FDA Proposes New Drug Labels for Pregnant Women

By Steven Reinberg
HealthDay Reporter
Thursday, May 29, 2008; 3:00 AM

Copyright © 2008 ScoutNews, LLC. All rights reserved.

WEDNESDAY, May 28 (HealthDay News) -- U.S. health officials proposed Wednesday changes to the labels on prescription drugs that would detail potential health effects for pregnant and breast-feeding women, their fetuses or their newborns.

If enacted, the new system, proposed by the U.S. Food and Drug Administration, would provide doctors and pharmacists with more comprehensive information to guide them in their prescribing practices.

"The most important tool the FDA has to carry out its mission to protect and promote the health of every single American is the legal authority we've been given to determine the content and the format of labeling," FDA Commissioner Dr. Andrew C. von Eschenbach said during a teleconference.

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.

"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.

There are about six million pregnancies in the United States every year, and pregnant women take an average of three to five prescription drugs during pregnancy. Also, women with pre-existing medical conditions, such as asthma or high blood pressure, may need to use prescription drugs to treat those conditions during pregnancy, the FDA noted.

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.

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.