Zofran Birth Defects Claims Gaining Momentum

Pittsburgh, PAIn the wake of a few Zofran birth defect lawsuits filed against GlaxoSmithKline last month, women who took Zofran during their pregnancy for nausea are increasingly becoming aware that Zofran was not safe and that the drug company chose profit over safety.

GlaxoSmithKline (GSK) has been accused in the lawsuits of failure to warn - and more. According to the plaintiffs, the drug company marketed Zofran to pregnant women while concealing the knowledge to both health care workers and consumers that it has a risk of birth defects. In fact, the FDA never approved Zofran specifically for the treatment of morning sickness in pregnant women, which means that it was being prescribed off-label. (Doctors can legally prescribe off-label but manufacturers cannot market their drugs for off-label use.)

Court documents indicate damning information recently surfaced about GSK and Zofran in the lawsuits. The plaintiff in case 1:15-cv-10429, filed February 16 in the U.S. District Court, District of Massachusetts, claims that GSK was aware of laboratory studies that allegedly linked intrauterine deaths and malformations in animals that were administered Zofran. And GSK knew that animal studies conducted on Zofran indicate that the drug cannot be used safely or effectively in pregnant women. The plaintiff claims that her daughter was born with birth defects after using Zofran to treat nausea during her pregnancy.

Another lawsuit filed on February 12 in the U.S. District Court in Pennsylvania (2:15-cv-00709PD) claims that GSK marketed the drug off-label (i.e., without FDA approval) to treat morning sickness in pregnant women and at the same time, the company had no evidence to support Zofran’s safety for unborn children. According to court documents, the lawsuit accuses GSK of knowing that Zofran readily crosses human placental barriers during pregnancy. The plaintiff in this case claims that she used Zofran during two of her pregnancies and both children were born with heart defects.

GSK admits that the drug was never tested on pregnant women, which is a dilemma in itself. Because pregnant women are almost always excluded from drug trials, they can be denied medication or worse (as in the case of Zofran): they can be given untested medication that can harm the unborn child. For a mother to be included in a drug trial, the benefit of the drug must far outweigh the risk.

Both lawsuits further claim that GSK since 1992 has received literally hundreds of Zofran birth defects reports associated with prenatal exposure to the drug. That might just be the tip of the iceberg.

A study published in the American Journal of Obstetrics and Gynecology reported that about 110,000 pregnant women received monthly prescriptions for Ondanestron (Zofran is the brand name) by the end of 2013. Of course these expectant mothers were unaware of Zofran birth defects, even though the FDA had issued warnings about birth defects.

In the Canadian Family Physician Q&A in 2012, a physician asked if ondansetron was safe to use during pregnancy and that some of his patients with severe nausea and vomiting of pregnancy (NVP) received ondansetron in hospital. The answer was NO, and partially blamed the FDA for lack of another approved drug to treat NVP. Zofran was designed and approved for chemotherapy-induced nausea and vomiting, and for use in nausea and vomiting associated with radiation therapy, anesthesia and surgery.

In September 2011, the FDA issued a warning about possible serious QT prolongation (a heart rhythm disorder that can potentially cause rapid and sporadic heartbeats) and torsade de pointes (the potential of ventricular tachyarrhythm or ventricular fibrillation, which will lead to sudden death) among women using Zofran.

And going back to 2004, the Motherisk program at the Hospital for Sick Children in Toronto, Ontario, questioned the fetal safety of ondansetron.

Zofran has been increasingly used off-label for more than a decade. How could GSK not know?