FDA Warns Amazon of Joint Pain Supplements Containing Ingredients Linked to Heart Attacks and Internal Bleeding
- The FDA has warned Amazon about its sale of three supplements
- The pills claim to relieve arthritis, joint pain, migraines and more.
- The FDA discovered that they contain the NSAID diclofenac, which is linked to heart problems
- Traces of the drug were found in the supplements in June.
Artri King Fortified with Nettle and Omega 3 is around $25 per bottle at online retailers
The Food and Drug Administration (FDA) has issued a warning to online retail giant Amazon for selling potentially dangerous supplements.
Three products sold to treat joint pain and marketed to the Latino community were found to have undeclared active ingredients that can cause serious heart problems.
The supplements, ‘Artri Ajo King’, ‘Ortiga Mas Ajo Rey’ and ‘Artri King Reinforced with Nettle and Omega 3’, contain the non-steroidal anti-inflammatory drug (NSAID) diclofenac.
The FDA warns that the ingredient can put users at risk of heart attack, stroke, internal bleeding, stomach problems, and perforation of the stomach and intestines.
The products were first found to contain NSAIDs in January, and the FDA issued a warning to consumers to avoid the products.
On October 28, the agency published 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 drawn the ire of regulators. In August, he was warned for selling unapproved skin products.
Both Artri Ajo King and Ortiga Mas Ajo Rey retail for around $20 per bottle.
“As discussed below, your company is responsible for introducing, delivering, or causing the introduction or delivery into interstate commerce of these products, which are unapproved new drugs,” the letter says.
‘…it is prohibited to introduce or deliver these products for introduction into interstate commerce.’
Artri Ajo King and Ortiga Mas Ajo Rey retail for about $20 a bottle each. Artri King Fortified with Nettle and Omega 3 is $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, made by pharmaceutical giant GlaxoSmithKline, is the most common brand-name version.
It is strictly controlled and its use in the US is highly regulated due to its potential dangers.
“NSAIDs may cause an increased risk of cardiovascular events, such as heart attacks and strokes, as well as serious gastrointestinal harm, including bleeding, ulceration, and fatal perforation of the stomach and intestines,” the FDA writes.
‘The ingredient diclofenac not declared in [the three products] it can also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.’
The FDA first became aware of the NSAID’s presence in supplements after conducting laboratory tests in January.
He points out that the sample he tested was purchased directly from Amazon.
In June, Latin Foods Market, which makes the products, issued a nationwide recall on some lots of the drug.
However, the products remained in some markets and Amazon allowed their sale to continue, breaking FDA rules.
“You are responsible for investigating and determining the causes of any violations and preventing their recurrence or the 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.’
