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Study Links Use of Zofran During Pregnancy to Heart Defects

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Brian Finehout-Henry2 years ago

The National Birth Defects Prevention Network has reported that a study using Swedish registry data on births and prescription drugs has found that women who took ondansetron, generic name for Zofran, during pregnancy were significantly more likely to give birth to a baby with a heart defect.

Overview of Zofran

Zofran was developed by GlaxoSmithKline and received approval from the Food and Drug Administration, FDA, in January 1991. Zofran has only been tested for safety and approved for use in treating nausea and vomiting from cancer therapy and postoperative nausea and vomiting.

In June 2012 the United States Department of Justice announced that GlaxoSmithKline, also known as GSK, had agreed to plead guilty and pay $3 billion to settle charges that the company had illegally marketed prescription drugs, failed to report safety information, and other allegations.

The government had alleged that GlaxoSmithKline had illegally promoted Zofran for treating morning sickness during pregnancy, had distributed false information about the safety and effectiveness of Zofran for use during pregnancy, and paid doctors kickbacks for prescribing Zofran.

Zofran Significantly Increases the Risk of Heart Defects

The study published in the December 2014 edition of the journal Reproductive Toxicology found that ondansetron, which is the generic name of Zofran, used during early pregnancy was associated with a significant increased risk of the baby being born with a heart defect.

The study, examining over 1.5 million births from Sweden, found that use of ondansetron more than doubled the risk of the baby having a ventricular and/or atrial septal defect. The study reported the following cardiac defects when mothers used ondansetron during pregnancy:

  • Ventricular septal defect
  • Atrial septal defect
  • Pulmonary valve stenosis
  • Tetralogy of Fallot
  • Coarctation of aorta
  • Atrioventricular septal defects

The study focused on ondansetron used in early pregnancy because the heart is still forming and susceptible to chemicals causing birth defects during this stage of gestation.

Serious Heart Defects Linked to Zofran

The most commonly reported heart defects from the Swedish study were ventricular and atrial septal defects. University of Utah Health Care explains that ventricular and atrial septal defects are holes in the walls separately the different chambers of the heart.

The Centers for Disease Control and Prevention, CDC, reports that the following can be symptoms of an atrial septal defect:

  • Difficulty breathing
  • Difficulty feeding
  • Abnormal heart beats
  • Shortness of breath
  • Frequent lung/respiratory infections
  • Heart murmur
  • Swelling of limbs
  • Stroke

The CDC explains that there are several types of ventricular septal defects based on where the holes between the ventricles are located and that these septal defects can have the following symptoms:

  • Sweating
  • Poor feeding and tiredness with feeding
  • Shortness of breath
  • Poor weight gain
  • Abnormal breathing
  • Heart murmur

The Mayo Clinic explains that treatments for septal defects depend upon the severity of the condition and can range from monitoring to medications to open heart surgery.


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