Once again, the multinational pharmaceutical GlaxoSmithKline (GKS) is making headlines for endangering patients by marketing its drugs for unapproved purposes. The use of its drug Zofran (generic form: Ondansetran) has been linked to an increased risk of birth defects when prescribed to women to alleviate morning sickness during the first trimester of pregnancy. Zofran is a powerful anti-nausea medication normally prescribed to chemotherapy and radiation patients. In recent years, doctors have been prescribing it to pregnant women suffering from morning sickness, although this use is considered off-label, meaning it is not FDA approved. This has led to an increased risk of birth defects like:
- heart problems
- cleft lip
- cleft palate
- kidney problems
- intrauterine growth restrictions (IUGR)
- Musculoskeletal abnormalities
The use of Zofran to treat nausea in pregnant women has not been approved by the FDA because adequate studies have not been conducted to test its safety. The drug therefore has been given an FDA rating of Pregnancy Category B. And while a 2013 study published in the New England Journal of Medicine concluded that the use of Zofran did not increase the risk of birth defects, the drug's use during the first trimester of pregnancy was not adequately tested. Half of the women in this study took Zofran only after the 10th week. At this stage, babies no longer face a risk of developing birth defects such as heart problems, cleft lip, or cleft palate.
In fact, a study by The Center for Birth Defects Research and Prevention, published in 2012, suggested that the use of Zofran during the first trimester led to a two-fold increase in the risk of birth defects. Similarly, a 2014 study titled Use of Ondanesetron [Zofran] During Pregnancy and Congenital Malformations in the Infant, concluded that the use of Zofran during the first trimester more than doubled the risk of birth defects such as cleft palate and that cardiovascular defects like cardiac septum were increased and statistically significant.
So why have doctors been prescribing this drug to pregnant women when its safe use has not been established? The answer is probably an aggressive marketing campaign by its manufacturer. GSK has a history of dangerous off-label marketing of its medications. The pharmaceutical company was forced to pay a record $3 billion dollars in 2012 for marketing medications for uses not approved by the FDA—the largest medical fraud penalty ever imposed in the U.S. In addition, GSK was forced to pay fines for providing illegal kickbacks to doctors that prescribed GSK drugs for unapproved uses.
As the links between unfortunate birth defects and the use of Zofran during pregnancy become clear, the time to act is now. It's important to hold profit-driven pharmaceuticals accountable for continuing to endanger the public with their risky off label marketing. If you believe that your child may have been injured because of the use of Zofran during your pregnancy, it's critical that you seek out competent legal help. Hilliard Muñoz Gonzales, LLP has the resources, knowledge and professional expertise to protect your interests in dealing with the effects of Zofran use. If you were prescribed Zofran during your pregnancy give us a call or send us an <email> with any concerns you may have about how Zofran has impacted you and your loved ones.