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FDA requires warning labels on ephedrine

rwald

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http://www.cnn.com/2003/HEALTH/diet.fitness/02/28/ephedra.fda/index.html

HHS and the FDA said the labels would include warnings that the supplements can cause heart attacks, seizures or death.
...
The AMA said ephedra use is linked to heart attacks, strokes and seizures, among other conditions.

"I would not take this; I would not give it to my family. And I don't know why anyone would take these products," [Department of Health and Human Services Secretary Tommy ] Thompson said.
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On the TV version of same, the newscaster made a comment which somewhat worried me. He said that the FDA can only require that herbals be taken off the market if they are an "imminent danger to consumers." However, actual drugs are taken off the market with much less evidence (Phen-fen being an example). How do others feel about this state of affairs?
 
See also this thread, on a similar subject: FDA clamps down on Quack medicine producer

BillHoyt's post was most direct on this:

BillHoyt said:


They are prevented from doing so by two regulations: 1) The entire homeopathic pharmacopoeia was "grandfathered" long ago due to the influence of a senator who was a homeopath.* 2) DSHEA was passed some years ago that permits almost anything to be palmed off as a "dietary supplement" rather than a "drug." So long as they fly under the radar by wording their claims so that they don't look like claims, they escape FDA scrutiny.

Cheers,



*if I had said "homeopathic senator" people might have thought I meant he was diluted rather than deluded.**

** boy, I crack myself up.
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I had seen that thread, and considered posting this as a reply, but decided that it was different enough to warrent a new thread.
 
rwald said:
...the FDA can only require that herbals be taken off the market if they are an "imminent danger to consumers." However, actual drugs are taken off the market with much less evidence (Phen-fen being an example). How do others feel about this state of affairs?
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That whole Dietary Supplement and Food Act of 1994 pisses me off to no end. It allows anyone to put virtually anything into a bottle, call it whatever you want, and make just about any claim for it that you want. Pandora's box has been opened with this one. There are too many purveyors of this crap for the FDA to police all the claims with any kind of timeliness. Sad to say, but the only thing that will slow down the proliferation of this 21st Century snake oil is when victims and relatives of victims begin to sue the hell out of these companies. The sadder thing is that the courts and lawyers will want scientific proof that the supplement caused the death or illness even though no scientific evidence (let alone proof) was required for the company to be allowed to sell the product and make the wild claims in the first place! :mad:

Notice that now Stacker 2 comes in an ephedra-free variety. Yet they still sell the ephedra-laced variety!
 
We've had the same sort of think happen in the U.K. too.

Kava-kava, the herb used as a anxiolytic had been withdrawn several months ago due to liver toxicity, and has now been banned.

MCA Investigation

We have the same lame laws in the U.K. that protect sales of these types of products due to a loop-hole in the law.
They are all sold as "food suppliments" rather than herbal medicines, as medicines need research to prove that they work and aren't toxic.
It is odd that they group all herbal remedies as food. I've never heard of anyone having a deficiency in Sage or thyme!
 
this attack on ephedra is unwarranted. for one thing, the media keeps saying that around 100 deaths have been linked to ephedra (without mentioning a specific time frame) but lets put that in perspective:

(quoting from http://www.reason.com/links/links030303.shtml )

In 1999 alone, the government's Drug Abuse Warning Network reported 641 deaths linked to diphenhydramine (Benadryl), 477 deaths linked to the antidepressant Elavil, 427 deaths inked to acetaminophen (Tylenol), 305 deaths linked to Prozac, and 104 deaths linked to aspirin.
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check out the article for more info about why the case against ephedra doesn't stand up to scrutiny.
 
But Benadryl, Elavil, Tylenol, Prozac, and aspirin, have proven benefits for certain conditions. What proven benefits does ephedra have to justify taking risks with it? Do those benefits clearly outweigh the risks, as is usually the case for these other medications?

Your citation states "deaths linked to," which is not the same as deaths due to. "Linked to" may mean someone died in a car crash and happened to have a certain drug in his blood stream at the time of death.

Just to look at one particular example: your citation states 305 deaths have been "linked to" Prozac. The PDR reports that over 38 million people have been treated with Prozac. Of 1578 cases of overdose, alone or with other drugs, there were 195 deaths. Among 633 adults who overdosed on fluoxetine, 34 died.* No deaths are reported for persons taking Prozac at prescribed doses.

Anyone who tries to equate the lethality of ephedra to the lethality of Prozac is either grossly ignorant of the facts or very dishonest.

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*Because deaths are always reported and overdose events are not always reported, the actual lethality rate is even lower that the statistics above would indicate.
 
read the article. of the hundreds of deaths linked to ephedra, only two cases have been shown to have been due to ephedra. in terms of proven benefits, a study done on ephedra showed that it did have an effect on weight loss as compared to placebo. take that as you will, but as far as i'm concerned its up to the individual to weigh the benefits against the risks and make their own decisions. regarding your prozac statistics, do you mean to tell me that you can show that all deaths linked to or caused by ephedra involved the recommended dosage only? i am having difficulty seeing how attacking ephedra helps the cause of skepticism, or even makes any sense at all.
 
One of the main problems with so call "food suppliments" is that there are no proper laws governing whether they should be classed as therapeutic medicines.
If they are being used as a medicine or treatment, they should under go the same scrutiny of orthodox medicine.

The main reson ephedra has had bad press, is that it is a food, not a medicine. And taking herbs should not under reasonable circumstances kill anyone.

Lets get the herbal remedies on at least the same country as orthodox medicine, let along the same ball park and see how well they stand up to the scrutiny then.

Herbal remedies are not even declared in most cases. That skews the results enormously.

How many Doctors out there know what interactions are apparent with herbal remedies?

I asked many when working in a pharmacy for several years. The resounding answer was, " I don't think there is!". That is a damaging factor, if ever.
 
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