FDA Medical Bulletin Adverse Events with Ephedra and Other Botanical Dietary Su

[Guest guest]

FDA Medical Bulletin: Adverse Events with Ephedra and Other Botanical Dietary

Supplements

 

 

U. S. Food and Drug Administration

FDA Medical Bulletin

September 1994

 

 

 

Adverse Events with Ephedra and Other Botanical Dietary Supplements

FDA has been receiving increasing numbers of reports recently of adverse events

associated with the use of certain products marketed as dietary supplements for

weight loss, energy, and ergogenic (performance-enhancing) and body-building

purposes. These apparently diverse categories of products often contain a number

of similar ingredients, including Ma huang (Ephedra sinica or Chinese ephedra, a

botanical source of ephedrine, pseudoephedrine, and norpseudoephedrine), guarana

or Kola nut (caffeine sources), white willow (salicin source), and chromium.

They may also contain various amino acids, glandular products, or other

nutrients. They are touted for their reported stimulant effects (pep or energy)

and their ability to enhance metabolism with subsequent weight loss (so-called

" fat burners " ).

 

With the increased marketing and use of these products, FDA has received an

increasing number of reports of adverse reactions associated with their use.

These reported reactions vary from the milder adverse effects known to be

associated with sympathomimetic stimulants (e.g., nervousness, dizziness,

tremor, alternations in blood pressure or heart rate, headache, gastrointestinal

distress) to chest pain, myocardial infarction, hepatitis, stroke, seizures,

psychosis, and death. These adverse reactions have been reported both in young,

otherwise healthy individuals and persons with confounding or complicating

conditions such as hypertension. In addition, a stimulant " overdose " syndrome

has been reported in children and teenagers who have use these products.

 

Related weight-loss products often marketed as " dieter's or slimming teas "

contain a variety of strong botanical laxatives (Cassia species (senna), Cascara

sagada (botanical name Rhamnus purshiana)) and diuretics. Adverse reactions that

have been reported to FDA as associated with these products are characteristic

of those seen in laxative abuse syndromes, and include severe electrolyte

imbalances leading to cardiac arrhythmia and death.

 

FDA is concerned about the seriousness of these reported adverse events and

their increasing number. Because these products are commonly marketed as dietary

supplements, there is little or no premarket review by FDA of their safety (or

effectiveness), no good dosing information, and no monitoring advice.

 

FDA is interested in additional information on the adverse effects associated

with these products. We encourage health professionals to inquire about the use

of such products, including botanicals, as a routine part of the history-taking

process and to report serious adverse events associated with them through the

MedWatch Program.

 

 

 

 

 

--

 

This document was issued in September 1994.

For more recent information on Dietary Supplements

See http://www.cfsan.fda.gov/~dms/supplmnt.html

 

 

 

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[Guest guest]

-

" JoAnn Guest " <joguest

 

Friday, January 04, 2002 9:18 PM

FDA Medical Bulletin Adverse Events with Ephedra and

Other Botanical Dietary Su

 

 

> FDA Medical Bulletin: Adverse Events with Ephedra and Other Botanical

Dietary Supplements

>

>

> U. S. Food and Drug Administration

> FDA Medical Bulletin

> September 1994

 

I feel the FDA is crying wolf again. The FDA is so concerned with

bad effects of overuse when it comes to vitamins & herbals, but never with

scrip drugs, aspartame, etc. Which way the FDA rules in any circumstance is

predicated more on what big money wants a decision one way or the other than

on health issues. Yes, certainly, it is tempting to overuse stimulants.

I used to take a *lot* of ephedrine & pseudophed back when I used to go out

to clubs & dance all night. But I knew I was taking too much. My choice.

I learned to control my habit & finally give it up thru practical

experience. No need to the FDA to protect me from my own indiscretions.

 

Alobar

[Guest guest]

--- Alobar,

I posted the info for those who are using the weightloss

supplements. Many cable programs have had incidences where young

people are misusing this supplement, doing irreversible damage to

their bodies and at times losing their life. My daughter is one of

them.(she is determined to lost weight at any cost)! I do believe

that this is a very dangerous drug or herb whichever you want to call

it(it is widely used as both over the counter supplements and in

herbal form). Most of the cases were overdosages for the desired

effects, but I have heard that even with the prescribed amounts it

can be very fatal over a period of time.

Actually the information was for Mindy, who requested it earlier.

<grin>

JoAnn Guest

joguest

Friendsforhealthnaturally

 

" Alobar " <alobar@b...> wrote:

>

> -

> " JoAnn Guest " <joguest@m...>

> <Gettingwell>

> Friday, January 04, 2002 9:18 PM

> FDA Medical Bulletin Adverse Events with

Ephedra and

> Other Botanical Dietary Su

>

>

> > FDA Medical Bulletin: Adverse Events with Ephedra and Other

Botanical

> Dietary Supplements

> >

> >

> > U. S. Food and Drug Administration

> > FDA Medical Bulletin

> > September 1994

>

> I feel the FDA is crying wolf again. The FDA is so

concerned with

> bad effects of overuse when it comes to vitamins & herbals, but

never with

> scrip drugs, aspartame, etc. Which way the FDA rules in any

circumstance is

> predicated more on what big money wants a decision one way or the

other than

> on health issues. Yes, certainly, it is tempting to overuse

stimulants.

