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FDA warns of dangerous dietary supplements
Reumofan Plus and Reumofan Plus Premium are used to treat conditions including arthritis, osteoporosis and muscle pain.
August 22nd, 2012
10:14 AM ET

FDA warns of dangerous dietary supplements

The Food and Drug Administration has received dozens of reports about harmful side effects - including stroke and death - linked to two dietary supplements currently on the market, Reumofan Plus and Reumofan Plus Premium.

The agency has issued a safety alert to warn consumers about the dangers of the supplements. They are both marketed as natural dietary supplements but the FDA claims they have potentially dangerous active ingredients that aren't listed on their labels. The supplements are used to treat arthritis, osteoporosis, muscle pain, bone cancer and a host of other ailments.

They are manufactured in Mexico by Riger Naturals, but sold in the United States in some stores, Internet sites and flea markets. Most are labeled in Spanish but there could be versions with English labels.

The FDA is working closely with the Mexican government and says the Mexican Ministry of Health issued a health warning to the public and ordered Riger Naturals to recall the products.

In June, the FDA issued its first initial warning to consumers about Reumofan Plus based on preliminary laboratory tests. But after receiving increased reports of health problems, confirming drug ingredients and finding similar ingredients in Reumofan Plus Premium, officials decided to issue a second warning.

"Consumers taking these products are urged to immediately consult with their doctor to safely discontinue use of the product," said FDA spokeswoman Sarah Clark-Lynn. "The hidden drug ingredients in Reumofan Plus and Reumofan Plus Premium can lead to serious, even life-threatening health consequences. The longer the product is taken, the higher the risk of these serious health consequences."

The FDA says its lab analysis found prescription drug ingredients including dexamethasone, diclofenac sodium and methocarbamol in the supplements.

Dexamethasone is a corticosteroid used to treat inflammation. It can cause high blood sugar, injury to bone and muscle and psychiatric problems. Taking high doses of the drug or stopping it suddenly can cause low blood pressure and low blood sugar, fever, dizziness, nausea and fatigue.

"Abrupt discontinuation of corticosteroids may cause serious withdrawal syndrome and life-threatening adrenal suppression," Clark-Lynn said. "These risks depend upon a number of variables that need to be assessed by a health care professional, and medical intervention may be necessary. Only a licensed health care professional can evaluate patients for the risk, or confirm the existence, of adrenal suppression."

Diclofenac sodium is an NSAID - a non-steroidal anti-inflammatory drug. Taken improperly, it can increase the risk of gastrointestinal (GI) problems including ulcers, bleeding, fatal rupture of the stomach and intestines and cardiovascular events like heart attack and stroke.

Methocarbamol is a muscle relaxer that can cause sleepiness and dizziness and affect a person's ability to drive a car or operate machinery. Equally concerning, the FDA says, is the fact that these ingredients could interact with other medications and cause serious health problems.

The FDA is asking doctors and consumers to report any side effects related to the two supplements to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.


soundoff (47 Responses)
  1. Portland tony

    Seriously, Stupid is as stupid does....Let the buyer beware! Even the most backwards itinerant aboriginal doesn't swallow stuff they don't recognize. Even with a label on it!

    August 22, 2012 at 11:45 | Report abuse | Reply
  2. BinaryTooth

    Obama needs to step in and regulate this industry!

    Obama 2012

    August 22, 2012 at 12:53 | Report abuse | Reply
    • ROMNEY 2012

      Obama will be defeated in November – because all medical marijuana patients in America have been betrayed.

      Libertarians ARE the swing vote in 2012 and we will vote for Romney because Obama has broken his promise to the 37 million registered patients in the 16 states that have legalized its use...!

      August 22, 2012 at 18:05 | Report abuse |
    • Wayne A.

      Let's keep Obama and company out of it. Buy only from reputable sources.

      August 23, 2012 at 22:16 | Report abuse |
  3. thedoctor

    The dietary supplements industry is one of the biggest scams ever pulled on the American public. If it's a drug, it has to be proven "effective" by the FDA. But if it's a "dietary supplement," they can sell any old crap as long the body count doesn't get too high.

    August 22, 2012 at 13:04 | Report abuse | Reply
    • JM

      You can thank Orin Hatch the (R) from Utah. He successfully got Anabolic Steriods added to the felony banned substances and deregulated teh "diet supplement" industry at the same time. Utah is the home of about 25% of the total manufacturers of supplements (at least in '91) so it was big business in Utah and doing things like test your products for safety and actually prove your claims would slow down the money machine. That is why he spearheaded that initiative. When the FDA could no longer regulate them they were allowed to put in whatever they wanted and make unsubstantiated claims as they saw fit. it was all for profit for his state.

      August 22, 2012 at 13:50 | Report abuse |
  4. joe schmoe

    And the herd thins out a little more yay!

    August 22, 2012 at 13:20 | Report abuse | Reply
    • New Gawker

      how appropriate to use herd hahahaha.

      August 22, 2012 at 13:22 | Report abuse |
  5. New Gawker

    Whoa whoa whoa!!! You mean those pills they push promising miracles are bad for you and may kill you??!!!!

