Morning sickness is something that most women contend with during pregnancy. Although it is normal and rarely dangerous to the mother or baby, it can be debilitating and it is a source of great suffering. Zofran (ondansetron) is an anti-nausea medication that became popular as a treatment for morning sickness. And it worked. But Zofran has been linked to an increased risk of serious birth defects, and it was never even approved for use in pregnant women.
Zofran was approved by the U.S. Food and Drug Administration (FDA) in 1991, to treat nausea and vomiting but only in two specific groups of people. Zofran is approved to prevent and treat nausea and vomiting in cancer patients undergoing chemotherapy or radiation, and to prevent and treat post-surgical nausea and vomiting.
Zofran is not and never has been approved for use in pregnant women.
Illegal and Unethical Marketing
Although doctors are allowed to prescribe medicines for unapproved uses when they believe it is in the patient’s best interests, drug companies are not allowed to market their products for any purpose other than what they were specifically approved for. When they do it is referred to as off-label marketing, and it is illegal.
In 2012, Zofran maker GlaxoSmithKline LLC (GSK) agreed to a settlement with the government without admitting guilt. In part, the settlement related to off-label marketing of Zofran to treat morning sickness in pregnant women.
The fact that Zofran wound up in the hands of pregnant women and caused birth defects was not some innocent and unintended consequence of the drug hitting the market. GSK was notified of birth defects resulting from Zofran use in early pregnancy as early as 1990, and yet it proceeded to begin aggressively push the drug as a safe treatment for morning sickness in 1991.
Several studies have found an increased risk of birth defects in babies born to women who took Zofran:
- 2012 – The Slone Epidemiology Center and the Centers for Disease Control and Prevention (CDC) reported a two-fold increase in the risk of cleft palate associated with Zofran use in the first trimester of pregnancy.
- 2013 – A study was published that looked at data on nearly 900,000 pregnancies, found that Zofran use was associated with a 30% overall increased risk of birth defects and a doubled risk of heart defects.
- 2014 – A study by Swedish researchers, published in Reproductive Toxicology, found that Zofran use in early pregnancy doubled the risk of septal heart defects.
Zofran use in pregnancy has been associated with:
- Congenital heart malformations
- Heart murmurs
- Orofacial clefts
- Skeletal abnormalities
- Kidney malformation
- Fetal growth restriction
- Fetal death
- Life-threatening pregnancy complications
- Serotonin syndrome in the mother