Hundreds of dietary supplements shown to contain unapproved drugs
17 Octobre, 2018, 13:10 | Auteur: Yves Courtet
Yet over the last decade, more than 750 supplement brands have been found to be tainted with drugs - sometimes containing two or more hidden drug ingredients, a new study finds. Most of these products were marketed for sexual enhancement (353 [45.5%]), weight loss (317 [40.9%]), or muscle building (92 [11.9%]), with 157 adulterated products (20.2%) containing more than 1 unapproved ingredient.
Researchers found that almost 800 dietary supplements being consumed by Americans are actually tainted with one or more drugs.
With an estimated 50 percent of Americans consuming some type of supplement, researchers note that the $35 billion industry is a big business.
Design, Setting, and Participants In this quality improvement study, data were extracted from the FDA's Center for Drug Evaluation and Research, Tainted Products Marketed as Dietary Supplements_CDER database from 2007 through 2016. The database is maintained on the agency's website as a resource for consumers and to increase transparency and public knowledge. The researchers performed the new analysis independent of the FDA. Otherwise, 443 of the total 776 products were reported from 2012 to 2016. Most of the adulterated supplements were marketed for sexual enhancement, weight loss or muscle building. Drugs found in sexual enhancement products included sildenafil, tadalafil and vardenafil, all active ingredients in prescription medications intended for erectile dysfunction, which, when overused, can cause serious damage to the blood vessels. The appetite suppressant, previously sold as Meridia, has been pulled from the market in the U.S. over concerns about an increased risk for cardiovascular events.
Nearly all the muscle building supplements, 82 out of 92 products, contained synthetic steroids or steroid-like ingredients, which, when abused, can lead to mental health problems, kidney and heart problems, and liver damage. Of the 14 supplements that were promoted as treatments for arthritis, muscle and joint pain, osteoporosis or other painful conditions, half contained diclofenac, a nonsteroidal anti-inflammatory drug (NSAID) and five contained dexamethasone, a steroid used to treat inflammation.
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The FDA's Dietary Supplement Health and Education Act of 1994 essentially places the burden for evaluating supplement safety, content and labeling primarily on the shoulders of the manufacturers.
To get tainted supplements off the market, the FDA first has to try to get the companies to issue a voluntary recall every time the agency finds evidence of drugs in a supplement, Cohen said. Another would give the FDA tougher enforcement tools so that a product's registration could be withdrawn if found to be adulterated. According to data, the FDA sent warnings to the companies, with 28 products being named twice or thrice as adulterated products. The authors wrote that the substances represent "a serious public health concern".
Dietary supplements promising enhanced sexual pleasure, weight loss, and muscle gain secretly contain unsafe pharmaceuticals, researchers warn.
"Only 360 of 746 (48 per cent) were recalled, leaving the majority of adulterated supplements, more than 350 products, available for sale", Cohen said.
"The FDA didn't even bother to recall more than half of the potentially hazardous supplements", writes Dr. Pieter Cohen, a Harvard Medical School professor and an internist with Cambridge Health Alliance in Boston, in an accompanying editorial comment to the paper.
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