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New Drug Labels for Pregnant Women Proposed by FDA

Filed May 29th, 2008 amy

On Wednesday the FDA proposed changes to that would detail potential health effects for pregnant and breast-feeding women, their fetuses or their newborns.

The proposed system would replace the current system that relies on letter designations to describe the risks of a drug when taken during pregnancy or breast-feeding. This system was deemed confusing and incomplete, according to a HealthDay News report.

“The system of letter categories has led to an inaccurate and overly simplified view of prescribing in pregnancy,” Dr. Sandra Kweder, deputy director of FDA’s Office of New Drugs, Center for Drug Evaluation and Research, said during the teleconference. “This system also makes it very difficult to update labeling as new information becomes available,” she added.

Under the new proposal, drug labeling would explain the potential benefits and risks for the mother, her fetus or her new baby, and how these risks change over the course of pregnancy, Kweder said.

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