Congenital Heart Defects

Since 1991, many women suffering from nausea and vomiting during pregnancy have turned to Zofran (Ondansetron), a drug originally approved to treat these same symptoms in cancer and post-surgery patients but often prescribed to pregnant women “off-label.” Unfortunately, recent studies have linked Zofran as the cause of several congenital heart defects such as the following:

  • Atrial Septal Defects – Holes in the wall between the two upper chambers of the heart
  • Ventricular Septal Defects – Holes in the walls separating the heart’s lower chambers
  • Atrioventricular Septal Defects – Holes between the chambers and valves of the heart

Symptoms related to these defects include difficulty breathing, irregular or rapid heartbeats, easy tiring, heat palpitations, lung infections, heart murmurs, and cardiac arrest.

In 2013, one study found that women who are prescribed Zofran during pregnancy have about a 20 percent increased risk of having a child with a serious heart defect. Specifically, children’s risk of developing atrial septal defects is increase by 2.1 times, ventricular septal defects by 2.3 times, and atrioventricular defects by 4.8 times. Another study conducted in 2014 found similar results and concluded that when women are given Zofran early in their pregnancy, they are 1.62 times more likely to give birth to a child with an underdeveloped heart. View more information regarding the dangers associated with Zofran.

Although complications due to Ondansetron most commonly develop in children prior to birth, young children are also at risk at developing heart complications after birth. In early 2015, two cases, one involving a 10-year-old and one involving an 86-day-old infant, resulted in the death of both children after being given Ondansetron and having heart complications.