The anti-nausea drug Zofran is not approved for the treatment of morning sickness. When it is used by pregnant women, studies suggest it may increase the risk of having a baby with a heart defect, cleft palate, or other serious birth defect.

Zofran Not Approved for Morning Sickness

Zofran is a popular “off-label” treatment for extreme morning sickness in pregnant women. Unfortunately, the fetal safety of Zofran was based on less than 200 births. It is also a “Pregnancy Category B” medication, which means the risk of birth defects in humans is unknown, but animal studies have not found evidence of risk.

Studies Linking Zofran and Birth Defects

In recent years, several studies have found evidence of potential fetal risks.

One study, published in Birth Defects Research in 2012, linked Zofran with a 2.4-fold increased risk of cleft palate. Babies who are born with this birth defect are missing the roof of their mouth. They may have trouble eating or need surgery.

Other studies have found evidence of heart defects. Six months after a study of 600,000 births found no evidence linking Zofran and birth defects, another study based on 900,000 births from the same registry linked Zofran with a doubled increased risk of heart defects, and a 30% increased risk of birth defects overall.

FDA Warnings: Maternal Safety Concerns

The FDA has also issued safety warnings for side effects of Zofran. These side effects can be life-threatening or fatal for a mother and her unborn child:

  • Serotonin Syndrome: Symptoms include confusion, agitation, rigid muscles, rapid heartbeat, high fever, seizures, and loss of consciousness.
  • Irregular Heart Rhythm: May lead to deadly cardiovascular events, such as Torsade des pointes
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