June 30, 2015 — The mother of a baby who was born with a “hole in the heart” defect has filed a lawsuit (PDF) against GlaxoSmithKline (GSK) accusing the drug-maker of failing to warn about the birth defect risks associated with Zofran.
Zofran, an anti-nausea drug, is commonly used by pregnant women for the “off-label” (unapproved) treatment of morning sickness. The problem is that Zofran has never been evaluated for safety during pregnancy, and a growing number of studies have found evidence of birth defects.
The lawsuit was filed on June 26 in the U.S. District Court for the Eastern District of Louisiana. The plaintiff, Alexis Alexander, filed the complaint on behalf of her son, “N.A,” who was born in 2006 with numerous heart defects.
The boy’s heart defects include atrial septal defect (“hole in the heart”) and partial anomalous pulmonary venous return. Last year, a study published in Reproductive Toxicology found that Zofran doubled the risk of “hole in the heart” defects.
Although N.A. is only nine years old, he has already undergone 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.”
The Justice Department has accused GSK of improperly marketing Zofran for pregnant women with morning sickness. The drug-maker is now facing a rapidly-growing number of lawsuits accusing them of negligence.