As many as 90% of pregnant women experience some nausea during the early stages of pregnancy, and a small percentage of those women will experience vomiting during pregnancy that is so excessive it may result in dehydration, weight loss and other complications. Some of these women may seek help from the anti-nausea medication Zofran, marketed by GlaxoSmithKline “off-label” as a treatment for morning sickness, without realizing that the drug has never been approved as a morning sickness treatment, and may actually put their unborn baby at risk for severe birth defects. If you took Zofran during pregnancy and your child was born with a congenital malformation like cleft lip, cleft palate or a heart birth defect, contact a knowledgeable Zofran lawyer today for legal help.
Zofran Not Approved for Use in Pregnancy
Zofran (ondansetron) was approved by the U.S. Food and Drug Administration (FDA) in 1991, as a treatment for nausea and vomiting among patients undergoing surgery or chemotherapy treatment. However, shortly after Zofran became available for consumer use, GlaxoSmithKline saw a whole new market for Zofran – pregnant women experiencing a severe form of morning sickness called hyperemesis gravidarum. This is despite the fact that Zofran has never been approved by the FDA for this use, nor has it been tested to determine whether Zofran is safe or effective for use during pregnancy. In fact, a growing number of studies have indicated that pregnant women who take Zofran may actually have a higher risk of giving birth to babies with serious birth defects.
Risk of Birth Defects from Zofran
One of the first studies to identify a potential connection between Zofran and birth defects in babies was conducted by researchers from Hong Kong and published in 2006. According to the findings of the study, Zofran is capable of crossing the human placenta in significant amounts when taken by pregnant women, and may interrupt the development of an unborn baby. Several other studies have examined the risk of birth defects allegedly associated with Zofran use in pregnancy, including research published in the journal Reproductive Toxicology in December 2014, which found that Zofran use during the first trimester of pregnancy doubled the risk of “hole in the heart” birth defects in babies, and increased the overall risk of birth defects by 62%.
Zofran Birth Defect Lawsuits
As more and more people across the United States become aware of the potential for Zofran use in pregnancy to cause serious birth defects, parents whose children were born with severe congenital malformations after being exposed to the anti-nausea drug in utero are pursuing legal claims against GlaxoSmithKline. All of the Zofran birth defect lawsuits involve similar allegations that the drug manufacturing company designed a defective medication, illegally marketed Zofran for unapproved uses, and failed to provide adequate warnings to consumers and the medical community about the alleged risk of Zofran birth defects in babies.
A Reputable Zofran Birth Defect Attorney Can Help
Court documents that have emerged in this new wave of Zofran lawsuits indicate that GlaxoSmithKline may have known as early as 1992 that Zofran was capable of posing an “unreasonable risk of harm” for unborn babies in the womb. If your child was born with a “hole in the heart” birth defect or another severe congenital malformation, and you believe Zofran to be the cause, consult an experienced Zofran attorney to discuss your legal options. You may have grounds to file a Zofran birth defect lawsuit against GlaxoSmithKline, in order to pursue the financial compensation you deserve for your child’s injuries, past and future medical bills, and emotional trauma.