For additional Zofran information, visit our other Zofran pages: Zofran and birth defects, Zofran studies, Should I Take Zofran While Pregnant?, Zofran Lawsuits or What Types of Birth Defects are Associated with Zofran Use?
Facts About the Louisiana Zofran Lawsuit
In the newest lawsuit against the manufacturer GlaxoSmithKline (GSK), personal injury lawyers for two Louisiana mothers filed a complaint against GSK on June 8, 2015 for the company’s off-label promoting of the pharmaceutical drug Zofran. The complaint alleges that in utero exposure to Zofran caused serious congenital heart defects in the plaintiffs’ newborn babies. The two mothers allege that the Zofran manufacturer unlawfully marketed the drug as a safe and effective anti-nausea drug that could be taken to alleviate or decrease the effects of morning sickness.
The plaintiffs’ prayer for relief ask for damages related to medical expenses, in addition to emotional distress or pain and suffering.
The first plaintiff is alleging that in utero exposure to Zofran during her first trimester of pregnancy led to three major heart defects in her daughter born on July 15, 2010. The defects include ventricular septal defect, atrial septal defect, and intermittent tachypnea, or abnormally rapid breathing.
The second plaintiff, whose daughter was born on August 9, 2005, stated that she was prescribed and ingested Zofran throughout her pregnancy. Her daughter was born with accelerated ventricular arrhythmia, a fault in the electrical systems controlling heart contractions.
Concerns Related to Zofran Use
In this Louisiana Zofran lawsuit, the two mothers filing the complaint say that the drug’s manufacturer hid evidence that the drug increases the risk for various birth defects.
These birth defects include:
- Heart abnormalities, including atrial and ventricular septal defects
- Muscoskeletal defects
- Cleft lip
- Cleft palate
- Kidney defects
- Fetal death
- Fetal growth restriction
Zofran and Pregnancy
The U.S. Food and Drug Administration (FDA) has categorized Zofran, also known as Ondansetron, as a Category B drug. This means that there have not been any well-controlled studies exhibiting the effects that the drug may have on fetal development in utero. Although early studies did not seem to indicate a great risk involved with taking the drug during pregnancy, over half of the women included in those studies – specifically the 2013 Danish study involving more than 600,000 Danish mothers – included mothers who had not been given the drug until after their tenth week of gestation. Since fetal growth and development during the first trimester is most critical, the risks involved with taking the drug during the first trimester are higher.
It is also important to note that a majority of women experience morning sickness primarily during their first trimester. Meaning, a majority of women are prescribed antiemetics or anti-nausea drugs, such as Zofran, during the first trimester to relieve nausea and vomiting.
Later studies, however, concluded that women who took Zofran during the first trimester of their pregnancy were 30% more likely to give birth to a baby experiencing a major birth defect.
Louisiana Zofran Lawsuit: Summary
The complaint filed on June 8, 2015 adds to the growing number of lawsuits being filed against GlaxoSmithKline for their unlawful promoting of Zofran for off-label use.
Zofran was originally approved by the FDA to treat nausea and vomiting in cancer patients undergoing chemotherapy and radiation treatment, as well as given to patients post-operatively. However, the FDA has not approved use of the drug to treat morning sickness in pregnant women, as there is not evidence to support that it is safe and effective for that particular use.
It is important to speak with experienced Zofran attorneys to discuss your legal rights if your child has a birth defect that may have been caused by the pharmaceutical drug Zofran.