Off-Label Use of Zofran Can Cause Birth Defects?

In February 2015, two lawsuits were filed in federal courts alleging that the use of Zofran during pregnancy increased birth defects. These lawsuits are aimed at GlaxoSmithKline LLC, the maker of Zofran, and seek compensatory and punitive damages, equitable relief, and other relief deemed just and proper arising from the injuries as a result of prenatal exposure to Zofran.

What is Zofran? What Does It Treat?
Zofran (also known as Ondansetron) is used to prevent nausea and vomiting. Although traditionally used to treat nausea associated with cancer chemotherapy, surgery, and radiation therapy, it has also been used off-label to treat morning sickness during pregnancy, even though the Food and Drug Administration (FDA) never approved the use of Zofran for morning sickness during pregnancy.

In the current lawsuits, plaintiffs allege that GlaxoSmithKline actively marketed Zofran, off-label, as a safe and effective treatment for a common side effect of normal pregnancy (pregnancy-related nausea and vomiting, or morning sickness). Allegations against GlaxoSmithKline include promoting the drug while failing to undertake a single study on the effects of Zofran on pregnant mothers or their unborn children, arguably because conducting these studies would have delayed the marketing of Zofran and associated profits. In this sense, pregnant mothers and their unborn children were arguably the test subjects for the drug.

Plaintiffs also allege that GlaxoSmithKline was actually aware that Zofran was unsafe for ingestion by pregnant women based on animal studies done in the 1980s, which revealed evidence of toxicity, intrauterine deaths, and malformations in offspring. Plaintiffs also assert that this evidence was supported by reports of birth defects submitted to GlaxoSmithKline in the 1990s and 2000s.

What Does the Science Say?
The Center for Disease Control (CDC) knew of these potential birth defects, as a 2011 study completed with grant money from the CDC reported on the risks, but the drug continued to be promoted to pregnant women. More recently, Dr. Gideon Koren’s study published in the American Journal of Obstetrics and Gynecology points out that about 1 million pregnant women are exposed to Zofran or its generic every year. This use off-label is at the heart of the current controversies and court battles: there is solid, public evidence that Zofran may be the cause of such birth defects as congenital heart defects, cleft palates, and cleft lip. Other potential birth defects include kidney malformations, mouth deformities, musculoskeletal malformations, fetal growth restriction, and fetal death. Side effects for mothers can include swelling, constipation, irregular heartbeat, dizziness, fainting, rashes, hives, and itching.

In 2012, GlaxoSmithKline pled guilty to criminal charges lodged by the United States Department of Justice for its off-label promotion of Zofran for uses never approved by the FDA. GlaxoSmithKline also entered civil settlements and had to pay a $3 billion settlement for the company’s unlawful promotion of several prescription drugs, including Zofran, as well as paying doctors to prescribe the drug. The settlement will compensate plaintiffs who allege that they were encouraged to use these drugs, but it does not compensate them for alleged injuries resulting.

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