Document Detail

FDA labeling system for drugs in pregnancy.
MedLine Citation:
PMID:  11724104     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To review the current Food and Drug Administration (FDA) pregnancy labeling system, examine the new FDA-proposed pregnancy labeling system for form and content, and provide comments on its suitability for implementation. DATA SOURCES: Data were obtained from the FDA's Web site (, PubMed, Federal Register, LexisNexis, Physician's Desk Reference (PDR), Drugdex, and Current Contents. STUDY SELECTION: Research and articles involving drugs and pregnancy, drugs and lactation, and the subcommittee meeting of the FDA were included. DATA EXTRACTION: Prospective, case-control studies from pregnancy registries. DATA SYNTHESIS: Currently, only 40% of drugs in the PDR have pregnancy categories listed. The medical profession has resorted to other means to assess pregnancy risk, such as retrospective chart review, case reports, and consultation with experts such as regional drug information centers. CONCLUSIONS: The proposed pregnancy labeling system strives for more clinical usefulness by reliance on human data derived from pregnancy registries. The clinical usefulness of the new labeling remains to be seen.
L A Boothby; P L Doering
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  The Annals of pharmacotherapy     Volume:  35     ISSN:  1060-0280     ISO Abbreviation:  Ann Pharmacother     Publication Date:  2001 Nov 
Date Detail:
Created Date:  2001-11-28     Completed Date:  2002-04-08     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  9203131     Medline TA:  Ann Pharmacother     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1485-9     Citation Subset:  IM    
College of Pharmacy, Auburn University, GA, USA.
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MeSH Terms
Drug Labeling*
Pregnancy / physiology*
United States
United States Food and Drug Administration
Comment In:
Ann Pharmacother. 2002 Apr;36(4):731-2; author reply 732   [PMID:  11936089 ]

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