The Food and Drug Administration is warning consumers not to buy or use “gas station heroin” or tianeptine products, including Neptune’s Fix, following reports of “seizures, loss of consciousness and death.” Photo courtesy of the U.S. Food and Drug Administration
The U.S. Food and Drug Administration has issued a new warning to consumers not to buy or use tianeptine products, including Neptune’s Fix, following reports of “seizures, loss of consciousness and death.”
“The agency is actively investigating adverse event reports in conjunction with local and state health departments,” the FDA said in a statement Tuesday. “These products may interact, in life-threatening ways, with other medications a consumer may be taking.” Advertisement
The FDA sent a letter on Jan. 11, to convenience stores, gas stations and other organizations urging them to stop selling Neptune’s Fix and any other tianeptine-containing dietary supplements or products.
Tianeptine, which is commonly known as “gas station heroin,” is an antidepressant that is approved in some European, Asian and Latin American countries. It is not approved in the United States and is not regulated by the FDA.
The ingredient can be found illegally as a dietary supplement, which is marketed as a way “to improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions,” according to the FDA.
The U.S. Centers for Disease Control and Prevention warns tianeptine can mimic opioid toxicity and withdrawal, causing side effects in the nervous system, heart and stomach. Advertisement
Neptune Resources has agreed to voluntarily recall all lots of Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir and Neptune’s Fix Tablets.
“Consumers, distributors and retailers that have these products should either dispose of them or return them to place of purchase immediately,” the FDA said.
The FDA issued a warning about tianeptine products in November following a number of reports of serious reactions and loss of consciousness, requiring hospitalization.
In the last five years, there have been about 1,100 “human exposures” involving tianeptine reported to U.S. poison centers, with the number of exposures increasing each year, according to a statement Wednesday by Maggie Maloney, a spokesperson for America’s Poison Centers.
“Most cases of tianeptine exposures reported to U.S. Poison Centers involved adults intentionally using the substance to get high,” Maloney said.
Last week, Reps. Jeff Jackson, D-N.C., and Rich McCormick, R-Ga., urged the FDA to take action.
“The urgent need for FDA action on tianeptine cannot be overstated,” Jackson and McCormick wrote in a letter to FDA Commissioner Dr. Robert Califf.
“It is vital to support legislative or administrative initiatives that strengthen FDA oversight and provide states greater ability to protect our communities from the dangers posed by substances like tianeptine.” Advertisement
