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(Reuters Health) – Potentially dangerous pharmaceuticals not listed on product labels have been found in more than 700 over-the-counter dietary supplements, researchers said.
According to the report published in the JAMA Network Open, pharmaceuticals, found in so-called natural products, were more likely to be included in supplements sold as weight loss aids, muscle inducers, and male libido enhancers.
The study data comes from contaminated food and drug administration products marketed as dietary supplements, the Drug Evaluation Center and the research database. The researchers, led by Madhur Kumar of the California Department of Public Health in Sacramento, identified 776 contaminated supplements in the database, between 2007 and 2016.
To put the problem into perspective, the authors cite a study published in 2015 in the New England Journal of Medicine. This study found that the use of dietary supplements was associated with 23,000 emergency visits and 2,000 hospitalizations each year.
In this study, 45.5% of contaminated products were marketed as aids in sexual reinforcement, 40.9% in weight loss and 11.9% in muscle strengthening. They contained pharmaceuticals such as sildenafil, which is the active ingredient in Viagra; Sibutramine, the active ingredient in Meridia, a slimming drug withdrawn from the market because of its links with a stroke and other cardiovascular events; and anabolic steroids or steroid-like substances.
Dr. Louis Aronne was not at all surprised by the results of the study. "It's something we've seen over and over again," said Aronne, professor of metabolic research and director of the Comprehensive Weight Control Center at Weill Cornell Medicine in New York. "There is no evidence that over-the-counter products work for weight loss and those who do so appear to be at high risk of becoming what the FDA calls" adultery, "Aronne said. "They have prescription drugs in them and that's why they work."
Another danger of these "adulterated" supplements is "they may have a combination of several different agents that act in the same way and that produce a pharmacological effect," said Aronne. Unfortunately, he added, "people want to believe that it works and have no side effects."
Soiled supplements are very difficult to regulate, says Aronne, because they are often sold and marketed on the Internet.
What Californian researchers have reported "is only the tip of the iceberg," Aronne said. A big part of the problem, he said, is that US laws allow a company "to say whatever it wants, and it is up to the FDA and the Federal Trade Commission to stop it from saying so. Canada, the rules are different, Health Canada must approve the claims on the label. "
When it comes to supplements that promise weight loss, muscle gain, or increased libido, "it's the Wild West," said Dr. Lawrence Appel, director of the Welch Center for Prevention, Disease Prevention and Control. Epidemiology and clinical research at Johns Hopkins medical facilities in Baltimore. "There is a huge amount of supplements, really, almost unregulated."
Daniel Manufacturer, CEO / President of the Natural Products Association says that most supplements are at least as safe as FDA-approved drugs. The products mentioned in the new study "are not dietary supplements," said Manufacturer. "These are drugs posing as supplements. We support the continuation of criminal activity, whether it is illegal drugs entering our country or illegal drugs in supplements. "
The safety of supplements is monitored by the same type of adverse event reporting system that tracks drugs after they are approved by the FDA, said Manufacturer, former director of the dietary supplement programs division at the FDA.
The manufacturer has given advice on how to avoid contaminated supplements.
"There are red flags," he said. "If it sounds too good to be true, it's too good to be true. If it promises big gains in weight loss, strength, or if it's comparable to Viagra, it's a red flag. And look for products that have labels in two languages. "
The California Department of Public Health will not make the authors available for comment.
SOURCE: bit.ly/2KVMa1V JAMA Network Open, posted on October 12, 2018.
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