California Zofran Lawyers
Please Note: Our law firm is no longer taking Zofran cases. The following article is for information only.
Zofran is an anti-nausea drug intended to help cancer patients undergoing treatment. However, it is a drug that is often used "off-label" to treat pregnant women experiencing morning sickness. This drug has been linked to numerous reports of birth defects. In fact, studies have shown a 30 percent increased risk of birth defects, particularly heart defects and cleft palates, among children of women who took Zofran during pregnancy.
How Does Zofran Work?
Zofran (generic name: ondansetron) is an anti-nausea drug, which was approved by the U.S. Food and Drug Administration (FDA) for cancer patients undergoing chemotherapy and surgery. The drug is manufactured by GlaxoSmithKline and has been in the market since 1991. It is important to note that the FDA did not approve the use of Zofran to treat symptoms of morning sickness in pregnant women.
This is known as an "off-label" use for the drug. The FDA categorizes Zofran as a "Category B" drug during pregnancy. This means that there are no test data to prove that this drug is safe for pregnant women to use. Zofran has also been linked to deadly or devastating side effects for the children of pregnant women to took them to treat nausea.
According to several recent research studies, it has been proven that Zofran is passed from the mother to the fetus through the placenta. Also, studies show that the effects of the drug remain active in the baby much longer than they are in the mother. Studies conducted over the last five years by researchers in Denmark and Australia have found that women who take Zofran during pregnancy or two or three times more likely to give birth to children with birth defects.
Common Zofran Birth Defects
Here are some of the most common birth defects reported in children whose mothers took Zofran during pregnancy:
- Atrial septal defect: This is a congenital heart disorder where there is a defect in the wall (septum) that connects the two upper chambers of the heart. In babies with the defect, this wall is incomplete allowing blood to flow back and forth between the two chambers putting undue strain on the heart.
- Aortic arch hypoplasia: The aorta is the largest artery in the human body that brings oxygen-rich blood from the heart to other parts of the body. The aortic arch is the part, which connects the aorta to the heart. When this arch does not form fully, it can become blocked. Blood flow could become diminished or interrupted. Children with this birth defect need open-heart surgery. Some children even need multiple surgeries for the defect to be corrected.
- Cleft palate: A cleft palate is a split or opening in the roof of the mouth. Researchers have found that women prescribed Zofran were nearly three times more likely to deliver a child with cleft palate.
- Loss of hearing: This is often linked to orofacial defects such as cleft palate because the mouth is closely connected to the sinuses. An opening can cause frequent ear infections and result in permanent damage to the parts of the ear that make hearing possible.
- Webbed toes: This could occur if the child's early development is affected. Webbed toes occur when two or more toes remain fused.
The Department of Justice sued GlaxoSmithKline, the manufacturer of Zofran, for illegal promotion and failure to report safety data for many of its drugs including Zofran. The pharmaceutical giant not only pleaded guilty to illegally promoting Zofran to treat morning sickness in pregnant women, but also agreed to pay $3 billion in 2012 to resolve those charges. The company is also facing civil lawsuits from families of children who have suffered birth defects as a result of the drug.