FDA Warns Amazon of Joint Pain Supplements That Contain Ingredients Linked to Heart Attacks and Internal Bleeding
- The FDA has warned Amazon about the sale of three supplements:
- The pills are intended to relieve arthritis, joint pain, migraines and more
- FDA found they contain the NSAID diclofenac, which is linked to heart problems
- All the way back in June, traces of the drug were found in the supplements
Artri King Reforzado con Ortiga y Omega 3 costs about $25 a bottle at online retailers
The Food and Drug Administration (FDA) has warned online retail giant Amazon about selling potentially dangerous supplements.
Three products sold to treat joint pain and marketed to the Latino community were found to contain undeclared active ingredients that can cause serious heart problems.
The supplements – ‘Artri Ajo King’, ‘Ortiga Mas Ajo Rey’ and ‘Artri King Reforzado con Ortiga y Omega 3’ – contain the non-steroidal anti-inflammatory drug (NSAID) diclofenac.
The FDA warns that the ingredient may put users at risk of heart attack, stroke, internal bleeding, stomach problems and perforation of the stomach and intestines.
In January, the products were first discovered to contain the NSAID, with the FDA warning consumers to avoid the products.
On October 28, the agency issued a letter to Amazon CEO Andy Jassy warning the company’s online marketplace to remove them from the online marketplace.
It is the second time in recent months that Amazon has been furious with regulators. In August, it was warned about the sale of unapproved skin products.
Both Artri Ajo King and Ortiga Mas Ajo Rey retail for around $20 a bottle
NSAIDs – a crucial tool for combating aches and pains that come with some drawbacks
Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used to treat back pain, arthritis, and other problems.
They include common over-the-counter medications such as aspirin, Advil, and Aleve.
They work by blocking chemicals in the body that cause inflammation and pain through slow tissue damage, reducing arthritis symptoms.
NSAIDs are also effective against symptoms caused by fever, although their use is not recommended for more than three days.
They work quickly and in some cases work within hours.
However, these drugs come with some risks, including an increased risk of heart attack or stroke for repeat users.
They should not be used alongside blood thinners or other medications that affect the heart or blood flow.
Source: Cleveland Clinic
“As discussed below, your company is responsible for introducing, supplying or causing the introduction or delivery into interstate commerce of these products, which are unapproved new drugs,” the letter reads.
“…the introduction or supply of these products for introduction into interstate commerce is prohibited.”
Artri Ajo King and Ortiga Mas Ajo Rey retail for about $20 a bottle. Artri King Reforzado con Ortiga y Omega 3 costs $25 for the standard bottle.
The FDA has approved diclofenac as a drug to treat arthritis, migraines, and other body aches.
The arthritis drug Voltaren, manufactured by pharma giant GlaxoSmithKline, is the most common branded version.
It is strictly controlled and its use in the US is heavily regulated due to its potential hazards.
“NSAIDs can cause an increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration and fatal perforation of the stomach and intestines,” the FDA writes.
‘The undeclared diclofenac ingredient in? [the three products] can also interact with other medications and significantly increase the risk of side effects, especially when consumers use multiple NSAID-containing products.”
The FDA first became aware of the NSAID’s presence in the supplements after it conducted lab tests in January.
It notes that the sample tested was purchased directly from Amazon.
In June, Latin Foods Market — which manufactures the products — issued a nationwide recall of some batches of the drug.
However, products remained in some markets and Amazon allowed their sales to continue, violating FDA rules.
“You are responsible for investigating and determining the causes of any violations and for preventing the recurrence or occurrence of other violations,” the FDA warned Mr. Jassy.
“It is your responsibility to ensure that your business complies with all requirements of federal law, including FDA regulations.”