FDA Warns Amazon and Walmart About Selling Misbranded Drugs

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has issued another warning to consumers not to purchase or use dietary supplements marketed for pain relief under the brand names “Artri” or “Ortiga” due to potentially dangerous pharmaceutical ingredients. Use of the products has led to liver toxicity and at least one death, according to the agency.

The FDA issued its first first warning about the supplements in January and followed up with a second warning  in April. The latest warning includes Amazon, Walmart and another retailer that continued to sell the supplements, which are marketed with claims that they treat arthritis and osteoarthritis, restore cartilage, and stop joint deterioration.

In a warning letter sent to Amazon last week, the FDA said it had purchased Artri and Ortiga supplements through its website and had them delivered through the company’s delivery service.

Laboratory testing confirmed the supplements purchased through Amazon contained diclofenac, a non-steroidal anti-inflammatory drug (NSAID), and dexamethasone, a corticosteroid used to treat inflammatory conditions.

Neither drug is mentioned on product labels, which list ingredients such as glucosamine and turmeric. The FDA warned Amazon that introducing or delivering a misbranded drug is a violation of federal law.  

“Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction. Please submit a written response to this letter within fifteen working days from the date of receipt, explaining the specific steps you have taken to address any violations,” the FDA letter states.

Similar warning letters were sent to Walmart and Latin Foods Market, which had previously issued voluntary recalls for the supplements, but still continued to sell them.

It appears the Artri and Ortiga supplements have now been removed from the websites of all three companies. The supplements were being marketed primarily to Spanish-speaking consumers, with claims they are “highly effective in restoring cartilage” and “fights arthritis.”  

Diclofenac raises the risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal bleeding and damage. When used long term or in high doses, dexamethasone and other corticosteroids can result in serious withdrawal symptoms if a consumer suddenly stops taking them. Both drugs can also interact with other medications.

The FDA encourages healthcare providers and patients to report side effects involving use of the products to its Adverse Event Reporting System. .

FDA Warns Supplements for Pain Contain Undeclared Drugs

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is warning consumers not to purchase or use dietary supplements marketed for pain relief under the brand names “Artri King” or “Ortiga” due to potentially dangerous ingredients not listed on their labels. Use of the products has led to at least one death, according to the FDA.

The Artri King and Ortiga supplements are promoted as treatments for arthritis, muscle aches, osteoporosis, bone cancer and other painful conditions – and list ingredients such as glucosamine, turmeric and Omega 3. But FDA laboratory analyses found the supplements also contain undeclared drugs such as steroids, muscle relaxants and non-steroidal anti-inflammatory drugs (NSAIDs):

• Dexamethasone (a corticosteroid) is commonly used to treat inflammatory conditions. It can impair a person’s ability to fight an infection and at high doses can cause increased blood glucose levels, changes in blood pressure, damage to bones, psychiatric problems and adrenal dysfunction.

• Diclofenac sodium (a NSAID) can raise the risk of cardiovascular problems, such as heart attack and stroke; serious gastrointestinal damage, including bleeding, ulcers, and fatal tears of the stomach and intestines; and liver toxicity that can result in death or the need for a liver transplant.

• Methocarbamol (a muscle relaxant) can cause sedation, dizziness and low blood pressure.

Artri King advertisement

The FDA urges consumers taking the supplements to immediately talk to a healthcare provider about safely discontinuing their use because suddenly stopping the undeclared drugs may be dangerous. The drugs may also interact with other medications a person is taking.

The FDA said it has received reports of adverse events, including liver toxicity and death, associated with the use of Artri Ajo King supplements since the agency issued its first warning on January 5, 2022. A second warning about Artri King was issued this week.

The FDA’s new warnings include Ortiga Mas Ajo Rey and Ortiga Mas Ajo Rey Extra Forte supplements, which are promoted as treatments for joint pain and arthritis.

Artri King and Ortiga sold their products on various websites, including Amazon, Walmart and E-Bay, as well as some retail stores, primarily targeting Spanish-speaking consumers.

Acetaminophen Warning Labels Ineffective

Sometimes warnings from government health agencies don’t have their intended impact. Such is the case for warnings from Health Canada about taking high doses of acetaminophen, a pain reliever widely used in over-the-counter medicines for headache, cough, cold and flu.

Product labels for acetaminophen were changed in Canada in 2009 to warn of the risk of possible liver damage. In 2016, the labeling was updated with additional information about safe dosing and to identify products containing acetaminophen.

But those changes did not decrease rates of hospitalization for acetaminophen overdoses, according to a new study published in CMAJ (Canadian Medical Association Journal).  In an analysis of more than 12 000 hospital admissions for acetaminophen overdoses in Canada between 2004 and 2020, researchers found the updated warning labels had little impact.

"We found that changes to acetaminophen labels that communicated the risks of overdose and the presence of acetaminophen in over-the-counter products did not affect rates of hospital admission for accidental acetaminophen overdose, ICU admission for accidental acetaminophen overdose and admission for acetaminophen overdoses involving opioids," writes lead author Dr. Tony Antoniou, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Unity Health Toronto.

Previous research has found that less than half of patients regularly read labels for over-the counter analgesics, and only 26% read the active ingredients before using them the first time. Acetaminophen is used in so many different products that consumers may be unaware how much they’re taking. As a result, up to 6% of patients exceed the maximum daily recommended dose.

The FDA warned U.S. consumers about the risk of acetaminophen causing liver injury in 2009. Five years later, the agency told manufacturers to stop selling drug products with more than 325 milligrams of acetaminophen per dose.

Those actions have done little to prevent adverse reactions to acetaminophen. According to the FDA’s Adverse Events Reporting System, nearly 2,800 adverse events involving acetaminophen were reported in 2009. By 2021, the number of adverse events had grown to over 15,000, a 440% increase. Over 27,000 drug deaths involving acetaminophen were reported from 2009 to 2021.