FDA proposes pregnancy and breast-feeding drug labeling changes

July 2, 2008

The US Food and Drug Administration (FDA) proposed major labeling revisions for prescription drugs taken during pregnancy and breast-feeding.

The US Food and Drug Administration (FDA) proposed major labeling revisions for prescription drugs taken during pregnancy and breast-feeding.

The changes aim to provide more complete information about the effects of these medications, enabling health care professionals to make more informed prescribing decisions and advice for women who are pregnant, breast-feeding, or are of child-bearing age.

The FDA has proposed that the pregnancy and lactation subsections of labeling include a risk summary that describes the medication risks to the fetus or breast-feeding infant, along with supporting data. Relevant clinical information for counseling pregnant or lactating women about prescribing and managing the use of these drugs would also be included.

"The proposed rule is intended to create a consistent format for providing information about the risks and benefits of medicine use during pregnancy and lactation," the FDA states on its website. "In doing so, the proposed rule would enhance well-informed decision making by healthcare practitioners and women of child-bearing age."

More information about the FDA's proposals can be found here.