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Zachary Mandell
Zachary Mandell
Attorney • (401) 273-8330

Morning Sickness Drug Zofran Linked to Birth Defects

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New studies of the morning sickness drug Zofran indicate that the medication may increase the risk of birth defects and congenital malformations in the offspring of pregnant women who use the medication.

What is Zofran?

Zofran, approved by the FDA in 1991, is a medication developed by GlaxoSmithKline to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Zofran is also frequently prescribed for off-label use to treat morning sickness and hyperemesis gravidarum of pregnancy, although it is not approved for these uses.

Zofran and Birth Defects

FertilityCenter.com reports that, According to the FDA, taking Zofran during pregnancy can potentially lead to serious birth defects, yet many doctors continue to prescribe it during the first trimester of pregnancy, an infant’s most critical development period.

Since Zofran’s introduction in 1991, the FDA has received dozens of adverse event reports, most concerning the potential risk of birth defects connected to Zofran use. Some of the birth defects allegedly linked to Zofran include:

  • Congenital heart disease
  • Kidney malformations
  • Cleft lip
  • Cleft palate

According to a 2006 study published by Hong Kong Researchers in the International Journal of Obstetrics and Gynecology, Zofran “crosses the human placenta at high concentrations.” GlaxoSmithKline allegedly ignored the findings and continued to promote Zofran for use in pregnancy, despite the risks.

Zofran Lawsuits

Zofran lawsuits alleging that the medication may cause serious birth defects have been filed, claiming, among other things, that the drug’s maker knew of the risks but did nothing to warn consumers.

One such lawsuit was commenced on April 17 in U.S. District Court, District of Massachusetts by a woman who was forced to terminate her pregnancy after her unborn child was diagnosed with fluid on the brain, heart murmur, thickened arteries, and multiple developmental delays she alleges were caused by Zofran use.

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    Thank you for raising awareness about Zofran birth defects. It amazes me that this medication continues to regularly be prescribed to so many women during pregnancy.