Zofran Birth Defect Lawsuits

Zofran (Ondansetron), manufactured by GlaxoSmithKline, is an anti-nausea drug that is often prescribed to patients diagnosed with cancer who are undergoing chemotherapy and radiation therapy. The drug is also used to prevent nausea and vomiting after surgery. It is available in tablet and injectable form.

While Zofran earned FDA approval in 1991 for the treatment of nausea and vomiting in cancer patients, some doctors have also prescribed Zofran for off-label use to pregnant women who suffer from morning sickness. Recently, this off-label use has raised some concerns due to a lack of clinical trial data related to the drug’s effects on a fetus.

FDA issues drug safety communication regarding Zofran

The FDA issued a safety communication in September 2011 for patients who use Zofran. The communication warned that Zofran may be associated with potential fatal abnormal heart rhythms. These cardiovascular safety concerns came after the FDA reviewed studies which indicate a higher incident of electrical changes in the heart, also referred to as QT interval prolongation, in patients who take Zofran.

Birth defects and safety issues linked to off-label Zofran use

Zofran (ondansetron) has not been approved by the FDA for use in pregnant women. However, doctors have written off-label prescriptions for Zofran for pregnant women who suffer from nausea and vomiting. Recently, studies have been conducted to examine the effects of Zofran use in pregnant women.

The National Institute of Health published an article October 2012, that addresses concerns related to ondansetron use and various birth defects. Other studies have focused on the association between Zofran and:

  • Cleft lip
  • Cleft palate
  • Heart defects

The physician-author cites a study conducted by the Centers for Disease Control in Atlanta, Georgia, which indicated a 2-fold increased risk of cleft palate associated with ondansetron use for the treatment of nausea and vomiting during the first trimester of pregnancy.

Zofran birth defect lawsuits

In 2012, GlaxoSmithKline agreed to plead guilty to charges filed by the U.S. Department of Justice and settle civil charges alleging that it promoted Zofran and other drugs for off-label, non covered uses and paying kickbacks to doctors to prescribe those drugs. In total, GlaxoSmithKline agreed to pay $3 billion to resolve its criminal and civil liability.

Our product liability attorneys are interested in speaking with women who took Zofran while pregnant and gave birth to a baby who suffered from a serious birth defect such as cleft lip, cleft palate, or heart defect. If you or someone you know has taken this drug and delivered a baby with a serious defect, contact us. Cohen & Malad, LLP has litigated hundreds of claims against large pharmaceutical companies and medical device manufacturers and can provide you with a free case evaluation.

 

 
 
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