New Drug Guidelines Proposed for Nursing/Pregnant Women

May 29, 2008

Revised physician labeling for prescription drugs to enhance safety information for use during pregnancy and breast-feeding have been proposed by the U.S. Food and Drug Administration. Although the changes are for information targeted at physicians, the same information is sometimes used in an adapted format for patients.

THURSDAY, May 29 (HealthDay News) -- Revised physician labeling for prescription drugs to enhance safety information for use during pregnancy and breast-feeding have been proposed by the U.S. Food and Drug Administration. Although the changes are for information targeted at physicians, the same information is sometimes used in an adapted format for patients.

The proposed new guidelines comprise three sections for both pregnancy and for breast-feeding: a fetal risk summary with a risk conclusion based on available data; a "clinical considerations" section summarizing implications for women who took the drug before they knew they were pregnant as well as information on dosing and complications; and a third section containing more detailed data from human and animal studies.

The impetus for the change grew out of dissatisfaction with the current labeling system, which critics warn may over-simplify the risks. The current system also makes it difficult to update labeling to incorporate newly available information.

"With this proposal, FDA's goal is to help women, their physicians and their pharmacists have better information about the effects of prescription medicines so that pregnant women, nursing mothers, and breast-feeding infants will benefit," said Rear Admiral Sandra Kweder, M.D., of the FDA's Center for Drug Evaluation and Research, in a statement. "This proposal would help make drug labeling a better communication tool, and would potentially have a huge impact on public health and well being for women."

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