What Are the Side Effects of Zofran Being Prescribed for “Off-Label” Uses?

Published on April 17, 2015 by

The FDA classifies Zofran (also technically known as “Ondansetron”) as what’s known as a “Pregnancy Category B” drug. That means that, while animal trials have not found any “red flags,” it is impossible to say, based on current data, whether the drug is safe for widespread use among humans.

Nevertheless, by 2013, over one million pregnant women annually were being prescribed this drug to treat their morning sickness in this so-called “off-label” fashion.

You might wonder why doctors were so keen to prescribe a drug that hadn’t been beta tested appropriately. GlaxoSmithKline’s intense marketing efforts probably helped. But doctors who profusely wrote scripts for Zofran also noted that severe morning sickness is inherently painful and dangerous, so “doing something” seemed preferable to “doing nothing.”

In 2013, the FDA approved a different medication, Diclegis, providing doctors with a new anti-nausea drug for their arsenals. So far, Diclegis treatment seems to be up to the task, and doctors are increasingly turning to it as an alternative. However, science suggests that the widespread deployment of Zofran may have already caused serious unintended consequences.

The Alleged Problems with Zofran

There are two basic issues that have been alleged:

  1. Zofran may cause many different types of birth defects. These include cleft palate, kidney defects, craniosynostosis, musculoskeletal problems, mouth and facial deformities, jaundice and heart defects (e.g. ventricular septal and atrial septal defects). Other possible defects include: neural tube defects, limb deformities (club foot, etc.), spina bifida and potentially other brain deformities.
  2. Ondansetron may directly harm pregnant women who take the drug by causing problems like Serotonin Syndrome and cardiac problems.

In our next posts, we’ll take a closer look at the evidence linking the drug with these problems.

To explore the possibility of bringing legal action right away to obtain compensation for Zofran-related birth defects, please call the experienced attorneys here 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.