    August 22, 2012 at 13:22 | Report abuse | Reply
  6. billie bob johnson strat

    Diet and aids may kill? Remind me not to diet or get the aids.

    August 22, 2012 at 13:28 | Report abuse | Reply
  7. ted

    but... but... but...
    I thought we all had to be skinny or everyone will get diabetes and DIE.
    Diet pills, that every one created TO DATE has caused liver, and heart disease.
    Bariatric surgery can lead to digestive problems later in life, where your whole esophagus and most of your stomach has to be taken out and rerouted straight to your large intestine.
    Most fat people are fat because of hormonal or thyroid problems.

    But because god forbid there's a few teens playing Video games, then everyone is fat, and they are fat because they don't exercise.

    More over the sheer audacity of the lie and over exaggeration of the amount of obese people, they do it with a straight face, so Nancy Pelosi can convince people to pass legislation that no one even reads.

    Can't we just throw fat repulsive people off the plane that cramps some hip Liberals style by sitting next to him. With out politicizing the issue. I mean sorry to Bill Mahar out.

    August 22, 2012 at 13:42 | Report abuse | Reply
    • dewshbag

      Bill Maher, whether you agree with him or not, has a point...you're nothing like him.

      August 22, 2012 at 13:48 | Report abuse |
    • deadlyserious

      "Most people are fat because of hormonal or thyroid problems."

      And you have evidence to back that up, right?

      August 22, 2012 at 14:32 | Report abuse |
  8. Davehuckle

    Having been on numerous diets in my time i can honestly say that your own willpower is the ultimate key to losing weight & also keeping this lost weight off. Supplements designed to make you lose weight most often do not work and some are extremely dangerous. You should never try to lose more than 2 to 3 pounds per week and 50% of this weight loss should come from diet while the other 50% should come from exercise.

    August 22, 2012 at 13:50 | Report abuse | Reply
    • Eric

      Maybe if you're 25..... Otherwise it's four parts diet and one part exercise. Change your lifestyle, write down everything you eat and drink, and you'll lose all your excess weight in six months to year. It's that easy, and that hard.

      August 22, 2012 at 14:50 | Report abuse |
  9. Davehuckle

    I forgot to say that my neighbor just lost 150 lbs. Would you like to know how he did it? He told me that he is afraid of needles if he was to become that type of diabetic. Wow!! He looks unreal now. From 380 lbs. all of the way down to 230 lbs. and he wants to lose more.

    August 22, 2012 at 13:52 | Report abuse | Reply
  10. Derek Clontz

    Bad headline, inaccurate and misleading, perhaps disingenous, perhaps ugly propaganda. These are NOT dangerous dietary supplements these criminals are peddling. They are dangerous pharmaceutical drugs IMPROPERLY labeled as dietary supplements. Editors: If you don't see the distinction, you are in the wrong business, and, of course, incompetent. Dr. Sanjay Gupta – by allowing misleading and erroneous headlines like this to appear in a news venue that you endorse, you expose yourself as careless, reckless, incompetent, or, as some might argue, a charlatan with an agenda.

    August 22, 2012 at 14:29 | Report abuse | Reply
    • Cynthia

      The have the legal right, thanks to GOP, to label them as supplements. They aren't improperly labeled per the law. Your point is only partially factual. The headline is correct in the classification of these products. That is the whole point! They may label and sell them as supplements, but they will often have dangerous properties. sheesh

      August 22, 2012 at 15:00 | Report abuse |
  11. Jessica

    It is always a shame to see one dietary supplement have a contaminant because the general public then assumes that all dietary supplements are dangerous or ineffective. In fact, any supplements have shown great benefit for certain conditions. The Natural Standard is a great database to look up which alternative treatments have been shown to actually work. They also provide information on standardization of ingredients and products that have been studied.

    August 23, 2012 at 13:35 | Report abuse | Reply
    • coldrealitynews

      Go to http://www.nomorefakenews.com and read Jon Rappoports Articles. The FDA and Big Pharma are hurting us bad and our troops.

      August 23, 2012 at 15:24 | Report abuse |
    • Wayne A.

      Very well said, Jessica. Big Pharma is the enemy.

      August 23, 2012 at 22:20 | Report abuse |
  12. coldrealitynews

    The FDA in their own docs and website have admitted the drugs and procedures they approve kill 270,000 people every year. They are not a source to listen to about anything as they are in bed with the drug cartel that basically kills us. They are demonizing supplements because people are waking up to the medical dictatorship in the USA and they know this. Stop the FEAR and DEATH ADMIN from killing more of the human family.

    August 23, 2012 at 15:20 | Report abuse | Reply
  13. coldrealitynews

    END THE FDA NOW.

    August 23, 2012 at 15:21 | Report abuse | Reply
  14. Kate

    Well the thing is nobody should be taking supplements or any meds without consulting a Doctor. I usually buy my meds locally and only after being diagnosed and prescribed by my doctor. But no local store can compete with online prices so I sometimes buy my meds online. I've tried many online pharmacies with many disappointments in the process. A few month back I found http://www.pilltablets.com and they've been an excellent online pharmacy store with really great customer service and to top it off it support COD shipping so you can verify your meds before paying.....

