Zofran 101: An Introduction to the Controversial Drug

Published on April 10, 2015 by

What is Zofran?

The multi-billion dollar pharmaceutical giant, GlaxoSmithKline (GSK), developed Zofran nearly 25 years ago to help cancer and surgery patients manage extreme nausea and vomiting.

In 2006, the U.S. Food & Drug Administration (FDA) approved generic versions of Zofran (also technically known as “ondansetron”). Shortly thereafter, for reasons that are debated, doctors began prescribing the drug en masse for “off label” uses. (“Off-label” refers to the use of a medication for something other than what the drug was officially approved to treat.)

The most prominent of these “off label” uses involved treating pregnant women with an extreme kind of morning sickness known as “Hyperemesis Gravidarum.” This condition typically presents early in the pregnancy, and it only happens in about one out of every one hundred pregnancies. Hyperemesis Gravidarum can cause serious risks both to the fetus and to the mother, including dehydration, electrolyte imbalances, acid reflux, loss of nutrition, and muscle problems. Many women need to be hospitalized.

Doctors thought that Ondansetron could be useful to treat morning sickness for several reasons:

  1. At the time, physicians didn’t have other “go-to” drugs to help pregnant women with this problem.
  2. Zofran is technically known as an “5-HT3 antagonist.” That means it suppresses the release of an important neurotransmitter called serotonin, and, at the same time, forces the stomach to empty faster, thereby reducing the likelihood of painful vomiting.
  3. GlaxoSmithKline educated doctors to view the drug as a highly effective and appropriate antiemetic [drug that makes you stop being nauseous].

What Went Wrong?

In theory, this use of the drug made sense. However, as Thomas Huxley once eloquently warned: “The great tragedy of science [is] the slaying of a beautiful hypothesis by an ugly fact.”

There have been plenty of “ugly facts” that have emerged over time to challenge this particular pharmaceutical avenue for treating morning sickness. For instance:

  1. The Federal Drug Administration (FDA) never approved Ondansetron to be used by pregnant women.
  2. The safety data for this drug was pooled from a set of just 200 fetal records.

Think about that for a second.

Millions of American pregnant women and their fetuses have been subjected to this drug, yet the safety data comes from just 200 fetuses. That is, by any measure, a staggeringly thin body of evidence.

Legal Recourse

To explore the possibility of bringing legal action right away to obtain compensation for Zofran -related birth defects, please call the experienced attorneys at Marc Whitehead & Associates, LLP at (855)-423-3666. For more information regarding Zofran please download a copy of our free E-book, The Zofran Tragedy.