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FDA
TALK PAPER
Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
T97-56 Marian Segal: 301-827-6242
November 6, 1997 Broadcast Media: 301-827-3434
Consumer Hotline: 800-532-4440
FDA WARNS AGAINST DRUG PROMOTION OF "HERBAL FEN-PHEN"
The FDA has become aware of the increasing promotion ofvarious dietary supplement-type products as "natural" herbal alternatives to the prescription drug combination commonly known as "fen-phen." So-called "herbal fen-phen" products are being marketed over the internet and through weight loss clinics, print ads and retail outlets as natural alternatives to the prescription drugs phentermine and fenfluramine (commonly referred to as "fen-phen"). FDA considers these products to be unapproved drugs because their names reflect that they are intended for the same use as the anti-obesity drugs, fenfluramine and phentermine.
The agency is warning consumers that these unapproved drugs have notbeen shown to be safe or effective and may contain ingredients that have been associated with injuries. Two anti-obesity drugs, fenfluramine (brand name Pondimin)and dexfenfluramine (brand name Redux), have been withdrawn from the marketplace because of safety concerns. FDA believes the use of unapproved alternative products may increase as a result of the withdrawal. Herbal fen-phen products contain none of these prescription drugs.
The main ingredient of most herbal fen-phen products is ephedra, commonly known as Ma Huang. Ephedra is an amphetamine-like compound with potentially powerful stimulant effects on the nervous system and heart. FDA has received and investigated more than 800 reports of adverse events associated with the use of ephedrine alkaloid-containing products since 1994. These events ranged from episodes of high blood pressure, heart rate irregularities, insomnia, nervousness, tremors and headaches to seizures, heart attacks, strokes and death. Many ephedra-containing herbal fen-phen products also contain Hypericum perforatum, an herb commonly known as St. John's Wort and sometimes referred to as "herbal Prozac." The actions and possible side effects of St. John's Wort have not been studied under carefully controlled trials either alone or in combination with ephedra.
Other herbal fen-phen products contain 5-hydroxy-tryptophan, a compound closely related to L-tryptophan, a dietary supplement widely used in this country until 1990. Used primarily as a sleep aid, L-tryptophan was pulled from the market after it was found to be linked to more than 1,500 cases, including about 38 deaths, of a rare blood disorder known as eosinophilia myalgia syndrome.
FDA regards any over-the-counter product commercially promoted as an alternative to prescription anti-obesity drugs (such as phentermine and fenfluramine) to be a drug. The agency is taking appropriate regulatory action to remove such products from the market.
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