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Liver damage from supplements (but more from drugs?)

MeSci

ME/CFS since 1995; activity level 6?
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8,231
Location
Cornwall, UK
Don't shoot the messenger!

Article in New York Times:

Spike in Harm to Liver Is Tied to Dietary Aids

By ANAHAD O’CONNOR
Published: December 21, 2013

When Christopher Herrera, 17, walked into the emergency room at Texas Children’s Hospital one morning last year, his chest, face and eyes were bright yellow — “almost highlighter yellow,” recalled Dr. Shreena S. Patel, the pediatric resident who treated him.

Christopher, a high school student from Katy, Tex., suffered severe liver damage after using a concentrated green tea extract he bought at a nutrition store as a “fat burning” supplement. The damage was so extensive that he was put on the waiting list for a liver transplant.

“It was terrifying,” he said in an interview. “They kept telling me they had the best surgeons, and they were trying to comfort me. But they were saying that I needed a new liver and that my body could reject it.”

New data suggests that his is not an isolated case. Dietary supplements account for nearly 20 percent of drug-related liver injuries that turn up in hospitals, up from 7 percent a decade ago, according to an analysis by a national network of liver specialists. The research included only the most severe cases of liver damage referred to a representative group of hospitals around the country, and the investigators said they were undercounting the actual number of cases.

While many patients recover once they stop taking the supplements and receive treatment, a few require liver transplants or die because of liver failure. Naïve teenagers are not the only consumers at risk, the researchers said. Many are middle-aged women who turn to dietary supplements that promise to burn fat or speed up weight loss.

“It’s really the Wild West,” said Dr. Herbert L. Bonkovsky, the director of the liver, digestive and metabolic disorders laboratory at Carolinas HealthCare System in Charlotte, N.C. “When people buy these dietary supplements, it’s anybody’s guess as to what they’re getting.”

Though doctors were able to save his liver, Christopher can no longer play sports, spend much time outdoors or exert himself, lest he strain the organ. He must make monthly visits to a doctor to assess his liver function.

Americans spend an estimated $32 billion on dietary supplements every year, attracted by unproven claims that various pills and powders will help them lose weight, build muscle and fight off everything from colds to chronic illnesses. About half of Americans use dietary supplements, and most of them take more than one product at a time.

Dr. Victor Navarro, the chairman of the hepatology division at Einstein Healthcare Network in Philadelphia, said that while liver injuries linked to supplements were alarming, he believed that a majority of supplements were generally safe. Most of the liver injuries tracked by a network of medical officials are caused by prescription drugs used to treat things like cancer, diabetes and heart disease, he said.

But the supplement business is largely unregulated. In recent years, critics of the industry have called for measures that would force companies to prove that their products are safe, genuine and made in accordance with strict manufacturing standards before they reach the market.

But a federal law enacted in 1994, the Dietary Supplement Health and Education Act, prevents the Food and Drug Administration from approving or evaluating most supplements before they are sold. Usually the agency must wait until consumers are harmed before officials can remove products from stores. Because the supplement industry operates on the honor system, studies show, the market has been flooded with products that are adulterated, mislabeled or packaged in dosages that have not been studied for safety.

The new research found that many of the products implicated in liver injuries were bodybuilding supplements spiked with unlisted steroids, and herbal pills and powders promising to increase energy and help consumers lose weight.

“There unfortunately are criminals that feel it’s a business opportunity to spike some products and sell them as dietary supplements,” said Duffy MacKay, a spokesman for the Council for Responsible Nutrition, a supplement industry trade group. “It’s the fringe of the industry, but as you can see, it is affecting some consumers.” More popular supplements like vitamins, minerals, probiotics and fish oil had not been linked to “patterns of adverse effects,” he said.

The F.D.A. estimates that 70 percent of dietary supplement companies are not following basic quality control standards that would help prevent adulteration of their products. Of about 55,000 supplements that are sold in the United States, only 170 — about 0.3 percent — have been studied closely enough to determine their common side effects, said Dr. Paul A. Offit, the chief of infectious diseases at the Children’s Hospital of Philadelphia and an expert on dietary supplements.

“When a product is regulated, you know the benefits and the risks and you can make an informed decision about whether or not to take it,” he said. “With supplements, you don’t have efficacy data and you don’t have safety data, so it’s just a black box.”

