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Zofran Birth Defects

Making its way onto the U.S. Market in 1991, ondansetron, commonly known as Zofran, is a medication meant to alleviate the vomiting and nausea often experienced by surgical patients and those undergoing chemotherapy treatments. This 5-HT3 antagonist operates on the nervous system to facilitate the gastric emptying process and block serotonin. In addition to these FDA-approved applications, Zofran is routinely prescribed to pregnant women in the grips of debilitating morning sickness, often referred to as hyperemesis gravidarum. Though extremely common, this so-called “off-label” use of the drug has begun to raise concerns among members of the medical community and expectant mothers.

Allegations of a connection between the use of Zofran and birth defects in infants have emerged and an increase in litigation is anticipated.

Frequency of off-label Zofran use

Morning sickness is something likely to impact an estimated 80% of all pregnant women, and the accompanying vomiting and proves truly debilitating for some. The condition known as hyperemesis gravidarum is a particularly severe form of morning sickness and may bring about muscle wasting, nutritional deficiencies, harmful dehydration and the loss of 5% or more of the expectant mother’s body weight. The dangers this affliction can pose to mothers and infants are obvious. Thus, the availability of a drug such as Zofran which has been found to ameliorate such negative manifestations has long been welcomed by physicians and pregnant women alike. The ability to resume daily functions and eliminate the risks dehydration and nutritional loss pose to the unborn child has been viewed by many as a virtual godsend.

It must be noted, however, that this particular use of Zofran has never been granted approval by the FDA, and insufficient research has been conducted as to its safety. The medication currently bears “Category B” classification, signifying the fact that while animal studies of the drug have not revealed a specific risk to fetuses, no major studies done under controlled conditions have been undertaken to establish its safety for use in pregnant women. Though the FDA has not issued specific warnings about Zofran with regard to pregnant women, it has alerted the public to potential complications affecting adult patients with existing heart conditions. These facts are seen by many as additional support for the growing allegations of the dangers posed by Zofran to unborn children.

Studies regarding Zofran and birth defects

Recent research has sparked additional concern about the use of Zofran as a morning sickness treatment and its potential for causing serious birth defects in babies. The New England Journal of Medicine published a study in 2013 which did not find a link between the drug and increased incidence of birth defects. Researchers assessed data points taken from the Danish Medical Birth registry and charted outcomes of pregnant women who received Zofran and gave birth during the 2004-2011 time frame. Critics of the study pointed to the fact that the average gestational age of the subject fetuses when exposed to Zofran was 10 weeks, a stage by which the greatest risk of serious birth defects has already passed.

Subsequently, another study was conducted by a new group of researchers. The same Danish birth registry was used to cull data for the survey, though the time period examined was expanded significantly. The study’s ultimate conclusions were based on a review of 900,000 birth events occurring between 1997 and 2010. The researchers behind this study found that the use of Zofran correlated to double the risk of infant heart defects and a 30% jump in the risk of birth defects as a whole. 4.7% of the subject women who had taken Zofran during early pregnancy had babies with congenital defects, as compared to 3.5% of women who had not used the drug.

Zofran and heart defects

Perhaps the most serious birth defect allegedly caused by the use of Zofran in early pregnancy is that of the atrial septal defect. This condition is characterized by the presence of a hole in the wall separating the two upper chambers of the heart. Atrial septal defect is present in those affected from the time of their birth and can pose serious dangers, particularly if it goes undetected. While minor defects of this type may close on their own without intervention in early childhood, long-standing defects can cause real harm to the lungs and heart.

Surgical repairs are often needed to ameliorate the risk of complications in young patients. Adults with undetected atrial septal defects may experience early death due to heart failure or hypertension as well as symptoms such as frequent lung infections, swelling of the extremities, fatigue and shortness of breath. Clearly, Zofran heart defects are cause for real concern among mothers who have or are considering using this drug to address their morning sickness symptoms during pregnancy.

Legal options for affected families

Considering the severity of the dangers posed by the suspected risk of Zofran use in early pregnancy, it should come as no surprise that growing numbers of women with children affected by these birth defects are exploring their legal options. As prospective plaintiffs and their attorneys begin delving into the history of Zofran and its frequent off-label usage by pregnancy women, troubling facts continue to emerge.

It has been alleged that GlaxoSmithKline, the maker of Zofran, had early knowledge of the drug’s dangers to unborn children, yet continued to actively market its use by expectant mothers. The drug giant has already reached a settlement agreement with the U.S. Department of Justice regarding illegal marketing of off-label uses of many of its products as well as its failure to disclose safety data, a fact certain to be underscored in ensuing litigation.

Claimants interested in pursuing a Zofran lawsuit are likely to make numerous legal arguments that may include:

  • Negligence
  • Breach of express and implied warranties
  • Fraudulent concealment
  • Strict products liability
  • Deceptive trade practices
  • Negligent misrepresentation of safety data and research

Successful litigation may recover financial compensation for things such as:

  • Past, present and future medical expenses
  • Physical pain and suffering
  • Emotional distress
  • Rehabilitation and therapy costs

As more and more women become aware of the potential link between their use of Zofran as a morning sickness treatment and their children’s severe and often life-altering birth defects, the volume of lawsuits is almost certain to grow. GlaxoSmithKline’s response to these allegations and resulting litigation strategy both remain to be seen.

  1. The Toronto Star, Birth defects blamed on unapproved morning sickness treatment,

  2. U.S. Department of Justice, GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data,

  3. Centers for Disease Control and Prevention, Facts about Cleft Lip and Palate,

  4. Mayo Clinic, Diseases and Conditions -  Atrial septal defect,