FDA seeks labeling for drugs' effects on pregnancy, lactation
NEWS IN BRIEF — Posted June 16, 2008
The Food and Drug Administration has issued a proposed rule that would scrap from prescription drug labeling the letter categories indicating a pharmaceutical's possible risk to a fetus. Instead, labels would have sections with headings such as "fetal risk summary," "clinical considerations" and "data" included in the pregnancy and breastfeeding text. Information also would be added about relevant pregnancy exposure registries.
The hope is that these changes will ease prescribing decisions and improve counseling of women who are pregnant or could become so while taking a drug.
Comments can be submitted to the agency until the end of August and will be taken into account before the final rule is issued.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2008/06/16/hlbf0616.htm.