Zofran® Birth Defect Cases
Zofran® (a/k/a Ondansetron), a medication that has been widely prescribed to treat morning sickness in pregnant women, has been linked to serious birth defects, including heart defects and oral clefts.
Although Zofran® is approved by the Food & Drug Administration for use in treating nausea in patients undergoing chemotherapy and radiation therapy, it has never been approved for use in treating morning sickness.
If you took Zofran® during your pregnancy and your child suffered from a birth defect, you need to know your rights. Contact Ventura Law today at 203-800-8000 for a free, confidential consultation about your case.
Zofran® Linked to Oral Clefts and Heart Defects
According to a January 2012 by the Center for Birth Defects Research and Prevention, women who took Zofran® during pregnancy had twice the risk of having a child born with a cleft lip or cleft palate, as compared to those who did not use the drug. This study, which drew from the experiences of over 9,000 women, clearly demonstrated that the medical community was aware of these concerns for years.
In August 2013, another major medical study revealed that pregnant women who were prescribed Zofran® during their first trimester were more than twice as likely to have children born with congenital heart defects, many of which were life threatening or severe.
FDA Investigates Zofran® Use in Pregnant Women
The FDA became involved in the Zofran® controversy in 2011 after noticing a shocking rise in the rate of birth defects reported by mothers using Zofran®. The FDA’s investigation found that Zofran® has never been approved by the FDA -- or proven to be safe -- for use by pregnant women, it has become one of the most commonly prescribed drugs for morning sickness in pregnancy.
Despite the fact that the manufacturer, GlaxoSmith Kline, knew that Zofran® was not approved for use in pregnant women, the company completely disregarded the safety of the public and actively promoted the drug to doctors for unapproved use. In June 2012, GlaxoSmith Kline paid the federal government over $1 billion to resolve allegations that it promoted Zofran® for unapproved, “off-label” treatment of morning sickness in pregnant women and for paying kickbacks to health care professionals to induce them to promote and prescribe this dangerous drug.
Contact Us Today if Your Child Suffered a Birth Defect from Zofran®
If you took Zofran® during pregnancy and your child developed a heart defect, oral cleft, or other significant birth defect, please call Ventura Law today at 203.800.8000 for more information. We have attorneys and intake staff standing by 24/7 to answer your questions and help you understand your rights regarding your Zofran® claim.