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Home > QR-E-Letter Archive > 11-10-2005
Issue No. 19 November 10, 2005
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QUICK REFERENCE #29: The FDA Pregnancy Labeling Taskforce has expressed criticisms of and recommendations pertaining to the current “use-in-pregnancy” labeling categories for new drugs and biologic products. What are these criticisms and recommendations?
The FDA Pregnancy Labeling Taskforce has expressed the following 2 major criticisms:
(1) The current category system conveys the "incorrect impression that reproductive risk increases from category A to B to C to D to X." While criteria for inclusion in categories A through C "may reflect increasing risk," drugs in categories D, X, and in some cases C, "may pose similar risk, but be categorized differently on the basis of different risk/benefit considerations."
(2) "The categories create the impression, often mistaken, that the drugs within a given category present similar reproductive risks."
[See the October 27, 2005 issue of the QR-E-Letter for a summary of current pregnancy labeling categories. To view that issue, click on "QR-E-Letter Archive," located toward the top of this page.]
The FDA Pregnancy Labeling Taskforce has made several recommendations, including the following:
(1) "The current pregnancy letter category designations and accompanying text should be replaced by narrative text that is more informative and less prone to misinterpretation or misapplication.
(2) "The narrative text should provide more detailed clinical management advice than it presently does, including advice relevant to inadvertent fetal exposure."
(Note to The Complete Practitioner paid subscribers: You can access related content by conducting a search for "use-in-pregnancy labeling" in the Subscribers' Area of our Web site [http://www.completepractitioner.com].)
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