The Food and Drug Administration’s commissioner, Marty Makary, sent out a warning Thursday about tianeptine, also called “gas station heroin.”
The substance, licensed in some countries as an antidepressant, isn’t listed under the Controlled Substances Act and isn’t approved by the FDA as a medicine or for use in food. It also doesn’t meet the FDA’s criteria for dietary ingredients, Mr. Makary said in his letter.
Despite this, tianeptine products are marketed and sold in gas stations, convenience stores, vape shops and online as dietary supplements, cognitive enhancers and research chemicals.
Citing medical literature, Mr. Makary said some U.S. consumers of tianeptine take 1.3 to 250 times the dose recommended abroad as an antidepressant.
The chemical produces a euphoric feeling similar to that of opioids, hence its nickname. It can also be addictive and give people withdrawal symptoms akin to opioid withdrawal, including diarrhea, sweating, craving and muscle aches.
In 2024, multiple suppliers of the tianeptine product Neptune’s Fix recalled their products after the FDA got reports of the products causing seizures, loss of consciousness, abnormally high heart rate, low blood pressure and death.
Mr. Makary recommends doctors warn their patients against using tianeptine recreationally or to self-treat ailments.
“Historically, there has been a delayed recognition of fast-growing trends, such as opioid abuse and vaping addiction in youth. Let’s be proactive in understanding and addressing the use of tianeptine products, which are available even to our nation’s youth,” Mr. Makary wrote.
