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US health authorities have issued more than 700 warnings over the last decade about the sale of food supplements that contain unapproved and potentially dangerous drug ingredients, says a new study.
In almost all cases (98%), the presence of such ingredients has not been mentioned anywhere on the label of supplements, the US Food and Drug Administration found.
From 2007 to 2016, the lion's share of the FDA's warnings – 46% – involved supplements touting increased sexual pleasure, while slimming products were cited in 41% of the warnings. The results showed that most of the remaining warnings (12%) involved supplements marketed as muscle builders.
the stained supplement problem seems to have grown in recent years, with 57% of all warnings issued since 2012, the researchers said.
"In the last ten years, since I started following the problem for the first time, I have only seen the number of adulterated supplements with drugs increase rapidly," said Dr. Pieter Cohen. He is a general internist at the Cambridge Health Alliance and an associate professor at Harvard Medical School in Boston.
"In 2009, it appeared that there could be fewer than 150 brands of supplements containing drugs," he added. "Now, it is clear that there are more than 1,000 brands of supplements containing active drugs."
Cohen is the author of an editorial that accompanies the new analysis, which was published online Oct. 12 JAMA Network open now. The study was led by Madhur Kumar, from the Food and Drug Branch of the California Department of Public Health.
The Kumar team noted that more than half of adult Americans regularly took a form of dietary supplement, their annual business figure being estimated at $ 35 billion.
The FDA explicitly warns that supplements are no substitute for over-the-counter or prescription medications, and should not be considered a way to treat or prevent an illness.
The agency classifies dietary supplements – including vitamins, minerals, plants, amino acids and enzymes – in the category of foods, rather than drugs.
This distinction is important.
"Supplements are treated completely differently than prescription drugs or over-the-counter medications," Cohen explained. "Both of these categories are carefully controlled by the FDA.The supplements are not validated by the FDA and require no evidence of safety or effectiveness to be presented to the agency before being sold to consumers. "
The FDA's 1994 law on dietary supplements, health and education essentially imposes responsibility for assessing the safety, content and labeling of supplements to manufacturers.
Experts point out that this arrangement means that while the FDA has the power to remove any supplement reported as causing injury, it does so only after the fact. This increases the risk for a wide range of "serious adverse events" involving contaminated supplements – including stroke, renal failure, liver damage, blood clots and even death – support the detractors of the scheme.
The study team stated that previous estimates suggest that such events result in approximately 23,000 emergency department visits and 2,000 US hospitalizations each year.
The new analysis reviewed a hundred or so pieces of information contained in an FDA database entitled "Contaminated Products Marketed as Dietary Supplements".
Nearly 800 tainted warnings were issued during the reporting period for supplements manufactured by 147 different companies, although some involve several warnings regarding the same supplement, said the study's authors.
About 20% of warnings identified products containing more than one unapproved ingredient, the investigators found. sildenafil (better known as Viagra) was the ingredient of almost half of the warnings regarding supplements for sexual performance enhancement.
Sibutramine – an appetite suppressant withdrawn from the market in 2010 due to cardiovascular risks – has been cited in almost 85% of weight loss supplements, according to the report.
And among muscle building supplements, synthetic steroids or steroid-like ingredients have raised concerns in up to 90 percent of cases, the researchers said.
Cohen said any significant solution would require a change in the laws that govern how the FDA monitors supplements. Unless, you should "ask your doctor if you need to take supplements," he advised.
"If your doctor does not recommend supplements for your health, it probably will not help you," said Cohen. "However, for my patients who still want to use supplements, I advise them to buy supplements that mention only one ingredient on the label and to avoid any supplement bearing a health claim. on the label, such as improving immunity or strengthening muscles. "
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