Monday, June 17, 2019
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Many dietary supplements contain unauthorized, hazardous ingredients: Study

(Health Day) -U.S. Health authorities have issued over 700 warnings over the last decade about the sale of supplements containing unauthorized and potentially hazardous drugs, new research shows.

In almost all cases (98 percent), the presence of such components was not found anywhere on the supplemental label, as the U.S. Food and Drug Administration noted.

From 2007 to 2016, the lion's share of FDA warnings – 46 percent – included dietary supplements that sought increased sexual pleasure, while 41 percent of warnings referred to weight loss products. Most of the remaining warnings (12 percent) related to dietary supplements marketed as muscle building products, as the results showed.

The problem of pollution has increased in recent years, 57 percent of all warnings have been spent since 2012, the researchers said.

"In the last ten years since I first saw the problem, I've just seen that the number of drug-adulterated supplements is increasing rapidly," Dr. Pieter Cohen. He is an internist with Cambridge Health Alliance and Associate Professor at Harvard Medical School in Boston.

"In 2009, it appeared that there could be fewer than 150 brands of nutritional supplements that contain drugs," he added. "Now it's clear that there are well over 1,000 brands of nutritional supplements that contain active medications."

Cohen is the author of an editorial accompanying the new analysis, which was published online on October 12th JAMA network open, The study was led by Madhur Kumar, the California Department of Public Health's Food and Drug Branch.

Kumar's team found that more than half of all adult Americans routinely take dietary supplements in the form of nutritional supplements, with annual sales estimated at $ 35 billion.

The FDA expressly warns that supplements are not a substitute for over-the-counter or prescription medications and should not be considered as a way to treat or prevent any disease.

The agency classifies dietary supplements – including vitamins, minerals, botanicals, amino acids and enzymes – in the category of food and not of drugs.

This distinction is important.

"Supplements are handled completely differently than prescription drugs or over-the-counter medications," Cohen said. "These two categories are carefully reviewed by the FDA and supplements are not reviewed by the FDA and do not require the agency to provide any evidence of safety or efficacy before they are sold to consumers."

The 1994 FDA's Health and Education Act essentially sets the burdens of evaluating the safety, content and labeling of nutritional supplements, especially on the shoulders of manufacturers, he said.

Experts point out that this arrangement means that, while the FDA has the power to remove any harm-causing additive from the market, from a practical point of view, it will not do so until after the fact. This increases the risk of a wide range of "serious adverse events" involving infested dietary supplements – including stroke, kidney failure, liver injury, blood clots and even deaths.

The study team estimated that there are approximately 23,000 emergency rooms and 2,000 hospitalizations per year in the United States.

The new analysis reviewed information from a decade contained in an FDA database titled "Dirty Products Being Marketed as a Dietary Supplement".

Nearly 800 corrupt warnings were issued during the review period for supplements manufactured by 147 different companies, though some had multiple warnings about the same supplement, the study authors said.

About 20 percent of the warnings identified products containing more than one unauthorized ingredient, the researchers found. Sildenafil (commonly known as Viagra) was the ingredient in almost half of the warnings regarding sexual enhancement supplements.

Sibutramine, an appetite suppressant that was withdrawn from the market in 2010 due to cardiovascular risks, was cited in nearly 85 percent of weight loss products, according to the report.

Among the muscle-building drugs, synthetic steroids or steroid-like ingredients are a cause for concern in almost 90 percent of the cases, the researchers said.

Cohen said any meaningful solution would require a change in the laws governing the way the FDA monitors supplements. Apart from that, you should "ask your doctor if you need to take supplements," he advised.

"If your doctor does not recommend dietary supplements for your health, they probably will not help you," Cohen said. "However, I advise my patients, who still want to use dietary supplements, to buy supplements that contain only one ingredient on the label, and to avoid any supplements that are healthier on the label, such as improving immunity or strengthening the muscles. "

Explore further:
New study finds simultaneous use of prescription drugs and dietary supplements could pose health risks

More information:
Pieter A. Cohen, M.D., General Internist, Cambridge Health Alliance and Associate Professor, Harvard Medical School, Boston; October 12, 2018, JAMA network open, online

The US Food and Drug Administration has other supplementary regulations.

Journal Reference:
JAMA network open


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