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Zofran Risks for Pregnant Women


As evidence linking the use of Zofran during pregnancy with birth defects continues to grow, the FDA has also issued warnings about severe risks for the mother — including deadly irregular heart rhythms and serotonin syndrome.

Zofran Pregnancy Risks: Serotonin Syndrome

Zofran treats severe morning sickness by selectively blocking the 5-HT3 serotonin receptor in the brain, which increases gastric emptying and decreases the urge to vomit.

Because Zofran changes serotonin levels, the FDA believes there is a “potential safety issue” with serotonin syndrome, a life-threatening condition that is easily misdiagnosed and deadly without treatment.

The FDA did not specifically address this risk in pregnant women because Zofran is not approved or recommended during pregnancy. However, about 1 million pregnant women use Zofran every year. Many of these women are also taking SSRI antidepressants, which also change serotonin levels in the brain.

Women on SSRIs and Zofran should talk to a doctor about drug interactions and how to recognize symptoms of this dangerous pregnancy risk.

Serotonin Syndrome Symptoms

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

Zofran Pregnancy Risks: Irregular Heart Rhythm and Death

Extreme nausea and vomiting associated with the most serious form of morning sickness, known as Hyperemesis gravidarum, also causes weight loss, dehydration, and electrolyte imbalances in pregnant women.

Electrolyte imbalances interfere with electrical activity in the heart and cause irregular heart rhythm disorders — a deadly risk. Unfortunately, Zofran is also associated with a risk of heart rhythm disorders.

In June 2012, a Safety Communication was issued by the FDA to warn about QT Interval Prolongation, which is a drug-induced heart rhythm disorder that can lead to Torsades de Pointes.

These conditions can cause sudden cardiovascular death within minutes when the heart essentially stops beating and flutters ineffectively instead. Due to this risk, the FDA recalled 32-mg intravenous (IV) Zofran in December 2012.

Irregular Heart Rhythm Symptoms

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

Zofran and Birth Defects

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