Zofran is not approved for pregnant women, but doctors frequently prescribe it “off-label” to treat extreme morning sickness.
In 2012, the manufacturer of Zofran reached a $3 billion settlement with the Justice Department, which accused the drug-maker of illegally marketing Zofran for morning sickness and paying kickbacks to doctors who prescribed the drug.
Investigators with the Toronto Star looked at a public database of side effect reports involving Zofran and found 20 cases involving birth defects, premature birth, or fetal death. All of the reports were submitted to the FDA by Canadian women between 2010 and 2013.
Some of the most devastating outcomes included:
- Two fetal deaths
- Fetal growth restriction (IUGR) in six infants, including four babies who weighed as little a 4.5 pounds. This condition involves very poor growth in the womb, in the bottom 10th percentile for gestational age.
- One baby was born with a “musculoskeletal abnormality”
- Multiple reports of heart defects and kidney malformations
- One doctor suspected Zofran was the cause of a baby’s mouth deformity, jaundice, heart murmur, and two heart defects, including atrial septal defect (“hole in the heart”)
The findings add to a growing body of evidence linking Zofran and birth defects. A recent analysis of a Danish registry of pregnancy outcomes found that Zofran doubled the risk of having a baby with a heart defect, and increased the risk of birth defects by 30% overall.
Another study, published in 2011, linked Zofran with a 2.4-fold increased risk of cleft palate.
After over 30 years without an FDA-approved drug for morning sickness, last year the FDA approved Diclegis — classified as a “Pregnancy Category A” medication. The safety of Diclegis is well-established in dozens of studies involving over 250,000 pregnancies. In comparison, Zofran is a “Pregnancy Category B” medication that is not approved for morning sickness.