The Food and Drug Administration is warning the public about the harmful effects of products containing tianeptine, also referred to as "gas station heroin" due to its availability in gas station stores.
Tianeptine is an opioid alternative prescribed as an antidepressant in some Latin American, Asian and European countries. It is not approved by the FDA for any use in the U.S. and can cause a range of adverse events.
"I am very concerned. I want the public to be especially aware of this dangerous product and the serious and continuing risk it poses to America's youth," the FDA's Commissioner of Food and Drugs Dr. Martin A. Makary said in a letter Thursday. "While the FDA is closely following the distribution and sale of these products, it is critical that you appreciate the magnitude of the underlying danger of these products, and disseminate information about it."
According to the letter, tianeptine can lead to serious harm, including death. Other symptoms include agitation, confusion, sweating, nausea, vomiting, drowsiness and coma.
Some product names that include the substance include Tianaa, Zaza, Neptune's Fix, Pegasus and TD Red, the letter said, adding that it is often marketed as a "research chemical," "nootropic" cognitive enhancer or a dietary supplement.
"Case reports in the medical literature describe U.S. consumers ingesting daily doses on the order of 1.3 to 250 times (50 mg to 10,000 mg) the daily tianeptine dose typically recommended in labeled foreign drug products," the letter read.
This isn't the first time these products have made headlines. In 2023, the FDA warned consumers not to use or purchase any products from Neptune's Fix after receiving multiple reports of severe reactions, including seizures and hospitalizations. In 2024, Neptune's Fix products sold nationwide were recalled because of their use of tianeptine.
Sara Moniuszko