FDA warns against using Neptune’s Fix or tianeptine products known as ‘gas station heroin’

FILE - A sign in front of the Food and Drug Administration building is seen on Dec. 10, 2020, in Silver Spring, Md. Expedited drug approvals slowed in 2022, as the FDA's controversial accelerated pathway came under new scrutiny from Congress, government watchdogs and some of the agency’s own leaders. With less than a month remaining in the year, the agency’s drug center has granted 10 accelerated approvals — fewer than the tally in each of the last five years, when use of the program reached all-time highs. (AP Photo/Manuel Balce Ceneta, File)
A sign in front of the Food and Drug Administration building is seen on Dec. 10, 2020, in Silver Spring, Md. (AP Photo/Manuel Balce Ceneta)

CORRECTION: The Food and Drug Administration is warning consumers against purchasing or using Neptune’s Fix or any tianeptine products. An earlier version of this story included incorrect information.

The Food and Drug Administration (FDA) is urgently warning consumers against using Neptune’s Fix or any other products include tianeptine, an ingredient informally known as “gas station heroin.”

Supplements containing tianeptine are commonly sold under the brand name Neptune’s Fix at gas stations and convenience stores. The FDA warned the use of the products has been linked to severe side effects, including seizures, loss of consciousness and death.

“These products may interact, in life-threatening ways, with other medications a consumer may be taking. The agency is actively investigating adverse event reports in conjunction with local and state health departments,” the FDA wrote in its warning.

The FDA noted that Neptune Resources, the supplements’ manufacturer, has voluntarily agreed to recall all remaining lots of Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir and Neptune’s Fix Tablets. The agency had previously sent a letter to gas stations and convenience stores urging them to stop selling the products earlier this month.

The FDA initially warned consumers last November not to purchase Neptune’s Fix or other products containing tianeptine, saying it was a “potentially dangerous substance” that is “illegally sold with claims to improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions.”

Tianeptine is not approved for any medical use in the United States, according to the FDA and the Centers for Disease Control and Prevention (CDC). The CDC said that serious side effects associated with tianeptine have been increasing, noting that there were 151 cases of tianeptine exposure reported to poison control centers in 2020 alone.

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