Fen-Phen

Fenfluramine and phentermine are anorectic agents individually approved by the United States Food and Drug Administration. The drugs used in combination may yield equivalent efficacy in weight reductions at lower doses of each agent and with fewer reported side effects. In 1996, the total number of prescriptions in the United States for fenfluramine and phentermine exceeded 18 million.

Source: CNN,“Valvular heart disease associated with fenfluramine-phentermine��?, Health Story Page, 1997, http://www.cnn.com/HEALTH/9707/08/fenphen.report/ (30 May 2007)

Warnings:

As of 6/8/1997 the FDA notifies the medical community of recent reports of valvular heart disease in women treated for obesity with a combination of fenfluramine and phentermine. There have been 33 cases reported of unusual valvular morphology and regurgitation involving the mitral, aortic, and/or tricuspid valves, usually being multivalvular. The histopathology of the diseased valves resembled that seen in carcinoid syndrome or ergotamine toxicity. Six patients have required surgical intervention. Health care practitioners are reminded that the safety and effectiveness of the combined use of fenfluramine and phentermine have not been established. FDA recommends if practitioners choose to use these products in a manner different than the approved labeling that they should follow patients closely with thorough cardiac evaluations.

FDA Public Health Advisory: http://www.fda.gov/cder/news/phen/phenfen.htm

As of 8/27/1997 the FDA strengthens its recent public warning that the use of a combination of fenfluramine and phentermine in the treatment of obesity has been associated with the development of serious cardiac disease. The agency has requested the manufacturers of phentermine, fenfluramine, and dexfenfluramine stress this potential risk in a black box warning in the drugs' labeling and in patient package inserts.

Source: U.S. Food and Drug Administration, “PHEN / FEN (phentermine & fenfluramine)��?, The FDA Saftey Information and Adverse Event Reporting Program, 1997, http://www.fda.gov/medwatch/SAFETY/1997/safety97.htm (30 May 2007)