[ad_1]
(HealthDay) -U.S. Health officials have issued more than 700 warnings over the last decade about the sale of food supplements containing unapproved and potentially dangerous drug ingredients, according to 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.
Between 2007 and 2016, the lion's share of the FDA's warnings – 46% – involved supplements touting increased sexual pleasure, while weight loss products were cited in 41% of warnings. The results showed that most of the remaining warnings (12%) involved supplements marketed as muscle builders.
The problem of the tainted supplement 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, plant substances, amino acids and enzymes – into 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 requires manufacturers to evaluate the safety, content and labeling of supplements, he said. .
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 of a wide range of "serious adverse events" involving contaminated supplements, such as strokes, kidney failure, liver damage, blood clots and even death, critics of the agreement.
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.
Investigators found that about 20% of the warnings indicated products containing more than one unapproved ingredient. Sildenafil (commonly known as Viagra) was the ingredient in almost half of the warnings about sexual enhancement supplements.
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. "
Explore further:
New study reveals that simultaneous use of prescription drugs and dietary supplements could pose health risks
More information:
Pieter A. Cohen, MD, internist general of the Cambridge Health Alliance and associate professor at Harvard Medical School, Boston; October 12, 2018, JAMA Network open nowonline
The US Food and Drug Administration contains more information on supplements.
Source link
