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FDA Proposes New Drug Labels for Pregnant Women

Date:5/28/2008

New drug labels would include three sections devoted to pregnancy and breast-feeding. The first section, called the "Fetal Risk Summary," would describe what's known about the effects of a drug on the fetus and whether the risk is based on results of animal studies or human studies.

The second section, called "Clinical Considerations," would include information about effects associated with the drug if it were taken before a woman knows she is pregnant. This section would also outline risks of the disease to the mother and baby, dosing information and how to address complications.

The final section, called "Data," would describe in detail the available information about the drug's use in humans and animals studies used in developing the "Fetal Risk Summary."

The breast-feeding section of the label would use the same format as the pregnancy section and provide information about using the drug while nursing, Kweder said.

The FDA began work on redesigning labels of prescription drugs' effects during pregnancy and breast-feeding in 1997. The proposed changes announced Wednesday will undergo a review process, with the agency receiving comments from various stakeholders. Once that review has been completed, the FDA will incorporate the comments and come up with a final version of the labels. This process could take up to one year to finish, officials said.

Once the rule takes effect, new drugs would have to conform immediately to the revised labeling standard, Kweder said. For older drugs, the label requirements would be phased in over time. It will take several years for all drugs to comply with the new label standard, she said.

More information

For more on prescription drugs and pregnancy, visit the U.S. Department of Health & Human Services.

SOURCES: May 28, 2008, teleconf
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