Since 2008, the F.D.A. has been taking action against companies whose supplements are found to contain prescription drugs and controlled substances, said Daniel Fabricant, the director of the division of dietary supplement programs in the agency’s Center for Food Safety and Applied Nutrition. For example, the agency recently took steps to remove one “fat burning” product from shelves, OxyElite Pro, that was linked to one death and dozens of cases of hepatitis and liver injury in Hawaii and other states.

The new research, presented last month at a conference in Washington, was produced by the Drug-Induced Liver Injury Network, which was established by the National Institutes of Health to track patients who suffer liver damage from certain drugs and alternative medicines. It includes doctors at eight major hospitals throughout the country.

The investigators looked at 845 patients with severe, drug-induced liver damage who were treated at hospitals in the network from 2004 to 2012. It focused only on cases where the investigators ruled out other causes and blamed a drug or a supplement with a high degree of certainty.

When the network began tracking liver injuries in 2004, supplements accounted for 7 percent of the 115 severe cases. But the percentage has steadily risen, reaching 20 percent of the 313 cases recorded from 2010 to 2012.

Those patients included dozens of young men who were sickened by bodybuilding supplements. The patients all fit a similar profile, said Dr. Navarro, an investigator with the network.

“They become very jaundiced for long periods of time,” he said. “They itch really badly, to the point where they can’t sleep. They lose weight. They lose work. I had one patient who was jaundiced for six months.”

Tests showed that a third of the implicated products contained steroids not listed on their labels.

A second trend emerged when Dr. Navarro and his colleagues studied 85 patients with liver injuries linked to herbal pills and powders. Two-thirds were middle-aged women, on average 48 years old, who often used the supplements to lose weight or increase energy. Nearly a dozen of those patients required liver transplants, and three died.

It was not always clear what the underlying causes of injury were in those cases, in part because patients frequently combined multiple supplements and used products with up to 30 ingredients, said Dr. Bonkovsky, an investigator with the network.

But one product that patients used frequently was green tea extract, which contains catechins, a group of potent antioxidants that reputedly increase metabolism. The extracts are often marketed as fat burners, and catechins are often added to weight-loss products and energy boosters. Most green tea pills are highly concentrated, containing many times the amount of catechins found in a single cup of green tea, Dr. Bonkovsky said. In high doses, catechins can be toxic to the liver, he said, and a small percentage of people appear to be particularly susceptible.

But liver injuries attributed to herbal supplements are more likely to be severe and to result in liver transplants, Dr. Navarro said. And unlike prescription drugs, which are tightly regulated, dietary supplements typically carry no information about side effects. Consumers assume they have been studied and tested, Dr. Bonkovsky said. But that is rarely the case. “There is this belief that if something is natural, then it must be safe and it must be good,” he said.
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
Silymarin (milk thistle extract) can also cause severe liver damage in some, even thought it is intended to treat liver damage. This is a complex area, and simplistic interpretations don't help. I think falsely adding substances or substituting substances to a health product should be severely treated under law, companies liquidated, individuals imprisoned. I do not think any reflexive banning or similar is a good idea though.
 

Bob

Senior Member
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16,455
Location
England (south coast)
In the UK there have been a number of reports of severe liver damage after using Chinese herbal supplements, and it seems to always be because the supplement was contaminated with banned substances. (These are the only cases I've read about in the media.) It's probably wise to buy from a well-known and reputable retailer, and/or buy well-known brands.
 
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Beyond

Juice Me Up, Scotty!!!
Messages
1,122
Location
Murcia, Spain
It all depends of what you are taking. Obviously this guy didn´t have luck, or sight to see that the fat burning pills where in fact liver-destructor pills. Bodybuilding and fat burning supplements are among the worst, but many chinese powders have LEAD and what not. There is a guy in the CureZone adrenal fatigue forum that got it in part because of bodybuilding supplements.

The most toxic and dumb stuff I have swallowed was Yohimbe Plus. It made my eyes bright red and gave me a nice headache with nausea. People told me I looked ill. In other ocassion coupled with beers it gave me a "high", that was pretty cool. It also had other effects that I don´t feel confident to share haha! Later I learned that Yohimbe is in fact pretty dangerous. I think that I had luck with these side effects considering at that time I was popping pills without any research.
 
