Zofran: What is Pregnancy Category B?

Published on March 11, 2015 by Sandy Liebhard

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Zofran, a drug approved to prevent nausea and vomiting experienced by post-op surgery patients and those undergoing certain cancer treatments, has been placed in Pregnancy Category B by the U.S. Food & Drug Administration (FDA). But what exactly does this mean? In light of a growing number of legal claims involving alleged Zofran birth defects, this is an important question.

The FDA currently places prescription medications into one of five classifications, A through D and X. Pregnancy Category A includes drugs that have been subjected to adequate and well-controlled studies that have failed to show any evidence of fetal harm. Pregnancy Category X denotes medications for which there is evidence of human fetal risk, and the risks posed to pregnant women clearly outweigh potential benefits. The remaining categories fall somewhere in between these two extremes.

According to the FDA, Pregnancy Category B indicates that while animal reproduction studies have failed to demonstrate a risk to the fetus in regards to Zofran, there are no adequate and well-controlled studies in pregnant women. The drug’s label recommends that pregnant woman be prescribed Zofran “only if clearly needed.”

Is the Zofran Label Accurate?

Recently a number of Zofran lawsuits have been filed in U.S. courts that, among other things, dispute the accuracy of the pregnancy information included on the drug’s label. These claims, which were filed on behalf of children who were allegedly born with birth defects due to their mothers’ use of Zofran in their first trimester of pregnancy, point out that the medication’s Canadian label states that its safety for use in human pregnancy has not been established. It also advises that the use of Zofran in pregnant women should be avoided.

Zofran birth defect plaintiffs contend that the drug belongs in a higher Pregnancy Category, either D or X. They allege that in the 1980s, GlaxoSmithKline conducted animal studies which suggested, among other things, that Zofran could cross the placental barrier in pregnant mammals. They also claim that since 1992, the company has received hundreds of reports of children who were born with serious congenital abnormalities after their mothers were treated with Zofran during the first trimester of pregnancy.

Legal Help for Children Hurt By Zofran

If you believe your child could be the victim of a Zofran birth defect, you might be entitled to compensation from GlaxoSmithKline. To learn more about filing a Zofran lawsuit, please contact Bernstein Liebhard LLP today by calling

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