For additional Zofran information, visit our other Zofran pages: Zofran and birth defects, Zofran studies, Should I Take Zofran While Pregnant?, or What Types of Birth Defects are Associated with Zofran Use?
It would be hard to miss the television commercials talking about Zofran lawsuits. This page is intended to provide information about why the lawsuits exist and what to do if you believe that you may have a lawsuit again GSK, the makers of Zofran.
Zofran Lawsuits Stem from Widespread Zofran Use
When a mother is pregnant with her child, it is a truly unique and beautiful experience. From feeling your child’s first kick, to watching them grow and develop over the course of your pregnancy, a mother’s primary concern is for her child or children. Most mothers would do anything that they can to protect their children, so it is disheartening when you learn that something you did during your pregnancy, such as taking a medication that was prescribed to you by a medical professional, may have unintended side effects for your baby.
Zofran is one of the most widely prescribed anti-nausea medications used during pregnancy. It is clear that Zofran, or its generic brand Ondansetron, has been prescribed to at least hundreds, if not thousands, of expectant mothers across the nation. Unfortunately, there may be some side effects that these mothers may not have been warned about.
Zofran Lawsuits Claim Off-Label Use
Many expectant mothers are wary about taking any medications during their first trimester, as their baby’s development is crucial during these first three months. Morning sickness is a common ailment in many mothers, especially during their first trimester. The prescription drug Zofran, manufactured by the drug company GlaxoSmithKline, has been advertised “off-label” for use by pregnant women. Used primarily for nausea and vomiting, recent studies have indicated that Zofran-use may come with serious side effects to both the mother and her unborn child.
What is Zofran (or Ondansetron)?
Zofran is a prescription medication that has historically been used to treat nausea and vomiting in patients undergoing chemotherapy or radiation, as well as for postoperative nausea and vomiting. It has been used off-label for use in pregnant women experiencing morning sickness. This drug works by blocking the body’s natural chemicals and substances, such as serotonin, that cause both nausea and vomiting. It can be administered intravenously, through injections, or orally via a rapidly disintegrating tablet.
It is estimated that more than 50% of pregnant women experience some form of morning sickness during their first trimester. In instances where at-home remedies are unsuccessful, it is likely that a medical professional may prescribe Zofran in order to alleviate the symptoms of morning sickness.
What are the risks associated with Zofran?
According to recent studies, Zofran has been linked to a 30% increased risk of birth defects, and a doubled risk of various heart defects and cleft palate in children. If you would like more detailed information, please see BIG’s article detailing the studies linking Zofran to birth defects. Some of the other potential risks associated with Zofran use during pregnancy include:
• Abnormal heart rhythm, also known as arrhythmia
• Other heart defects, including septal defects, tachycardia, or holes in the heart
• Muscoskeletal deformities
• Cleft lip or cleft palate
• Skeletal abnormalities, defects, or disfigurement
• Kidney malformations
In late 2011, the Food and Drug Administration (FDA) issued a safety announcement informing the public of an ongoing safety review of the anti-nausea medication known as Zofran. This also includes the generic brands ondansetron, ondansetron hydrochloride, and their generics. According to the FDA, these drugs may actually increase the risk of developing abnormalities in the electrical function or activity of the heart, which may result in a potentially fatal abnormal heart rhythm.
In 2012, the Justice Department sued the drug manufacturer GlaxoSmithKline $3 billion for improperly marketing Zofran and other drugs. While it was originally approved for use by patients experiencing nausea and vomiting caused by chemotherapy, radiation, or surgical procedures, Zofran is a Category B drug and has not been shown to be safe for use in pregnant women.
What is a Category B Drug?
According to the FDA pregnancy categories, a drug classified as Category B means that animal reproduction studies have not shown a potential risk to the fetus, but there are no adequate and well-controlled studies in pregnant women. The anatomy of animals is not necessarily the same as that in humans, and the animal reproduction studies may not be representative of the potential effects that the drug may have in humans. Recent studies in Sweden and Canada have shown an increased likelihood of birth defects associated with Zofran use.