> I used to take a *lot* of ephedrine & pseudophed back when I used

to go out

> to clubs & dance all night. But I knew I was taking too much. My

choice.

> I learned to control my habit & finally give it up thru practical

> experience. No need to the FDA to protect me from my own

indiscretions.

>

> Alobar

[Guest guest]

-

" mrsjoguest " <joguest

 

Sunday, January 06, 2002 10:13 AM

Re: FDA Medical Bulletin Adverse Events with Ephedra

and Other Botanical Dietary Su

 

 

> --- Alobar,

> I posted the info for those who are using the weightloss

> supplements. Many cable programs have had incidences where young

> people are misusing this supplement, doing irreversible damage to

> their bodies and at times losing their life.

 

I have no problem with the warnings you posted. I am just

concerned about the FDA. The problem (IMO) is not with ephedrine, but with

its abuse. I am against the FDA sticking its nose into what I can buy or

how I may use it. I am not against FDA warnings, per se, but I have seen

many times when warnings preceed prohibition or restrictions. And that I am

against. Warnings also seem to do little good. How many people who abuse

ephedrine (for many different reasons) are going to listen? Not many, I

suspect. It is up to each one of us to choose what we put into our bodies,

and then bear the consequences of our decisions.

 

Alobar

[Guest guest]

--- Alobar,

Perhaps the FDA is concerned with the widespread abuse of Ephedra

among teenagers. Actually, like you say, if one is determined to

abuse weightloss supplements and it seems to be a common occurence

in this country, the information they're offering will not make much

of a difference. if they really wanted to limit it's use, they would

just pull it off the shelves, so in my mind there is little value in

publishing these reports if they don't take action.

I agree in that respect, the FDA should not be allowed to limit our

own personal choices in regards to supplements. I am totally against

that also. Actually at the moment I am more concerned about the vax

they are trying to impose on us as a country. Geez, now that's

interfering in our personal health choices I'd say.

Sometimes It seems like these government agencies are trying to

make a pretense of protecting the american people, while putting

other more important things such as the labeling of GMO's on the back

burner.

 

" Alobar " <alobar@b...> wrote:

>

> -

> " mrsjoguest " <joguest@m...>

> <Gettingwell>

> Sunday, January 06, 2002 10:13 AM

> Re: FDA Medical Bulletin Adverse Events with

Ephedra

> and Other Botanical Dietary Su

>

>

> > --- Alobar,

> > I posted the info for those who are using the weightloss

> > supplements. Many cable programs have had incidences where young

> > people are misusing this supplement, doing irreversible damage to

> > their bodies and at times losing their life.

>

> I have no problem with the warnings you posted. I am just

> concerned about the FDA. The problem (IMO) is not with ephedrine,

but with

> its abuse. I am against the FDA sticking its nose into what I can

buy or

> how I may use it. I am not against FDA warnings, per se, but I

have seen

> many times when warnings preceed prohibition or restrictions. And

that I am

> against. Warnings also seem to do little good. How many people

who abuse

> ephedrine (for many different reasons) are going to listen? Not

many, I

> suspect. It is up to each one of us to choose what we put into

our bodies,

> and then bear the consequences of our decisions.

>

> Alobar

[Guest guest]

JoAnn Guest wrote:

 

 

> Related weight-loss products often marketed as " dieter's or slimming teas "

contain a variety of strong botanical laxatives (Cassia species (senna), Cascara

sagada (botanical name Rhamnus purshiana)) and diuretics.

 

:/ Laxatives have not a thing to do with fat-burners!! I don't know why they

would be included in the same e-mail. But anyway...I agree that people with

heart problems should not take fat-burner pills.

 

> FDA is concerned about the seriousness of these reported adverse events and

their increasing number. Because these products are commonly marketed as dietary

supplements, there is little or no premarket review by FDA of their safety (or

effectiveness), no good dosing information, and no monitoring advice.

 

Hmph. Yet the FDA apparently has no problems with Meridia, which is similar to

fat-burners and has the *same* side effects. Hypocrisy, anyone?

 

I do think that one should be careful when taking ECA's, as far as paying

attention to any adverse symptoms, and taking electrolytes is *extremely*

important, because the caffeine excretes CMP big time (Calcium Magnesium

Potassium). When I first started taking ECA's, my body told me it needed

magnesium almost immediately...it was the strangest thing I've ever

experienced!! I started at one dose of ECA a day, then 2, then the full three

for about three days (too stimulating), back down to 2, and now down to one

again...I'm at a good weight now, so I could probably stop, but I'm worried that

I'll have a huge caffeine withdrawal and spend a couple days feeling like I got

run over by a truck. Eeep! :/

 

> FDA is interested in additional information on the adverse effects associated

with these products.

 

Yeah, I'll bet! How about the number of adverse effects associated with

aspirin? How about Effexor and all of those beloved prescription products? I

would like to find the database for adverse reactions so that I can compare the

# of reactions with various medications/supplements....

 

Mindy