That Health Rules

Supplements are always promoted as healthy alternatives to the usual medications doctors prescribe.  The marketeers are always advertising the products as devoid of any side effects because they come from “natural sources” of which the labeling may not actually tell us what they are and where they come from.  But almost always our patients are “tricked” into buying them because of the ads on TV or radio based on testimonials that they can cure a variety of ailments or based on the “convincing” strategy of the expert sellers. 

The US FDA and local BFAD have been very lenient with this multi-billion dollar industry in terms of limiting their exposure to the public lest their products can harm.  Instead you see them proliferating with seals of aproval from these agencies as” approved by BFAD”.  Although there is always a label ” No Therapeutic Claim” but who reads them when all the patients hear are the blubbering testimonials and ads on TV and radios….

One recent example of what can happen if these products go undetected is the recent warning of a supplement which actually contained an Anticholesterol agent.  Although the product is approved for use as a drug…but if it is present in a supplement, the patients taking them may not mind checking for possible side effects trusting the sellers of the product as side effect free!

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FDA Warns Consumers to Avoid Red Yeast Rice Products Promoted on Internet as Treatments for High Cholesterol

The U.S. Food and Drug Administration is warning consumers not to buy or eat three red yeast rice products promoted and sold on Web sites. The products may contain an unauthorized drug that could be harmful to health. The products are promoted as dietary supplements for treating high cholesterol.

The potentially harmful products are: Red Yeast Rice and Red Yeast Rice/Policosonal Complex, sold by Swanson Healthcare Products, Inc. and manufactured by Nature’s Value Inc. and Kabco Inc., respectively; and Cholestrix, sold by Sunburst Biorganics. FDA testing revealed the products contain lovastatin, the active pharmaceutical ingredient in Mevacor, a prescription drug approved for marketing in the United States as a treatment for high cholesterol.

“This risk is even more serious because consumers may not know the side effects associated with lovastatin and the fact that it can adversely interact with other medications,” said Steven Galson, M.D., M.P.H., director of FDA’s Center for Drug Evaluation and Research.

These red yeast rice products are a threat to health because the possibility exists that lovastatin can cause severe muscle problems leading to kidney impairment. This risk is greater in patients who take higher doses of lovastatin or who take lovastatin and other medicines that increase the risk of muscle adverse reactions. These medicines include the antidepressant nefazodone, certain antibiotics, drugs used to treat fungal infections and HIV infections, and other cholesterol-lowering medications.

FDA has issued warning letters advising Swanson and Sunburst Biorganics to stop promoting and selling the products. Companies that do not resolve violations in FDA warning letters risk enforcement actions, such as an injunction against continuing violations and a seizure of illegal products.

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There you go… this is only one of the many that we see patients getting complications either of the liver or the kidney arising from taking supplements. As physicians we can not go after anybody since the supplemetns are bought by patients at their own free will. 

The local BFAD however should be more careful in approving supplements and should have more teeth to penalize companies that promote these products as drugs which are now being done extensively.  Just watch your cable TV and you’ll be bombarded by ads on the numerous illnesses that these supplements can heal!

Be Smart…Know The Real From The Fake!

Read My Other Related Articles:

1. The FDA Rules On Dietary Supplements
2. Beware of the Weight Loss Myth
3. What You Need To Know About Dietary Supplements
4. The Harmless Herbs?