Zofran Lawsuits


Morning sickness during pregnancy occurs in up to 80% of pregnant women. It is most prevalent early in pregnancy, usually starting at approximately 4-9 weeks, and peaks at approximately 7-12 weeks. In most cases, nausea during pregnancy ceases by approximately 16 weeks, or in the beginning of the second trimester. While the incidents of morning sickness in pregnant women is common, until April 2013, there were no drugs approved by the FDA explicitly to deal with morning sickness during pregnancy.

It is estimated that currently, 97.7% of prescriptions for the treatment of morning sickness during pregnancy in the United States are with medications that are not actually approved by the FDA for use in pregnancy. In fact, not only are they not labeled for use during pregnancy, they are not indicated for nausea and vomiting during pregnancy, and are not classified as safe in pregnancy (commonly referred to as FDA category A). The use of Zofran, or Ondansetron for the treatment of morning sickness during pregnancy has steadily increased from 50,000 prescriptions per month in 2008 to 110,000 prescriptions per month at the end of 2013. What this means is that around one million pregnancy women are exposed to Zofran or Ondansetron out of four million pregnancies per year.

Zofran, or in its generic name Ondansetron, is a 5-HT3 receptor antagonist blocking the effect of Serotonin, which was designed originally for cancer chemotherapy induced nausea and vomiting. Zofran is also labeled for use for nausea and vomiting associated with radiation therapy, anesthesia, and surgery.

Given its success with reducing nausea and vomiting in patients such as chemotherapy treatment, the “off label” promotion of Zofran for use in pregnant women has slowly increased, despite the fact that the Zofran side effects with respect to use by pregnant women is currently vastly understudied. Zofran side effects, even to today’s date, have been woefully understudied and examined. This is despite the fact that the use of Zofran by pregnant women goes up nearly every year.

There have been several studies examining the potential Zofran side effects throughout the years. The first Zofran side effect study on record was from 2004, which could not detect an increased Zofran side effect teratogenic risk. However, this study ruled out only a fivefold increased risk of major malformations, and not any specific malformations. Of significant concern is a 2011 Zofran side effect study performed by the Slone Epidemiology Center in Boston, Massachusetts and the Centers for Disease Control Prevention in Atlanta. In this Zofran side effect study, there was detected a twofold increased risk of Zofran side effects cleft pallet associated with Zofran taken for morning sickness in pregnancy in the first trimester of the pregnancy. Two separate studies examining a Denmark database for Zofran birth defects found two different

results. While one study found no increased risk of Zofran birth defects while used during pregnancy, this study covered less years than a later study, which covered a longer time period (1997-2010) and more pregnant women (897,018 v. 608,835). In the second study, there was found to be a significantly increased risk for any major malformation, and a twofold risk for a heart defect. In a December 2014 article in Reproductive Toxicology Journal, the available studies were reviewed and analyzed. In this article, which analyzed the potential for Zofran birth defect side effects, it found “a risk increase of cardiovascular malformations and notably septum defects may exist.” The authors suggested that Zofran should not be used off label for morning sickness in early pregnancy “until further large projective studies are available.”

Given these concerning studies, and overall the relative lack of information regarding the safety of Zofran and Ondansetron during the beginning of pregnancy, NGK Law is examining these Zofran side effects for purposes of a Zofran birth defect lawsuit. With the stunning lack of knowledge regarding the safety of Zofran and whether or not Zofran side effects can result in Zofran birth defects during pregnancy, the use of such a medication certainly is cause for concern. Additionally, NGK Law believes it may be grounds for a Zofran birth defects lawsuit. If you used Zofran while pregnant and your child was born with a Zofran birth defect, contact the Zofran birth defect attorneys at NGK Law at 1-844-564-5529 or through our contact form on this page. We look forward to working with you to investigate your potential Zofran birth defect lawsuit.