Category B, which indicates that its effects on a developing pregnancy have not been well studied.
According to recommendations published by the ACOG last month in Obstetrics & Gynecology, morning sickness that occurs in early pregnancy should be treated, so as to prevent it from progressing to hyperemesis gravidarum, a far more serious condition.
“Recent studies have provided conflicting findings on the safety of ondansetron during pregnancy,” the group wrote. “It is the authors’ opinion that current data do not support a reluctance to treat women with ondansetron in clinical practice.”
Zofran Birth Defects Litigation
Court documents indicate that more than 260 Zofran lawsuits have been filed in federal court on behalf of children who allegedly developed serious birth defects due to prenatal exposure to the drug. The complaints point to a number of studies that suggest a link between Zofran and birth defects, including a 2014 Danish analysis of more than 900,000 pregnancies that indicated children may be two to four times more likely to suffer a septal heart defect following Zofran exposure. Plaintiffs also claim that GlaxoSmithKline has received hundreds of reports linking Zofran to congenital abnormalities, but concealed this information and failed to provide proper warnings about this risk to patients and doctors.
Finally, plaintiffs accuse Glaxo of improperly promoting Zofran as a safe and effective treatment for pregnancy-related nausea and vomiting, even though the drug has never been approved for this purpose. The complaints point out that the company agreed to pay $3 billion in 2012 in order to resolve federal charges involving the marketing of some of its medications, including Zofran. Among other things, federal prosecutors charged that Glaxo had illegally marketed Zofran for use in pregnant women suffering from morning sickness.
Bernstein Liebhard LLP offers free legal reviews to families who are interested filing a Zofran lawsuit for birth defects. To learn more, please call 877-779-1414 to schedule a free legal review with one of our attorneys.