The Food and Drug Administration has proposed major revisions to the pregnancy and breast-feeding portions of drug labels, removing the simple letter system currently in use and replacing it with more detailed information. For instance, the new pregnancy risk section would include these three topics:

• Fetal risk summary, which would describe the drug's risks and the type of data (animal or human) used to assess risk.
• Clinical considerations, which would describe the effects of taking the drug before a woman knows she's pregnant, risks of the disease to mother and fetus, dosage information, ways to address complications, and whether a pregnancy exposure registry is available.
• Data, which would describe in more detail the data used to develop the fetal risk summary.

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