June 30, 2015 — A lawsuit (PDF) has been filed in federal court in Louisiana by a woman who claims her use of the anti-nausea drug Zofran during pregnancy caused her son to be born with numerous heart defects.
The lawsuit was filed by Alexis Alexander on behalf of her child, “N.A.,” who was born in 2006 with atrial septal defect (“hole in the heart”) and partial anomalous pulmonary venous return.
Alexander took Zofran beginning early in her first trimester and continued taking it through her third trimester to alleviate symptoms of morning sickness. Her son has already had two surgeries to treat his heart defects.
According to the complaint:
“There is no known genetic cause for N.A.’s condition. N.A. has no family history of any of the conditions from which he suffers. In addition, N.A. has two siblings who were born healthy and vibrant after Ms. Alexander carried them for full-term pregnancies.”
Alexander is not the first mother to come forward and seek justice for her child’s birth defects. GlaxoSmithKline (GSK), the manufacturer of Zofran, is now facing about a dozen similar lawsuits. All of the lawsuits accuse GSK of negligence for failing marketing Zofran to pregnant women without studying its risks or warning women about the potential danger to a developing baby.
Heart defects occur while the heart is developing during the first trimester. This is also when when morning sickness is at its worst. Unfortunately, a recent study published in Reproductive Toxicology found that babies exposed to Zofran in the womb were twice as likely to develop a “hole in the heart” defect. These defects often require surgical repair very early in life.