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Messages
15,786
The most toxic and dumb stuff I have swallowed was Yohimbe Plus. It made my eyes bright red and gave me a nice headache with nausea. People told me I looked ill. In other ocassion coupled with beers it gave me a "high", that was pretty cool. It also had other effects that I don´t feel confident to share haha! Later I learned that Yohimbe is in fact pretty dangerous. I think that I had luck with these side effects considering at that time I was popping pills without any research.
Have you ever tried pure Yohimbe? I take a low dose (100mg) twice per day and it's been working great with no side effects. Pulse pressure can stay up at a normal level all day usually, constipation and muscle twitching is gone (I was able to stop taking magnesium twice per day) and body temp is closer to normal. It also seems to take the edge off of PEM.

Doses in supplements are all way too high, from what I've seen (400-450mg, versus 100). Also I stay away from the ones with extra crap added in, especially since I'm not interested in getting erections :wide-eyed: But prior to starting Yohimbe and after taking Strattera for over a year (for pulse pressure problems), my liver results were elevated. After switching from Strattera to Yohimbe, my levels went back to normal, though that might be coincidence.
 

GhostGum

Senior Member
Messages
316
Location
Vic, AU
Being typically cynical this comes across as a nice scare article in the FDA's continued push to ban the whole industry rather than regulating it properly. Alex is right, those who do the wrong thing should be heavily prosecuted and how hard is it for the FDA to be doing continual random testing of products and manufacturing processes? Although the endless stream of new products into the market can be problematic, that is why you do research and use things that have been around a long time.

And where is the information on what has actually happened to these people? What supplements? What circumstances? I wonder how many are very ill-informed people pumping designer body building supplements into their system.

Prescription drugs still account for many more deaths and complications than supplements by far so where is the FDA then scrutinizing those products and companies? Recent revelations about statins is a prime example and still many doctors pretend like they are perfectly safe, even some patients told the complications from the drug must be in their head; comical.
 

HowToEscape?

Senior Member
Messages
626
Drug vs Supplement.

Let's see:
Supplement:
Something said to have a physiologic effect on the body when administered, usually by eating or drinking it (ingestion). I'm not aware of any OTC injectable supplements, though they may well exist.

Drug:
"a medicine or other substance which has a physiological effect when ingested or otherwise introduced into the body."

I take an OTC supplement, SAM-e, which helps somewhat with my symptoms. It's also an ingredient in medicine my doc uses for the disease. SAM-e is found in your body, though I don't believe I've ever seen a SAM-e berry, fruit, or vegetable. Nor have I seen a vitamin root, a trace mineral berry or a DHEA tree. I also take other OTC supplements on occasion. Those supplements are not inspected or regulated; I have to take it on faith that the manufacturer is one of the few that actually places what's on the label in the supplement, in the amount advertised, and without lead, steroids, rat feces or other extras.

In sum, a supplement that does nothing is not a drug and is also safe.
A supplement that works is a drug.

....but if classified as a supplement it is not inspected and may be contaminated with lead, steroids, or animal feces as illustrated below.
------------------

In the US, the difference between a "supplement" and a "drug" is which legal box encloses it. If it is classed as a drug, it is FDA regulated. If it is classed under DSHEA, there is no regulation unless, after it has been on the market, it is found to be both a drug and harmful. The FDA does not have a budget to enforce that, unless a number of people obviously die or become disabled due to the supplement. This article illustrates what you goes on in the unregulated area:

http://www.newsday.com/news/health/...ment-companies-violate-agency-rules-1.5920525

Where anything goes, anything will show up.
 

heapsreal

iherb 10% discount code OPA989,
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Did they happen to mention how many hospitalised for liver disease from alcohol. They should look at reducing this before blamming supplements as they just make urine expensive.
 

GhostGum

Senior Member
Messages
316
Location
Vic, AU
By law, the FDA can't regulate supplements, so I don't think they can do testing and oversight they do for pharmaceuticals.

Is it really this straight forward? I had no idea the FDA had no ability to do random tests, they are actually not allowed to? Weird.

There really should be some independent body who conducts random tests on products and not just supplements, foods, cosmetics, white goods for toxins ect. With the current ability to genetically trace everything in a mass registry it should only be becoming easier to do as well with technology.
 

heapsreal

iherb 10% discount code OPA989,
Messages
10,089
Location
australia (brisbane)
Is it really this straight forward? I had no idea the FDA had no ability to do random tests, they are actually not allowed to? Weird.

There really should be some independent body who conducts random tests on products and not just supplements, foods, cosmetics, white goods for toxins ect. With the current ability to genetically trace everything in a mass registry it should only be becoming easier to do as well with technology.
They band supplements of tryptophan In the past so they must be able to step in somewhere? ?
 

