Zofran

Zofran Birth Defect Claims

Cleveland Birth Defect Lawyers at Spangenberg Shibley & Liber LLP

Spangenberg lawyers have been investigating the link between Zofran taken for morning sickness during the first trimester of pregnancy and serious fetal injuries involving cleft lip, cleft palate, and congenital heart defects. As a result of our extensive investigation, we believe there is now strong evidence that Zofran (ondansetron) may be the cause of these defects.

The FDA never approved this drug for morning sickness and GlaxoSmithKline (GSK), the maker of this drug, paid a $2 billion settlement in a civil lawsuit that involved allegations that GSK illegally promoted its Zofran drug to be prescribed to expectant mothers. This settlement did not include payments for injuries suffered due to the use of Zofran. You and your child may be legally entitled to compensation for pain and suffering, medical costs, loss of income, emotional distress and other damages.

If you took Zofran while pregnant and your child has health defects, contact our attorneys as soon as possible. You may be eligible to hold GlaxoSmithKline accountable for their negligence and secure financial support for your family. Call (216) 600-0114 today for a free legal consultation, and we can investigate the circumstances of your child’s birth defect and whether Zofran was the cause.

Zofran Use Linked to Heart Defects in Infants

Swedish researchers published a study of 1,400 Zofran-exposed pregnancies (from 1998-2012) in the December 2014 edition of Reproductive Toxicology. It showed a two-fold increase in the risk of "hole in the heart" defects.

Zofran has been linked to the following heart defects:

Zofran Doubles Risk of Cleft Palate Birth Defects

In August 2013, researchers from Denmark presented a study that covered the years 1997 to 2010 and nearly 900,000 pregnant women. Of major concern, the study detected a 2-fold increased risk of cardiac malformations with Zofran leading to an overall increased risk of major malformations of 30%.

A study of 9000 pregnant women conducted by Birth Defects Research in 2012 showed that Zofran was linked to a 2.4-times increase in the risk of cleft palate or cleft lip birth defects.

Do I Have A Zofran Birth Defect Lawsuit?

Spangenberg Shibley & Liber LLP is currently accepting Zofran injury cases in all 50 states. If you or a loved one has taken Zofran and had a baby born with a birth defect, you should contact one of our Zofran lawyers at (216) 600-0114.

The FDA has asked brand name and generic drug manufacturers to recall their version of GlaxoSmithKline’s 32 mg dose of Zofran (ondansetron). In January 1991, the FDA approved Zofran to treat chemotherapy-related nausea and later expanded that approval to treat PONV, or postoperative nausea and vomiting.

On September 15, 2011, the FDA issued a Drug Safety Communication which stated that the 32 mg dose 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.”

The FDA warned healthcare practitioners not to use the 32 mg dose. GlaxoSmithKline conducted an FDA-ordered trial to study those risks until January 2012. Six months later, the FDA issued another Drug Safety Communication which stated that preliminary results showed:

  • Electrocardiogram (ECG) changes including QT interval prolongation;
  • Torsade de Pointes, a potentially fatal irregular heart rhythm, in some patients; and
  • Elevated risk in patients with congenital long QT syndrome,
  • Congestive heart failure,
  • Bradyarrhythmias

On December 4th, the FDA issued yet another Drug Safety Communication that announced the Zofran recall. Patients should seek immediate medical assistance if they suffer shortness of breath, dizziness, faintness, or irregular heartbeat while undergoing Zofran treatment.

If you've suffered injuries as a result of GlaxoSmithKline's failure to warn about potential cardiac risks, contact one of our Zofran lawyers for a free consultation at (216) 600-0114.

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