Several studies linked Zofran to a handful of birth defects and side effects for the mother, as well. Zofran works as a 5-HT3 receptor antagonist, which blocks excess serotonin in the brain. This is very effective for preventing feelings of nausea and vomiting, but it can cause significant side effects in people with an electrolyte imbalance.

Electrolyte imbalances are extremely common in pregnant women. A 2013 study found that

pregnant women who were prescribed the drug were commonly experiencing what’s known as Serotonin Syndrome, which can lead to changes in cognitive behavior and cause symptoms such as confusion, agitation, instability, neuromuscular changes, and even coma and death.

An initial study in 2012 by Sloan epidemiology unit and the CDC found that women who took Zofran in their first trimester were 2.4 times more likely to give birth to a child with a cleft palate. Subsequently, a second study of 900,000 Danish women found that pregnant women who took Zofran experienced a “two fold increased risk of cardiac malformations, leading to an overall 30% increased risk of major congenital malformations.” Out of 1,248 women, 58 of them who had taken the drug within their first trimester gave birth to a child with birth defects.

GlaxoSmithKline simultaneously released their own study, which stated the drug did not cause birth defects, but the study cannot be substantiated. Over one million women continued to be prescribed this drug every year. Since the reported findings, pregnant mothers continue to call in reports to Motherisk, a Canadian organization that handles concerns from pregnant mothers.

Maternal Side Effects of Zofran

zofran side effects

One of the major maternal side effects linked to Zofran is Serotonin Syndrome. This is caused by a disruption of serotonin in the brain. When the user is already suffering an electrolyte imbalance, which is very common in pregnant women, the 5-HT3 receptor antagonist further exacerbates the unbalanced levels of serotonin in the brain. This can cause a host of cognitive and neuromuscular side effects in the mother, including:

  • Agitation or restlessness
  • Confusion
  • Rapid heart rate and high blood pressure
  • Dilated pupils
  • Loss of muscle coordination or twitching muscles
  • Muscle rigidity
  • Heavy sweating
  • Diarrhea
  • Headache
  • Shivering
  • Loss of consciousness
  • Coma

Birth Defects Due to Zofran

birth defects due to sofran

Additionally, Zofran is linked to a handful of birth defects. Pregnant women who were prescribed the drug in their first trimester were found to have a twofold increased risk in giving birth to a child with a cleft palate and a 30% increase of risk in giving birth to a child with a heart defect. Some of the other reported birth defects are:

  • Musculoskeletal anomalies
  • Mouth deformities
  • Jaundice
  • Heart defects: including holes in the heart, heart murmur, and septal defects.
  • Intrauterine growth restriction
  • Kidney malformations
  • Death
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There are several lawsuits already filed against Glaxo Smith Kline & Zofran that you should know about.