    August 24, 2012 at 14:08 | Report abuse | Reply
  15. Davehuckle

    My neighbor told me that he has lost 150 lbs. on his diet. I asked him what his motivation was? He said he is afraid of needles as he is diabetic and if his disease got worse he would have to give himself insulin injections.

    August 24, 2012 at 16:44 | Report abuse | Reply
  16. RG

    Scary! It is unfortunate that mishaps like this occur. I am really glad this was found by the FDA, otherwise many people would have been effected by this. Natural Standard's an authority on integrative medicine also posted this blog on their website. It nice to know that websites such as CNN and Natural Standard are proactive in posting news like this, so people of the general public are aware.

    Note: These postings are my own and do not necessarily represent Natural Standard’s positions, strategies or opinions

    August 31, 2012 at 15:25 | Report abuse | Reply
  17. whiki

    it is true!
    The FDA in their own docs and website have admitted the drugs and procedures they approve kill 270,000 people every year. They are not a source to listen to about anything as they are in bed with the drug cartel that basically kills us. They are demonizing supplements because people are waking up to the medical dictatorship in the USA and they know this. Stop the FEAR and DEATH ADMIN from killing more of the human family.

    September 12, 2012 at 18:25 | Report abuse | Reply
  18. Protein King

    I agree, the FDA is a good idea but in practice it doesn't work too well... In Australia, we pretty much follow the US' lead on banning products, but I think our enforcement is much stricter. More discussion here

    September 19, 2012 at 19:00 | Report abuse | Reply
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    October 7, 2012 at 11:21 | Report abuse | Reply
  20. suvs76

    For many health benefits, try to the world's most potent Fresh Royal Jelly by Well Bee-ing UK. Go to http://www.wellbee-ing.com or http://www.royaljellyinhoney.co.uk.

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  21. beccadog10

    The U.S. FDA warns about secret ingredient in food supplements that are not on the label. Is this not the reason why food and supplement labels should contain wording that these products may contain genetically modified organisms?
    When L-Tryptophan made by Showa Denko during the late 1980's or early 1990's entered the USA, it killed 37 and permanently disabled 1,500 people in the United States in a disease called eosonophil myalgia syndrome (EMS). The reason we later learned was because this product contained a genetically modified organism. Not all the L-Tryptophan on the health food store shelves was contaminated. The bottles I had purchased were not and I've never had a problem with the non-GMO L-Tryptophan.

    Having mandatory labeling would give consumers enough information for personal responsibility and physicians information to persuade consumers to avoid certain products.

    Now, I'm finding the biotechnology firms have submitted widely used herbal food supplements to be among the preliminary list of agents to be reviewed for their carcinogenic risks to humans in Lyon, France, June 2012 to the International Agency for the Research on Cancer. At the top of the list is Aloe Vera, Goldenseal root powder, and Ginkgo biloba extract (90045-36-6). http://monographs.iarc.fr/ENG/Meetings/vol108-listagents.pdf Will these be amongst the next food supplements to be genetically engineered, like L-Tryptophan?

    Mandatory labeling and the right to know could solve many potential problems and allow consumers to be partner's in the protection of health.

    October 24, 2012 at 22:37 | Report abuse | Reply
  22. Siemens

    I agree, the FDA is a good idea but we use any diet supplements with doctors advice no harmful effect to us

    November 23, 2012 at 01:18 | Report abuse | Reply
  23. Jamie Bruck

    Most diet pills are dodgy and can play havoc with your health. My wife told me she was going to purchase some and at first I was not happy. But in the end I thought – better to help her get something that was safe. we spent hours searching on line and plumped for one from the UK that was basically saying the same thing BE CAREFUL WHEN CHOOSING DIET PILLS. What they said made sense so we purchased them (innov-eat). They say they are proven by science and whilst I think there is a placebo effect she has lost a couple of pounds each week being on these.

    November 28, 2012 at 08:53 | Report abuse | Reply
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  28. ruthmiller008

    Without getting doctor’s prescription nobody should take any supplements or medicine. Again with anything excess can cause problem but here it seems like problem is in root.

    February 6, 2013 at 04:02 | Report abuse | Reply
  29. dave pickwick

    I have taken this suppliment and it did wonders for my joints. Now if you listen to every commercial about any drug you get a list of side effects that would make you say why would I take that it will kill me before the aliment your taking it for. None of the drugs that are listed in the artical were list on the bottle, Honestly I would keep taking them if availible. To me the pain free feeling is worth the risk. No different than taking any other wonder drug that may cause Heart attacks, diarria , nausia, bleeding, ulcers, vomiting, dizzyness, strokes, erectile dysfunction, and Death. When you have constant pain you can understand why we would take the risk. It made friends and family feel Great and pain free.

    February 6, 2013 at 11:57 | Report abuse | Reply
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