Zofran and the New FDA Rule on Warnings as to Pregnancy

Beginning on June 30, 2015, the FDA will have a new rule on labeling for certain drugs, including Zofran, as to certain categories including pregnancy. This new “final rule” also requires the removal of the previously discussed pregnancy categories A, B, C, D, and X from all drug product labeling.

The new “final rule” requires that the drug labeling include a summary of the risks of using a drug during pregnancy, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decision and counsel women about the use of drugs during pregnancy.

Under the “final rule,” the pregnancy section of the new labels must now provide information pertinent to the use of the drug in pregnant women, such as dosing and potential risks to the developing fetus, and will require information about whether there is a registry that collects and maintains data on how pregnant women are affected when they use the drug. This could include information on disease-associated maternal and/or embryo/fetal risk, dose adjustments during pregnancy, and maternal adverse reactions as well as fetal/neonatal adverse reactions.

The FDA believes that including such information supports health care providers’ understanding of drug product risks and benefits and facilitates informed prescribing decisions and patient counseling. The drug label must also describe the data that serve as the basis for the risk statements and clinical information included in the “pregnancy” section of the labeling.

For quite some time now, the FDA has recommended to drug companies—including GlaxoSmithKline (GSK) which makes Zofran—that they include in their labels the existence of any pregnancy registries and provide helpful information about them. GSK, however, has never voluntarily included such information in their labels. It is now required that the drug maker do so.

It is astounding that GSK has not changed its pregnancy labeling language for Zofran in any meaningful way throughout the 24 years that its product has been on the market. It is believed that GSK through its representatives in the field has encouraged the off-label use of Zofran to treat morning sickness in pregnancy even though the FDA has never approved it for this purpose. In time, Zofran eventually became the number one prescription drug in this country for the treatment of nausea and vomiting in pregnancy. How did this happen?


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