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Zofran and Birth Defects

Probably the most famous case of morning sickness in recent years is that of the Duchess of Cambridge, Kate Middleton, when she was pregnant with Prince George in 2012. Middleton's severe morning sickness, known in medical circles as Hyperemesis Gravidarum, put her in the hospital for treatment - a scenario well-known to women all around 

the world suffering the same fate.

Morning sickness in its various forms can range from light to severe, and can happen at any time of the day, not just in the morning. But it is the severe form that is most dangerous to women and the unborn. When a pregnant woman cannot keep even fluids down, there is danger of dehydration and poor nutrition, and it is this condition that prompts many to seek medical attention. Doctors have a number of treatments at their disposal for use in combating severe morning sickness, but one medication has prompted closer examination due to an increased risk for birth defects.

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The Use of Zofran to Treat Severe Morning Sickness

Zofran was approved by the FDA in 1992, and marketed as an anti-nausea drug to treat the side effects of chemotherapy, radiation therapy, and surgery. Zofran (generic name: ondansetron) belongs to a class of drugs known as 5-HT3 receptor antagonists, which block serotonin, a chemical produced naturally by the human body that can cause nausea and vomiting. Though the medical establishment has adopted Zofran as a treatment for morning sickness, it is not approved by the FDA for this use. Even though there have not been sufficient studies to indicate that Zofran is safe for use by pregnant women, its manufacturer, GlaxoSmithKline (GSK) marketed the drug off-label as a treatment for expectant mothers experiencing nausea.

Increased Risk of Birth Defects Caused by Use of Zofran

In 2013 the FDA issued a warning regarding Zofran, based on studies that showed increased risk of heart defects such as Atrial Septal Defect, Ventricular Septal Defect, and heart murmur, as well as cleft palate or cleft lip, in the developing fetuses of women who took Zofran during the first trimester of their pregnancy.

A Three Billion Dollar Settlement

In 2012, GSK settled allegations of bribes and kickbacks with the U.S. Department of Justice for a number of their branded drug products, including Zofran. The pharmaceutical giant was ordered to pay up the $3 billion to resolve its criminal and civil liability in the promotion of certain prescription drugs as well as failure to report certain safety data.

Did You Take Zofran for Nausea in the First Trimester?

If your child was born with a congenital heart defect such as Atrial Septal Defect, Ventricular Septal Defect, or heart murmur, or was born with a cleft palate or lip as a result of taking Zofran to combat severe morning sickness in the first trimester, you may have a claim against GSK. An attorney with experience in pharmaceutical products liability can help you understand your legal rights. Contact Gerling Law for a free case review.

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