News: Rx drug labels to change for pregnancy

July 1, 2008

The FDA proposed sweeping changes to physician labeling for prescription drugs and biologic products to provide more accurate information about using the agents during pregnancy and breastfeeding.

The Food and Drug Administration (FDA) recently proposed sweeping changes to physician labeling for prescription drugs and biologic products to provide more accurate information to both health-care professionals and their patients about using the agents during pregnancy and breastfeeding.

The hope is that by changing physician labeling, the information will trickle down to women either through package inserts and medication guides or directly through conversation.

The proposed rule would remove the letter category system now in use and replace it with a new pregnancy section on the label that would have three subsections. The first, called the "Fetal Risk Summary," would describe what is known about the effects of the drug on the fetus, including whether the information comes from human or animal studies. The second section called "Clinical Considerations" would include available information about the effects of the agent if it is used before a woman knows she is pregnant. And the third section called "Data" would describe in greater detail studies used to provide information for the "Fetal Risk Summary" section.

FDA proposes new rule to provide updated information on the use of prescription drugs and biological products during pregnancy and breast-feeding. Http:// http://www.fda.gov/bbs/topics/NEWS/2008/NEW01841.html. Accessed 5/28/08.