Cider vinegar supplement recall

rusty_blackhaw(6a)August 18, 2007

Cider vinegar (the "magical" supplement touted as therapy for a huge laundry list of medical conditions) is also promoted for weight loss. And it seems that one cider vinegar product might actually have been effective in doing that, only not in the way its users expected.

The cider vinegar supplement "MetaboslimTM" has been recalled after it was found that it had been adulterated with a prescription weight loss drug, silbutramine.

People unknowingly ingesting this drug were at risk of side effects including high blood pressure (which needs to be monitored in those prescribed silbutramine) and potentially harmful interactions with other meds.

This revelation follows other recent stories in which an "herbal sex pill" was discovered to contain the active ingredient in Cialis, and the recall of three red yeast rice supplements which had been adulterated with lovastatin, the basis for the cholesterol drug Mevacor.

Those who call for gutting the FDA's oversight functions in the name of "health freedom" might want to rethink their views on the safety of supplements.

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The red yeast rice supplements were not adulterated with lovastatin. They naturally contain it. The amount varies with the strain used. Charges of adulteration were not based on proof that any statin was added; it was based on the fact that there was a therapeutic level of statins, which the bureaucrats (erroneously) concluded must be from adulteration.

A serving of some types of common edible mushrooms can also contain more statins than a typical prescription pill.

Just another attempt by a pharmaceutical company to patent something that has been part of some diets for millenia, then use the legal system to shut down the low-priced natural producers.

Here is a link that might be useful: Production of Statins by Oyster Mushrooms

    Bookmark   September 8, 2007 at 12:33PM
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Traditional red yeast rice products contain a variety of bioactive chemicals. The one identical to lovastatin is normally present in much smaller amounts than was found in the companies' illegal supplements; so yes, the FDA concluded that these products were adulterated with the prescription drug lovastatin.

As noted here and recently in another thread with respect to many Chinese herbal products, a variety of supplements have been found to be adulterated with prescription drugs, to the point that their effectiveness is thought to be on the basis of the added drugs rather than the herbs.

In the case of lovastatin, these supplement markers are essentially supplying a drug dosage and promoting their products as being effective for lowering blood lipids and heart conditions; therefore they're not really selling supplements under the law, they're marketing drugs. Consumers don't know they're getting drugs, and are unable to protect themselves against possible side effects and drug interactions (some of which are possible with red yeast rice itself, but which pose added hazards with the adulterated red yeast rice). From PDR Health:

The use of red yeast rice for the management of hyperlipidemia must be medically supervised.

Those with a past history of liver disease and those who routinely use alcoholic beverages should exercise caution in the use of red yeast rice.

Lovastatin and other HMG-CoA reductase inhibitors occasionally cause myopathy. This is manifested as muscle pain or weakness associated with elevated levels of creatine kinase. Rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, has been reported rarely and can occur at any time. Those using red yeast rice should report promptly to their physicians unexplained muscle pain, tenderness or weakness.

Bleeding and/or increased INR values have been reported in a few patients taking warfarin concomitantly with lovastatin."

Users of either prescription lovastatin or red yeast rice also need to get their liver enzymes checked before and after starting on medication, to make sure they are not causing liver damage.

So while supplement makers and their defenders try to convince us that this is a "health freedom" issue, it's really about the FDA protecting us from unscrupulous and/or careless companies who put their profits ahead of patient safety.

    Bookmark   September 8, 2007 at 4:19PM
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Yes, myopathy and rhabdomyolysis are rare consequences of consuming statins. Although it could apparently be largely prevented if the statins were taken along with a CoQ10 supplement, which does not interfere with the effectiveness of the statins. And the most common cause of liver failure is acetominophen, which is available without a prescription. If risk and harm to the public were really the prime concern, things would be done differently. If freedom were not important, alcohol would be prohibited. Alcohol is the second leading cause of liver failure, and also contributes to thousands shootings, stabbings and auto fatalities each year. But we choose freedom anyway.

