Women's health group seeks FDA help in clarifying labels for pregnant or breast-feeding women

August 22, 2008

Goal is to identify potential health risks for these groups of women.

The Food and Drug Administration should mandate revised labeling on all prescription drug and biological products so that pregnant and lactating women are aware of potential health risks to them, their fetuses or nursing infants, recommended the Society for Women's Health Research to the agency via a public comment letter. The letter came as a response to the FDA's request for input on plans to modify drug labeling.

The Society, in Washington, D.C., suggests the proposed amendments are necessary to advance healthcare for pregnant or nursing women and their children.

"The requirements outlined in the proposed regulation will give pregnant and nursing women and their clinicians important and detailed information that will improve treatment decisions and health care outcomes," President and CEO Phyllis Greenberger and Vice President of Public Policy Martha Nolan said on behalf of the society.

The society is recommending that fetal risk summaries be noted first in the pregnancy subheading of drug labels. The risk information should include short- and long-term side effects and reflect the severity of the condition for which the treatment may be prescribed.

"Beyond labeling of current know risks, we need more research to understand how medical treatments affect pregnant women and their children," Greenberger said in a statement. "These groups have not been adequately studied in the past, so we can't conclude that research on medication use in the general population will apply to them."

The FDA will consider the comments in devising a report to Congress address the issue.

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