FDA issues another warning on tianeptine products, which can cause seizures and death

Reiterating a warning first issued in November, the U.S. Meals and Drug Administration is urging Individuals to avoid dietary supplements containing tianeptine, recognized on the road as “gasoline station heroin.”

The dietary supplements, bought below the model title Neptune’s Repair on-line and at gasoline stations and convenience stores, could cause seizures, unconsciousness and even demise.

“FDA is warning shoppers to not buy or use any Neptune’s Repair merchandise, or every other product with tianeptine—a probably harmful substance that isn’t FDA-approved for any medical use however is illegally bought with claims to enhance brain function and deal with nervousness, despair, ache, opioid use disorder and different situations,” the company stated in its November assertion.

Updating that warning on Wednesday, the FDA stated it “continues to obtain extreme antagonistic occasion studies after use of Neptune’s Repair merchandise.”

Based on the U.S. Facilities for Illness Management and Prevention, tianeptine is an antidepressant utilized in Europe, Asia and Latin America, nevertheless it has by no means been authorized for any medical use in the US.

“A number of case studies have reported extreme antagonistic results and even demise from leisure abuse of tianeptine,” the CDC stated.

Neptune Assets LLC, the maker of the merchandise, “has agreed to voluntarily recall all a lot of Neptune’s Repair Elixir, Neptune’s Repair Additional Power Elixir and Neptune’s Repair Tablets,” in keeping with the FDA. The company additionally despatched notices on Jan. 11 to comfort shops, gasoline stations and different retailers to cease promoting the merchandise.

It is not simply the energetic ingredient tianeptine that worries the FDA.

“Neptune’s Repair labels state the product incorporates tianeptine, however the product might comprise different dangerous substances not listed on the label,” the company stated.

Additionally, “these merchandise might work together, in life-threatening methods, with different drugs a shopper could also be taking,” the company added.

Talking with NBC Information, Dr. Pieter Cohen, an affiliate professor at Harvard Medical College, known as the risk from tianeptine one other signal of weak oversight of dietary dietary supplements on this nation.

Dietary dietary supplements wouldn’t have to bear FDA approval nor are they examined for security or effectiveness.

The FDA’s “instruments are extraordinarily restricted,” stated Cohen, who research the regulation of dietary supplements. “They’re principally in a scenario the place they should ask the corporate politely if they will take it off the market.”

Assist could also be at hand from Congress, nevertheless: On Jan. 18, 5 members of Congress despatched a letter to FDA Commissioner Dr. Robert Califf urging extra motion on tianeptine.

The drug “has opioid-like qualities and is extraordinarily addictive. We urge the FDA to take instant motion to analysis and supply steerage on tianeptine use,” the legislators wrote.

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