Food and Drug Administration Center for Drug Evaluation and Research
Fen-Phen Safety Update Information
The statements included in the background documents below reflect FDA's perspective on fenfluramine and dexfenfluramine based on the information available in November 1997. As fenfluramine and dexfenfluramine are no longer marketed in the U.S. and have no current FDA labels, we refer you to the medical literature to stay up-to-date on the emerging research on this topic.
To make finding this information more convenient for you, we have formulated several search strategies that will search for the current literature in MEDLINE, one of the most comprehensive medical information systems in the world. MEDLINE is produced by the U.S. National Library of Medicine; its web version PubMed is updated daily and is free of charge. To obtain very comprehensive medical literature searches or searches on other topics, we recommend contacting the reference librarians in your local public or medical library.
The table below covers two search topics; you can limit each of these to literature in all languages or in English only. The time span columns limits the search to new records added to MEDLINE over the most recent number of days. To use this search application, read across the table to choose the search you prefer; run the search by clicking on the time span.
Fen-phen Update Searches on MEDLINE
If you have not previously used PubMed, be sure to visit PubMed Help for more information on searching MEDLINE.
Fen-Phen Interim Safety Recommendations
With the withdrawal of fenfluramine and dexfenfluramine from the US market, many people have asked what they should do if they have taken these drugs. In order to try to provide guidance, based on the best information known at present, the Centers for Disease Control and Prevention, the Food and Drug Administration, and the National Institutes of Health (all components of Department of Health and Human Services) collaborated with experts within the medical community to develop interim recommendations for patients. The interim recommendations were published in the November 14th issue of the Morbidity and Mortality Weekly Report (MMWR). This Fen/Phen information page includes these interim recommendations [11/13/97] and a series of questions and answers about the recommendations [11/13/97].
Other Fen-Phen Background Information
FDA/Center for Drug Evaluation and Research