Zofran, Morning Sickness Drug, Linked to Birth Defects

December 9, 2014 — An investigative report by the Toronto Star has found evidence that Zofran, a powerful anti-nausea drug prescribed for morning sickness, is suspected of causing severe birth defects.

Zofran is approved to prevent nausea and vomiting in chemotherapy and surgery patients, but it is not approved for pregnant women. Many doctors prescribed it “off-label” to pregnant women, despite a lack of safety data.

Investigators analyzed Canadian side-effect reports filed wit the U.S. Food and Drug Administration (FDA) between 2010 and 2013. They found at least 20 women from Canada who used Zofran during pregnancy and had devastating outcomes, including:

• Two infant deaths
• Six babies had fetal growth restriction (IUGR), a condition in which the growth in the womb is below the 10th percentile for its age. Four of the babies weighed as little as 4-1/2 pounds.
• A baby born with a “musculoskeletal abnormality”
• A doctor reported that Zofran was the suspected cause of a baby’s mouth deformity, jaundice, heart murmur and two heart defects, including “atrial septal defect,” otherwise known as a hole in the heart.
• Multiple cases of newborns with heart defects and kidney malformations

The findings are concerning for several reasons. Recent studies have linked Zofran to a doubled risk of cleft palate. Other studies have linked Zofran with a doubled increased risk of heart defects, leading to a 30% increased risk of birth defects overall.

While only 1% of pregnant women have extreme morning sickness (hyperemesis gravidarium), about 10-15% report using a medication to treat symptoms. Zofran is one of the most popular medications, despite the fact that there are safer alternatives.

Last year, the FDA approved Diclegis for morning sickness. Diceglis is a “Pregnancy Category A” drug and its safety is well-established in dozens of studies involving more than 250,000 women. In comparison, Zofran is a “Pregnancy Category B” drug that is not approved for morning sickness.

The manufacturer of Zofran, GlaxoSmithKline (GSK), says Zofran is “not recommended” for pregnant women because so little is known about the risk of birth defects. However, in 2012, the Justice Department and GSK reached a $3 billion settlement for illegally marketing Zofran “off-label” to pregnant women with morning sickness and paying kickbacks to doctors who prescribed the drug.