FDA issues warning to Amazon over sale of supplements that contain drug linked to heart attacks

Artri King Reforzado con Ortiga y Omega 3 costs around $25 per bottle on 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 towards the Latino community were found to have undeclared active ingredients that can cause severe heart issues.

The supplements — ‘Artri Ajo King,’ ‘Ortiga Mas Ajo Rey,’ and ‘Artri King Reforzado con Ortiga y Omega 3’ — contain the nonsteroidal anti-inflammatory drug (NSAID) diclofenac.

The FDA warns the ingredient can put users at risk of heart attack, stroke, internal bleeding, stomach issues and perforation of the stomach and intestines.

It was first discovered that the products contained the NSAID in January, with the FDA issuing 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 Amazon has drawn regulators’ ire. In August, it 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 firm is responsible for introducing, delivering, or causing the introduction or delivery into interstate commerce of these products, which are unapproved new drugs,’ the letter reads.

‘…introducing or delivering these products for introduction into interstate commerce is prohibited.’

Artri Ajo King and Ortiga Mas Ajo Rey retail for around $20 a bottle each. 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 pains.

The arthritis drug Voltaren, manufactured by pharma giant GlaxoSmithKline, is the most common branded version.

It is tightly controlled and its use in the US is heavily regulated because of its potential dangers.

‘NSAIDs may cause 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] may 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 the supplements after it performed lab testing in January.

It notes that the sample it tested was purchased directly from Amazon.

In June, Latin Foods Market – which manufactures the products – issued a nationwide recall of some lots of the drug.

Products remained on some markets though, and Amazon allowed their sale to continue, breaking FDA rules.

‘You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations,’ the FDA warned Mr Jassy

‘It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.’