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Zofran Side Effects

ATTENTION, WOMEN WHO HAVE USED THE DRUG ZOFRAN DURING PREGNANCY

Zofran used during pregnancy for morning sickness or nausea has been linked to serious birth defects in children. If you or a loved one took Zofran while pregnant, you and your child may be entitled to financial compensation.

ZOFRAN BIRTH DEFECTS

Our law firm has been investigating the link between Zofran taken for morning sickness during the first trimester of pregnancy and serious fetal injuries. We believe there is now strong evidence that Zofran (ondansetron) may be the cause of these defects.

Zofran Birth Defects Research

A Safety Communication was issued by the FDA in September 2011 stating that the 32mg dose of Zofran may “increase the risk of developing abnormal changes in the electrical activity of the heart, which can result in a potentially fatal abnormal heart rhythm.”

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The manufacturer of Zofran, GlaxoSmithKline, conducted an FDA-ordered trial to study those risks through January 2012. Shortly thereafter, the FDA issued another Drug Safety Communication which stated that preliminary results showed:

  • Electrocardiogram (ECG) changes including QT interval prolongation
  • Torsade de Pointes, or an abnormal and potentially fatal heart rhythm
  • Elevated risk in patients with congenital long QT syndrome
  • Congestive heart failure
  • Bradyarrhythmias
  • Or those who were taking additional medications that have been known to cause QT interval prolongation

Healthcare practitioners were warned by the FDA not to use the 32 mg dose of Zofran. Zofran was ultimately recalled.

ZOFRAN RECALL AND HISTORY

The FDA has asked brand name and generic drug manufacturers to recall their version of GlaxoSmithKline’s 32 mg dose of Zofran (ondansetron).

In 1991, the FDA approved Zofran to treat chemotherapy-related nausea and later expanded that approval to treat PONV, or postoperative nausea and vomiting. Many pregnant women were prescribed Zofran to alleviate severe nausea symptoms.