FDA says ‘dangerous’ substance known as ‘gas station heroin’ poses major risk to young people

The caput of the U.S. Food and Drug Administration (FDA) is sounding the alarm connected a unsafe cause referred to arsenic "gas presumption heroin," that tin pb to superior harm, including death.

FDA Commissioner Martin A. Makary sent a missive to his colleagues past week to gully their attraction to what helium called a "dangerous and increasing wellness trend" facing the federation and young people. Makary said determination is an expanding fig of adverse events involving products that incorporate tianeptine.

Tianeptine, often called "gas presumption heroin," is sold successful state stations done a assortment of products, contempt the cause not being approved by the FDA.

"I americium precise concerned," Makary wrote. "I privation the nationalist to beryllium particularly alert of this unsafe merchandise and the superior and continuing hazard it poses to America’s youth."

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The "supplement" commonly goes by the marque names ZaZa oregon Tianna Red. (Dekalb County Sheriff's Office)

The products are typically sold astatine convenience stores, state stations, vape shops and online retailers, and spell by names similar Tianaa, ZaZa, Neptune’s Fix, Pegasus and TD Red.

Makary said the FDA is pursuing the organisation and merchantability of products that incorporate tianeptine but called connected his colleagues to disseminate accusation astir the cause portion appreciating the magnitude of its underlying danger.

Tianeptine is licensed and marketed successful immoderate countries arsenic an atypical antidepressant, and successful countries wherever it is approved, the emblematic labeled dose to dainty slump is 12.5 mg orally, 3 times per day, Makary said.

When higher doses are taken, they tin nutrient euphoria. Some countries person taken steps to restrict however tianeptine is prescribed oregon dispensed and person adjacent revised the labels to pass radical of its imaginable addiction.

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The FDA is informing astir the dangers of tianeptine. (REUTERS/Andrew Kelly/File Photo)

In the U.S., though, tianeptine is not listed arsenic portion of the Controlled Substances Act.

The cause is often taken recreationally, though if stopped abruptly, users could acquisition withdrawal symptoms akin to those associated with opioid withdrawal – craving, sweating, diarrhea and more.

If tianeptine is ingested, Makary wrote, adverse events could see agitation, coma, confusion, death, drowsiness, hypertension, nausea, respiratory depression, sweating, tachycardia and vomiting.

Two years ago, New Jersey wellness officials warned that 2 products sold arsenic dietary supplements successful state stations and online – Neptune’s Elixir and ZaZa Red – had caused a spike successful illnesses.

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New Jersey wellness officials raised concerns successful 2023 astir Neptune’s Fix Elixir, a merchandise containing tianeptine, aft a clump of illnesses was reported successful transportation with the product. (FDA's Office of Regulatory Affairs, Health Fraud Branch)

Between June and November 2023, determination were 20 reported cases of tianeptine causing "severe objective effects" successful New Jersey, arsenic noted successful a Feb. 1 alert from the U.S. Centers for Disease Control and Prevention (CDC). 

In 2023, the FDA posted an alert informing of the dangers of Neptune’s Fix oregon immoderate different merchandise containing tianeptine.

"FDA has received terrible adverse lawsuit reports aft usage of Neptune’s Fix products, including seizures and nonaccomplishment of consciousness starring to hospitalization," the bureau stated.

"FDA considers tianeptine to beryllium a substance that does not conscionable the statutory explanation of a dietary constituent and is an unsafe nutrient additive. The FDA is alert of respective superior adverse lawsuit reports associated with tianeptine."

On Jan. 28, 2024, Neptune Resources, LLC, the shaper of Neptune’s Fix, issued a voluntary callback of its products owed to the beingness of tianeptine — but experts are informing that different products whitethorn besides incorporate the drug.

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Anyone who is utilizing tianeptine oregon a merchandise containing tianeptine and is experiencing withdrawal symptoms tin telephone the National Poison Control Center astatine 1-800-222-1222 oregon question exigency aesculapian assistance, experts advised.

Fox News Digital’s Melissa Rudy contributed to this report.