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Zofran Birth Defects: The FDA

By Andrew Sullo


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In 2013 the FDA issued an updated warning for the drug Zofran (Ondansetron) when used off-label for extreme morning sickness. The drug, manufactured by GlaxoSmithKline, is a 5-HT3 receptor which gained Zofran FDA approval in 1991 for the treatment of nausea and vomiting among patients undergoing chemotherapy, radiation and some surgeries.  The Zofran FDA warnings cautioned against the use of Zofran during pregnancy due to studies which tied the drug to birth defects such as congenital cardiac malformations and cleft lip and palate. Approximately 10-15% of pregnant women experience morning sickness so severe they receive drugs to treat the nausea and vomiting. Many doctors have prescribed Zofran off-label to these women during the first trimester. The first trimester is the time most women experience morning sickness—and also the time the fetus is most vulnerable to developing birth defects.

 

Off-Label Use of Zofran

Doctors are legally and ethically allowed to prescribe off-label drugs, however in this particular case GlaxoSmithKline actively promoted Zofran for use in pregnant women with morning sickness—a use not approved by the FDA due to lack of studies in pregnant women. Only one study, involving fewer than 200 pregnant women was done by GSK, yet they continued to promote the drug. In 2012 Glaxo paid the U.S. Department of Justice a whopping $3 billion for misleading advertising regarding a number of drugs, including Zofran as a treatment for the nausea associated with morning sickness.

 

Zofran FDA Warnings and Zofran FDA Issues

No official Zofran FDA adverse event reports have been filed, although now that studies have tied Zofran to several types of birth defects, there could well be an influx of reports in the near future. Some of the Zofran FDA warnings and Zofran FDA issues include:

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·         In March, 1999, a Zofran FDA warning letter was sent to GlaxoSmithKline regarding marketing of the drug.

·         In December, 2006, the FDA approved generic versions of Zofran. In August, 2011, GSK began a study titled “A Randomized, Double-blind, Four-period Crossover Study to Investigate the Effect of Intravenous Ondansetron (Zofran)…on Cardiac Conduction…in Healthy Adult Subjects.” This study was meant to test the cardiac risks associated with Zofran. 

·         A month later, in September, 2011, the FDA issued Zofran Drug Safety Communication. This alert stated Zofran could potentially change the electrical activity in the heart, leading to an abnormal heart rhythm. The alert prompted label changes which warned those patients with congenital long QT syndrome to avoid the use of Zofran. GSK was ordered to conduct studies regarding QT syndrome at this same time. 

·         In January, 2012, the CDC’s Nation Center on Birth Defects and Developmental Disabilities published a report which stated Zofran taken during the first trimester of pregnancy could double the risk of a cleft palate birth defect.

·         In August, 2013, two articles related to birth defects associated with Zofran were presented at the ISP. The first paper concluded Zofran taken during pregnancy was not expected to significantly increase the risk of birth defects. The second paper, which covered more years and more pregnant women than the first, concluded the exact opposite. These conclusions stated twice the risk of cardiac malformations in babies whose mothers took Zofran while pregnant, specifically during the first trimester.

·         In July, 2014, American researchers reaffirmed that Zofran does cross the placental barrier during pregnancy in high concentrations.

·         In August, 2014, a Swedish study investigated Zofran birth defect risks. This study reported Zofran posed a significantly increased risk of cardiac septum defects in babies of mothers who took Zofran for morning sickness in the first trimester. 

 

When to Speak to a Zofran Birth Defect Lawyer

If your baby was born with birth defects related to the drug Zofran, you can potentially hold the manufacturer of the drug responsible for any negligence. Perhaps your baby suffered low birth weight, musculoskeletal issues, jaundice, cleft lip or palate or heart or kidney issues. If so, it could be advantageous for you to speak with a Zofran birth defect lawyer as soon as possible.

Parents of babies born with birth defects can face extremely high medical expenses. A Zofran lawsuit could potentially pursue compensation for those medical expenses. If Zofran caused your baby’s birth defect, it could be beneficial to speak with a knowledgeable Zofran Birth Defects Attorney.
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