When the makers of Vioxx concealed data that it increased the risk of thrombus formation and heart attack, they induced 100,000 heart attacks, according to one group of doctors. Assuming 70% survival, that might mean the death of 30,000 people.

And you think you the real risk if from cider tablets? Or the herbal sex pills from a minor company in AUSTRALIA? I suppose that's your right. (BTW, the link you posted goes to an alert on baby cribs. Parents who allow their children to engage in the 'holistic or 'natural' practice of sleeping should be advised that many of the products being promoted by hucksters of dubious character and may actually kill their little ones. Please consult your doctor immediately if you allow your child to sleep. ;)

And I would like to know who makes threads in this forum sticky? Why is a forum ostensibly devoted to herbalism being so obviously manipulated by someone with a transparent agenda to spread fear and discredit herbalism??

    Bookmark   September 8, 2007 at 6:53PM
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Regarding what/who makes threads in this forum "sticky", I assume you're referring to unanswered threads staying at or near the top of the forum list. That's the way the forum works. As of earlier today, this and two other threads headed the list. Respond to a thread, and eventually (if there is no other interest) it'll start dropping down. There's no Secret Agenda involved.

And speaking of agendas, everybody can be claimed to have one. Vioxx, acetominophen and the perils of alcohol don't seem pertinent subjects to bring up in a forum devoted to herbalism. Adulteration of herbal and plant-based supplements is relevant to the purposes of the forum, as are various other subjects I bring up. Like this, which doesn't fit your "transparent agenda" theory.

apollog, I've appreciated your contributions to the forum thus far. You seem willing to cite sources for evidence-based herbalism, which is good. Falling back on personal attack when your arguments aren't accepted is not good, and is generally taken as a sign that one's arguments have failed.

    Bookmark   September 8, 2007 at 7:49PM
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All right - I've never seen a forum where unanswered threads stay at the top. But it does make sense, is actually a good idea in some ways. My apologies.

Yes, I think the perils of acetominophen and vioxx can be relevant when someone posts a thread that weaves together various minor risks from supplements and concludes "Those who call for gutting the FDA's oversight functions in the name of "health freedom" might want to rethink their views on the safety of supplements."

There can be risks from herbalism (or exercise or riding in a car), but those risks can only be understood in terms of the world of risk that we live in. Statistically, a person going out to vote is more likely to be hit by a car travelling to/from the poll than affect the results of a major election. Yet many of us choose to vote in spite of statistics that warn against it. We think that exercising the freedom to vote is worth the risks, even if some statistician decides it is not in our best interest.

I have no objections to discussing recalls - it is in the benefit of the people that participate here. I don't like dishonest manufacturers that adulterate their products. But I don't assume the FDA is always rational or fair or consistent; they weren't in the case of red yeast rice and oyster mushrooms. And I disagree with your conclusions. Patients should have freedom when it comes to their health.

    Bookmark   September 10, 2007 at 12:09PM
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The problem with saying that a risk is low at any given time (or that it is lower with some activities than with others) is that it hampers efforts to improve quality and safety.

The airline industry, for example, tells us that flying is statistically much safer than riding in a car, and quotes us a casualty rate of something like 0.0017 per 100,000 flights, or whatever. But they are smart and responsive enough to respond to problems in maintenance or security that affect that accident rate.

Comparisons made on behalf of the herb and supplement industry to mainstream medicine are often misleading, both because the latter deals with a much greater population of severely ill patients requiring complex and sometimes risky therapy. Problems associated with herbs and supplements are also underestimated because people often don't tell their physicians about taking them and connections between supplement use and complications/drug interactions aren't made.

"Patients should have freedom when it comes to their health."

I agree with this to a point. They also deserve freedom from exploitation by "caregivers", which includes unscrupulous, careless and/or greedy supplement marketers like those described in the opening post.

    Bookmark   September 10, 2007 at 12:38PM
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