Zofran Spina Bifida

Published on March 5, 2015 by Sandy Liebhard

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Was your baby born with spina bifida? If you were treated with Zofran to control nausea and vomiting during your pregnancy, the medication may be to blame. A growing body of research has suggested that exposure to Zofran during the first trimester may increase the chances that a baby will be born with serious birth defects. A number of Zofran lawsuits have recently been filed in U.S. courts that accuse GlaxoSmithKline of not only concealing information that indicated the drug could harm a developing fetus, but which also claim that the company heavily promoted its use in expectant mothers, even though Zofran has never been approved to treat nausea and vomiting associated with pregnancy.

The nationwide law firm of Bernstein Liebhard LLP is investigating the possible connection between Zofran and spina bifida. If you believe this drug caused your baby to develop a serious neural tube birth defect like spina bifida, please contact our office today to learn more about the legal options that might be available to you.

Zofran and Birth Defects

Zofran is an anti-nausea medication used to treat patients undergoing certain cancer treatments, as well as post-operative surgery patients. Zofran has never been approved to treat nausea and vomiting related to pregnancy, and the U.S. Food & Drug Administration (FDA) currently classifies the medication in Pregnancy Category B. This category indicates that a drug has not been subjected to adequate and well-controlled studies involving pregnant women.

zofran spina bifidaIn 2014, the Toronto Star reported that 20 Canadian women who had been treated with Zofran or a generic version of the medication during pregnancy had given birth to babies with serious problems, including heart defects, kidney malformations, and musculoskeletal defects. In 2012, researchers with the U.S. Centers for Disease Control’s (CDC) National Birth Defects Prevention Study found that expectant mothers who used Zofran during the first trimester of pregnancy were more than twice as likely to give birth to baby with a cleft lip or cleft palate. The following year, Danish scientists looking at more than 900,000 pregnancies included in a Denmark health registry concluded that Zofran use in the first trimester was associated with a 30% increase in the risk for birth defects.

What is Spina Bifida?

Spina bifida is a neural tube defect that affects between 1,500 to 2,000 of the more than 4 million babies born in the U.S. every year. The condition occurs when the neural tube that will eventually become a baby’s brain and spinal cord fails to close, resulting in the incomplete development of the spinal cord, brain or the meninges (the protective covering around the brain and spinal cord). These defects occur very early in pregnancy, as the neural tube should be closed by the 28th day of gestation.

There are four types of spina bifida:

  • Occulta: This occurs when one or more of the vertebrae of the spine are malformed, but the opening on the vertebrae is covered by a layer of skin. Spina bifida occulta is the most common form, and also the mildest. It generally does not result in disability or symptoms.
  • Closed neural tube defects: This form of spina bifida occurs when the spinal cord is marked by malformations of fat, bone, or meninges. Severity can vary, with some baby’s experiencing no symptoms, while others may experience incomplete paralysis with urinary and bowel dysfunction.
  • Meningocele: Meningocele spina bifida occurs when spinal fluid and meninges protrude through an abnormal vertebral opening. The opening may or may not be covered by skin. Some children with this form of spina bifida experience no symptoms, while others may have partial paralysis and related bowel and urinary dysfunction.
  • Myelomeningocele: This is the most severe form of spina bifida, and occurs when the spinal cord/neural elements are exposed through the opening in the spine. A baby with myelomeningocele will experience complete paralysis below the opening. These babies may also experience urinary and bowel dysfunction, and they may be unable to walk.

There is no cure for spina bifida. Those with the mildest forms often need no treatment, but a baby with myelomeningocele will need to undergo surgery in the first days of life to close the opening and prevent infection from developing in the exposed nerves and tissue. Some children will need additional surgeries to deal with complications affecting the feet, hips, or spine, while those who develop hydrocephalus due to spina bifida will have to undergo surgeries to replace their shunt as they grow.

Think Zofran Caused Your Baby’s Spina Bifida? Contact an Attorney Today.

You could be entitled to compensation if you were treated with Zofran and your baby was born with spina bifida. The attorneys and legal staff at Bernstein Liebhard LLP have helped thousands of people injured by defective drugs and other products recover damages from those responsible. To learn how they can help you pursue a Zofran spina bifida claim on behalf of your child, please call to arrange for a free case review.

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