April 15, 2024

The U.S. Meals and Drug Administration has issued a renewed warning in opposition to the acquisition or use of any merchandise containing tianeptine, generally known as “fuel station heroin,” just below every week after lawmakers urged the federal physique to take motion in opposition to its use.

Tianeptine is an authorized antidepressant in some nations, however not within the U.S. Nonetheless, it continues to be offered right here beneath model names like Neptune’s Repair, Tianna and Zaza on-line and at comfort shops and fuel stations beneath the guise of being a health-improvement complement. 

U.S. Meals and Drug Administration

The FDA first warned about tianeptine merchandise, particularly from Neptune’s Repair, in November, and late Tuesday, the federal company mentioned it continues to obtain reviews of the merchandise inflicting adversarial results, together with seizures, lack of consciousness and demise. 

Not solely are they persevering with, however reviews of dangerous reactions and undesirable negative effects involving tianeptine are rising nationwide. In line with the FDA, complete poison management middle instances elevated from simply 13 between 2000 to 2013 to 151 instances in 2020 alone.

Regulators say shoppers are drawn to buy tianeptine merchandise because of corporations typically advertising them as therapies to “enhance mind perform and deal with anxiousness, melancholy, ache, opioid use dysfunction, and different situations.” 

However the FDA warns the merchandise can work together with different drugs in a shopper’s physique, together with different antidepressants or anti-anxiety drugs, and trigger dangerous reactions.

Moreover, the CDC factors to proof displaying tianeptine abuse and withdrawal can mimic opioid toxicity and withdrawal. This level was additionally made in a Jan. 18 letter signed by 5 bipartisan Home representatives urging the FDA to extra tightly regulate tianeptine because of its “opioid-like qualities.”

The FDA says these with a historical past of opioid use or dependence could also be at an elevated threat of abusing tianeptine, and that abuse may cause dangerous results together with drowsiness, speedy heartbeat, hypertension, vomiting, slowed or stopped respiration and extra.

“Folks in search of to deal with their illnesses generally mistake a product as being secure as a result of it is simply out there, whether or not on-line and even at fuel stations,” the FDA mentioned. “However availability isn’t any indication of effectiveness or security. That is very true of tianeptine, an unapproved drug related to severe well being dangers and even demise.”

U.S. Meals and Drug Administration

Although the FDA doesn’t approve dietary dietary supplements for security and effectiveness earlier than they’re offered to the general public, it mentioned Tuesday that Neptune Sources — the maker of Neptune’s Repair — has now agreed to voluntarily recall three of its tianeptine merchandise. It additionally mentioned it despatched a letter to comfort shops, fuel stations and different organizations on Jan. 11, urging them to cease promoting Neptune’s Repair and some other tianeptine-containing merchandise.

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