The U.S. Food and Drug Administration issued a stark warning about the growing use of tianeptine, a dangerous and unapproved drug being sold under names like Zaza, Neptune’s Fix, and Tianaa.
Commonly referred to as “gas station heroin,” the drug is easily found at convenience stores, vape shops, and online — and is increasingly linked to serious adverse health effects, including death.
“I am very concerned,” wrote FDA Commissioner Dr. Martin Makary in a May 8 letter. “I want the public to be especially aware of this dangerous product and the serious and continuing risk it poses to America’s youth.”
Tianeptine is not FDA-approved for any medical use in the U.S. and is not scheduled under the Controlled Substances Act. Despite this, it’s being marketed as a “nootropic,” “research chemical,” or dietary supplement — often taken in doses far higher than what is prescribed in other countries, where it’s used as an atypical antidepressant.
Medical reports have documented U.S. users ingesting doses up to 250 times higher than the labeled foreign dose, sometimes leading to coma, seizures, tachycardia, respiratory depression, and death. “Tianeptine may not be identified in routine drug screening panels,” the letter notes.
In 2024, a cluster of serious illnesses in New Jersey tied to Neptune’s Fix revealed the product also contained synthetic cannabinoid receptor agonists. Reported symptoms included hypotension, prolonged QT interval, seizure, and death.
The FDA has issued import alerts and warning letters to manufacturers and continues to monitor the distribution of tianeptine products. Makary urged healthcare professionals to report any adverse events and talk to patients about the dangers of these products and available treatment options.
“Let’s be proactive in understanding and addressing the use of tianeptine products, which are available even to our nation’s youth,” Makary wrote.