Zofran, which could be more commonly known by its generic name ondansetron, may potentially cause birth defects in babies when their mothers are on the prescription drug during pregnancy. GlaxoSmithKline, the pharmaceutical company from London, England that manufactures Zofran, insists that their drug does not pose an immediate threat to unborn children. Those who have taken Zofran while pregnant are telling a different story.
A couple from Illinois filed a lawsuit indicating that while the woman was pregnant with their child, she was prescribed Zofran by her doctor as a way to treat nausea and morning sickness symptoms. She claims that the makers of Zofran did not provide any label or indication that would suggest birth defects could be a possible side effect of taking this medication. She believes that if GlaxoSmithKline provided a warning label or any general knowledge that this could transpire, then her son may not have been born with a heart defect that will impact his entire life. Her son had been born with Tetralogy of Fallot, a congenital heart defect that causes oxygen in the blood to reach poor levels—a complication that requires immediate heart surgery at the time of detection and further surgeries in the future. This young boy, who is about nine years old now, suffers from a condition that deeply affects all aspects of his life. The defect puts him at a greater risk for infection, and there’s a possibility that the tissue lining of his ventricular septal could detach and block his arteries. If this were to happen at any point in the future, he would need to be rushed to the hospital within an hour or he could die from this occurrence. All of these issues stemming from the mere fact that his mother received a prescription for medication she should have never been allowed to take in the first place.
Zofran should only be used in extreme cases of nausea and vomiting that are caused by surgical procedures or cancer treatment. The FDA never approved Zofran to be used to treat these symptoms in any other case. It was to be used primarily for cancer patients who were having a difficult time adjusting to their chemotherapy and other treatments. Once provided with that information, it becomes hard to understand why women would not be warned of potential issues that could arise from taking this drug simply to help treat their morning sickness.
If you were to conduct a basic Google search of Zofran in order to learn more about this particular drug, you could find evidence that supports the idea that those manufacturers never explicitly claimed that Zofran was unsafe for the use in pregnant women. You would, however, find statements like this, “Zofran is not for preventing nausea or vomiting that is caused by factors other than cancer treatment or surgery.” Although this doesn’t specify whether or not Zofran is suitable for use in women that are pregnant, that concise statement is hard to argue with.
Those who have suffered birth defects to their children in relation to their intake of Zofran still maintain a strong case in their favor. GlaxoSmithKline reached a settlement with the United States Department of Justice in 2012 for $3 billion for illegally marketing their product. Lawyers representing clients who fell victim to the side effects of Zofran said that this development is helping to strengthen their case against the pharmaceutical giant. The family whose son was born with Tetralogy of Fallot is just one of countless families pursuing a lawsuit to gain justice. Due to the growing number of these complaints, GlaxoSmithKline has asked that in the future they would like to be able to have all of these cases centralized before a single judge so they can be addressed accordingly.
The birth defects arising as a result of Zofran use in pregnant women cover a wide range. They could include heart defects and heart failure to cleft palate defects—this occurs when a child’s lip or roof of their mouth becomes split during pregnancy. Zofran had purportedly received a rating of “Pregnancy Category B” which would indicate that animal testing of this drug did not produce any concrete evidence that it would later become harmful in subjects who are pregnant. Those who are fighting against GlaxoSmithKline say that at the very least, Zofran should receive a rating of “Pregnancy Category D” which would indicate to consumers that this drug could potentially cause fetal risk to pregnant women. The ongoing influx of information about birth defect potential suggests that perhaps the rating could even go so far as being classified as “Pregnancy Category X” which would explicitly state that Zofran should not be used by women who are pregnant or may become pregnant.
Mislabeling drugs and misleading consumers about potential side effects is a course of action that should not be tolerated. Patients should always be fully aware of each and every single possible side effect that they may encounter when they are prescribed a certain drug to treat a certain ailment. The influx in complaints against Zofran consumption and GlaxoSmithKline will hopefully lead to families receiving justice for what has happened to them, and prevent further families from suffering in the future.
Additional information regarding cases and Zofran may be found at the following links: http://www.youhavealawyer.com/blog/2015/07/23/zofran-warnings-pregnancy-category/