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U.S. Government Agency Warns That Zofran Can Cause Birth Defects

Women who suffer from morning sickness often turn to anti-nausea medications to help them nurture their babies. But according to the U.S. Food and Drug Administration (FDA), one drug manufacturer was actually putting unborn children at risk.

Zofran and Its Safety RisksZofran, or ondansetron, was created to be prescribed to cancer patients, helping them to eat normally by easing nausea and preventing vomiting. The anti-nausea medication was so successful that the drug’s manufacturer, GlaxoSmithKline, began marketing the drug to pregnant women for treatment of morning sickness.

However, GlaxoSmithKline did not have approval from the FDA before recommending the drug for use in pregnant patients. The medication has since been linked to health problems in the mothers and birth defects in their infants, including:

  • Heart defects – Such as atrial and ventricular septal defects (holes in the heart).
  • Mouth deformities – Such as cleft lip and cleft palate.
  • Jaundice – Yellow discoloration of a newborn’s skin and eyes due to infant liver problems.
  • Clubfoot symptoms – Including smaller or underdeveloped feet, turned-in feet, or other unusual foot positions that prohibit walking.
  • Craniosynostosis – This condition occurs when the bones of your baby's skull fuse prematurely, resulting in skull deformities, mental development, and vision problems.

What Is the Government Doing About These Drug Safety Risks?

Although the FDA has issued warnings about potential side effects for mothers taking Zofran, many doctors still prescribe the drug to pregnant women to combat severe morning sickness. To make matters worse, pregnant patients are likely to be offered Zofran in their first trimester—a key development period in an infant’s life—when nausea symptoms are most severe.

The FDA has not issued a recall on Zofran, nor prohibited doctors from prescribing the drug to any patients. The government agency only requires doctors to inform pregnant women of the known risks associated with Zofran before prescribing it.

If you were not warned about Zofran’s ability to cause birth defects or injuries during pregnancy, you should speak with an attorney as soon as possible to join the lawsuit against GlaxoSmithKline. Complete a contact form to schedule a free consultation or call Wayne Wright LLP today at 800-237-3334 to find out if you are eligible for payment for the injuries to your family.