Why was Zofran prescribed for use by pregnant women without being approved by the FDA?

When a pregnant women is suffering from debilitating nausea and vomiting, also known as hyperemesis gravidarum, her doctor may feel compelled to find a medication that can help ease the unpleasant symptoms. The patient may be struggling to carry out daily activities as a result of the nausea, including the ability to work or care for older children. For this reason, many physicians have chosen to prescribe the anti-nausea drug Zofran to treat morning sickness. The medication was not specifically approved by the U.S. Food and Drug Administration (FDA) for this use.

Why Zofran Was Prescribed for Off-Label Use

When a physician prescribes a medication to treat a condition in a manner that is not specified in the FDA’s approved packaging label, this means that the drug is being used off-label. The off-label use of Zofran to treat morning sickness has since been linked to birth defects. Why would doctors have prescribed the drug for this use if doing so was potentially dangerous? The following is an overview:

  • The process of prescribing drugs for off-label use is legal and common.
  • GlaxoSmithKline advertised the use of Zofran as a safe treatment for morning sickness. Unfortunately, we now know that not only was the drug not approved specifically for this use, but it also has been linked to dangerous birth defects. In addition, the company did not properly evaluate all of the data to ensure that the drug was safe for this use.
  • The FDA regulates drug approval, not drug prescribing. In other words, the FDA regulates whether a drug is approved, and for what uses and doses. It does not, however, oversee how doctors actually choose to prescribe the drug. Physicians are free to prescribe a drug for any reason they believe to be medically appropriate.

Unfortunately, many patients who take drugs for off-label uses are not told that the drug is being used in this way. This can create a false sense of security that the drug is safe for use. Pregnant women therefore may have chosen to take Zofran at the recommendation of their prescribing physician under the false assumption that the medication was approved for use during pregnancy. We now know that use of the drug during pregnancy can lead to birth defects.

If you used Zofran during pregnancy and suffered harm as a result, we are here to help. Check out our many client testimonials to learn more about our work representing victims of dangerous drugs.

David Hodges
Connect with me
David Hodges is a founding partner of Kennedy Hodges. He focuses his practice on personal injury claims.