GhostGum

Senior Member
Messages
316
Location
Vic, AU
They band supplements of tryptophan In the past so they must be able to step in somewhere? ?

That was when things went very ugly which turned out to be from contaminates. I would be surprised if the FDA can not randomly check products for issues or misleading contents but it just appears they are not proactive about it, instead just jump in like in this above story to make the whole industry look bad.

Maybe it is an expensive proposition but it is a worry if no one is keeping more of an eye on many consumer products.
 
Messages
10,157
http://www.webmd.com/fda/fda-101-dietary-supplements?page=2

How Are Supplements Regulated?

You should know the following if you are considering using a dietary supplement.

  • Federal law requires that every dietary supplement be labeled as such, either with the term "dietary supplement" or with a term that substitutes a description of the product's dietary ingredient(s) for the word "dietary" (e.g., "herbal supplement" or "calcium supplement").
  • Federal law does not require dietary supplements to be proven safe to FDA's satisfaction before they are marketed.
  • For most claims made in the labeling of dietary supplements, the law does not require the manufacturer or seller to prove to FDA's satisfaction that the claim is accurate or truthful before it appears on the product.
  • In general, FDA's role with a dietary supplement product begins after the product enters the marketplace. That is usually the agency's first opportunity to take action against a product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded.
  • Dietary supplement advertising, including ads broadcast on radio and television, falls under the jurisdiction of the Federal Trade Commission.
  • Once a dietary supplement is on the market, FDA has certain safety monitoring responsibilities. These include monitoring mandatory reporting of serious adverse events by dietary supplement firms and voluntary adverse event reporting by consumers and health care professionals. As its resources permit, FDA also reviews product labels and other product information, such as package inserts, accompanying literature, and Internet promotion.
  • Dietary supplement firms must report to FDA any serious adverse events that are reported to them by consumers or health care professionals.
  • Dietary supplement manufacturers do not have to get the agency's approval before producing or selling these products.
  • It is not legal to market a dietary supplement product as a treatment or cure for a specific disease, or to alleviate the symptoms of a disease.
  • There are limitations to FDA oversight of claims in dietary supplement labeling. For example, FDA reviews substantiation for claims as resources permit.
 

heapsreal

iherb 10% discount code OPA989,
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i know in australia they have checked the actual contents of supplements. I made an order from iherb, something very legite and they actually tested the tablets to make sure it was what was stated in the bottle and it was fine, but then the bastards tried to charge me $300 for doing the test, i told them to stick it as i didnt aske for the test and nothing illegal was found, they did say that i wouldnt get my supps until i payed for this fee. I told them to keep my $20 bottle of vitamins, i aint paying $300 for some test and i was innocent. ANother example how redsiculus our customs is and how lucky many other countries are.

Here in australia they wonder why the bikie gangs are running underground drug bussiness, its because they make everything here illegal, too many do gooders are uninformed about what is dangerous and what isnt.

I will give an example of whats happening here at the moment with the subject of steroids, big fines for personal possession and up and jail sentences. Once upon a time one would go to the doctor and get pharmact grade drugs and be monitored by a doctor if anything bad started to happen then jump on it early, funny thing most docs saw little health issues arising, then the govt closed all this up, so now its underground where people by steroids off bikie gangs probably brewed in buba's bath tub, also theres not ongoing monitoring of people using these drugs or how to use them properly. The govt and do gooders think they are doing the right thing but they just push everything underground as demand is still going up as are many health risks.

Its not just steroids but many types of drugs, the war on drugs is lost. legalise it all, tax it so then the govt get there money to pay for ongoing health issues of using these substances as well as educate people about there dangers. This for one takes the criminal elemant right out of it and they will all have to get real jobs and pay taxes and secondly it will help improve the health of these people using different substances as they wont be scared to ask for help and can be monitored regular and use clean drugs not brewed up in someones kitchen sink etc etc

It just makes sense to me, people should be allowed to do whatever they want to their bodies as long as it doesnt harm others eg driving under the influence etc. drugs, vitamins whatever used in moderation and not abused can be done safely. Making all these restrictions isnt doing a dam thing. Working in the health industry for over 20 years and without a doubt alcohol and smoking cause way more health issues then all the other crap combined, way more, but they dont really do a dam about that just the token thing to make it look like they are doing something.

Wow what a rant but thats how i see it.