SWHR calls for warnings for pregnant/lactating women on Rx labeling

8/25/2008

WASHINGTON The Food and Drug Administration should require all prescription drug and biological products to inform pregnant and lactating women of the potential risks to themselves and their fetuses or babies that the products may pose, the Society for Women’s Health Research said in a statement Thursday.

The society said that fetal risk summaries should appear first in the pregnancy subheading of drug labels and should include short- and long-term side effects and reflect the severity of the condition for which the drug is prescribed.

The society also proposed enhancing pregnancy exposure registries, which monitor the outcomes of pregnancies exposed to certain medical products, and more research to examine the levels and effects of drugs in breast milk.

“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 healthcare outcomes,” President and chief executive officer Phyllis Greenberger and vice president of public policy Martha Nolan said in a joint statement.

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