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FDA identifies 2 red-flag words to look out for on your supplement labels — it's a sign they contain hidden ingredients linked to heart attacks and stomach ulcers

Apr 26, 2022, 03:24 IST
Insider
Scientists and medical experts have called for greater FDA oversight into over-the-counter dietary supplements.Getty
  • The FDA warned consumers against supplement sellers with variations of the name "Artri" and "Ortiga."
  • These Mexico-based sellers contain dangerous, unlisted ingredients that can cause ulcers and high blood pressure.
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The US Food and Drug Administration is cracking down on supplements sold by two Mexico-based vendors.

The FDA released a consumer warning on April 20 that said supplements with variations of the name "Artri" or "Ortiga" contain dangerous hidden active ingredients not listed on the product label.

The supplements are marketed as treatments for symptoms of arthritis, muscle pain, osteoporosis, and bone cancer, per the FDA.

The agency's laboratory analyses revealed certain Artri and Ortiga products contain, but do not list, potentially dangerous ingredients including:

  • Declofenac. An FDA laboratory analysis from January found Artri Ajo King contains declofenac as an unlisted ingredient. A non-steroidal anti-inflammatory drug (NSAID) similar to ibuprofen and aspirin, it can lead to serious gastrointestinal problems, like ulceration and perforation, if taken incorrectly.
  • Diclofenac sodium. The FDA found Ortiga products also typically contain diclofenac, which can increase the risk of cardiovascular events like stroke and heart attack, and may lead to ulceration or fatal perforation of the stomach and intestines.
  • Dexamethasone, a corticosteroid that has been used to treat severely ill COVID-19 patients on ventilators. It can change blood pressure, cause infections, and damage bones.
  • Methocarbamol, a muscle relaxant used to treat pain or injury that can cause sedation and dizziness.

Both Artri and Ortiga are manufactured in Mexico and are labeled primarily in Spanish, per the FDA and eBay.

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The supplement industry is barely regulated

Supplement sales have skyrocketed since 2020, part of the wellness industry's continued growth. Scientists and medical experts have called for greater FDA oversight into over-the-counter dietary supplements, as the agency does not approve pills prior to sale the way it regulates prescription medicine.

Harvard Medical School and independent product testing company NSF International identified four unapproved, unlisted stimulants in six supplements marketed for weight loss and fitness in 2017.

A 2017 study in the Journal of Clinical Sleep Medicine found the amount of melatonin in 71% of supplements is off by a 10-percent margin, meaning the majority of sellers mislabel how much of the hormone is in the pill. The study also found the amount of melatonin within pills in a single jar can vary by a whopping 465%.

US poison control centers have received 275,000 reports of people who reacted badly to supplements over the past two decades, Insider's Erin Brodwin previously reported.

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