Drugs
Fen-Phen Safety Update Information
(fenfluramine, phentermine, dexfenfluramine)
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 on this topic in PubMed.
Fen-Phen Interim Safety Recommendations
[11/13/1997]
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 [11/13/1997] and a series of questions and answers about the recommendations [11/13/1997].
Fen-Phen Interim Safety Recommendations
MMWR- Cardiac Valvulopathy Associated with Exposure to Fenfluramine or Dexfenfluramine: U.S. Department of Health and Human Services Interim Public Health Recommendations, November 1997 (PDF - 118KB)Questions and Answers - Fenfluramine or Dexfenfluramine
November 13, 1997; Updated: July 7, 2005Information Requested for MedWatch Reports of Valvular Dysfunction
Other Fen-Phen Background Information
FDA Announces Withdrawal Fenfluramine and Dexfenfluramine (Fen-Phen)
9/15/97Questions and Answers about Withdrawal of Fenfluramine (Pondimin) and Dexfenfluramine (Redux)
9/18/97"Fen-Phen" Update (Fenfluramine, Phentermine, Dexfenfluramine)
8/28/97Public Health Advisory: Reports Of Valvular Heart Disease In Patients Receiving Concomitant Fenfluramine And Phentermine
7/8/97
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