"Herbal Fen-Phen" FDA Action

[jikeda at socrates.berkeley.edu]

>>

>>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 of

>>various 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 not

>>been 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and dexfenfluramine (brand name Redux), have been withdrawn from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

>><strong>ephedrine</strong> 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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>Joanne P. Ikeda,MA,RD

>Nutrition Education Specialist & Lecturer

>Department of Nutritional Sciences

>University of California, Berkeley

>Berkeley, CA 94720-3104

>USA

>

>Phone (510)642-2790

>FAX (510)642-0535

>e-mail: jikeda at garnet.berkeley.edu

>

>

>

Joanne P. Ikeda,MA,RD
Cooperative Extension Nutrition Education Specialist
Department of Nutritional Sciences
University of California, Berkeley
CA 94720-3104

Phone (510)642-2790
FAX (510)642-0535
E-mail  jikeda at socrates.berkeley.edu