The anti-nausea drug Zofran is often taken “off-label” to treat morning sickness in pregnancy, but recent studies have found evidence of birth defect risks. Zofran has also been linked to pregnancy risks that could be fatal for the mother, including serotonin syndrome and irregular heart rhythm.

Serotonin Syndrome

Because Zofran works by influencing serotonin, the FDA has issued a warning about serotonin syndrome.

Early diagnosis of serotonin syndrome is essential because it can be fatal if not treated. The FDA called this “potential safety issue,” but said no causal relationship has been established.

Even so, many pregnant women suffer from depression and also use antidepressants. The most popular antidepressants, SSRIs, work by influencing serotonin. It is possible that pregnant women on Zofran and an SSRI could develop side effects.

Symptoms of serotonin syndrome:

  • Agitation
  • Confusion
  • Fast heartbeat
  • Muscle twitching or stiffness
  • Fever
  • Loss of consciousness
  • Coma

Heart Problems and Sudden Death

Pregnant women with the most serious form of morning sickness, Hyperemesis gravidarum, develop severe nausea, vomiting, weight loss, dehydration, and electrolyte disturbances.

Electrolyte disturbances can also increase the risk of heart rhythm disorders, and so can Zofran. In June 2012, the FDA issued a Safety Communication about a heart rhythm disorder known as QT Interval Prolongation, which can worsen into Torsades de Pointes and sudden death.

In December 2012, the 32-mg intravenous (IV) dose of Zofran was recalled due to cardiac risks.

Signs of an irregular heart rhythm:

  • Palpitations (feeling a fluttering heartbeat)
  • Pounding in the chest
  • Dizziness
  • Light-headedness
  • Fainting
  • Shortness of breath
  • Chest pain
  • Weakness

Birth Defects

The Clark Firm, LLP is investigating potential lawsuits involving:


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