food and drug administration issued a new warning late Tuesday. About supplements containing the ingredient tianeptine, commonly known as “gas station heroin.” The product, sold under the name Neptune's Fix and commonly found at gas stations, convenience stores and online, can cause serious side effects including seizures, loss of consciousness and death.
The FDA first warned about tianeptine-containing products in November, but said it continues to receive reports of people being poisoned by the supplement.
Tianeptine is an antidepressant. approved It is available in some countries in Europe, Asia, and Latin America, but not in the United States.
According to , the substance can cause side effects on the nervous system, heart, and stomach, and some effects mimic opioid toxicity and withdrawal symptoms. Centers for Disease Control and Prevention.
According to the FDA, the product is illegally found in the United States as a dietary supplement and is sold by retailers as a way to “improve brain function and treat anxiety, depression, pain, opioid use disorder, and other conditions.” It is said that it is often sold.
The FDA announced in November that it was investigating reports of serious reactions, including seizures and loss of consciousness that led to hospitalization.
“These products can interact in life-threatening ways with other medications consumers are taking,” the FDA said in a statement. “The agency actively investigates reports of adverse events in cooperation with local and state health departments.”
Dr. Peter Cohen, an associate professor at Harvard Medical School who studies supplement regulation, said the illegal sale of tianeptine is “evidence of a broken system.”
Dietary supplements sold in the United States are not approved by the FDA and have not been reviewed for safety and effectiveness by the FDA.
Cohen said the FDA's “recourse is very limited.” “They're basically in a situation where they have to politely ask the company if they can exit the market.”
The agency announced Tuesday that Neptune Resources, the maker of Neptune's Fix, has agreed to a voluntary recall of its products, including Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets.
It's unclear whether the product is still available in stores. The FDA did not respond to requests for comment.
However, the FDA said at least 12 states have banned the sale of tianeptine.
Additionally, the agency sent a letter to convenience stores, gas stations, and other retailers on January 11 asking them to stop selling Neptune's Fix and other products containing tianeptine.
The FDA warning came less than a week later. Congressmen called out FDA Commissioner Dr. Robert Califf Crack down on the use of tianeptine.
