The Food and Drug Administration (FDA) has issued a stark warning about tianeptine, an unapproved drug known as “gas station heroin,” citing its severe health risks, particularly among young people. Despite lacking FDA approval, tianeptine is readily available in convenience stores, gas stations, vape shops, and online retailers across the United States.
Tianeptine, marketed under names like Zaza, Tianaa, and Neptune’s Fix, is often sold as a dietary supplement or mood enhancer. However, the FDA emphasizes that it has not sanctioned tianeptine for any medical use in the U.S. The substance is associated with serious side effects, including agitation, confusion, nausea, vomiting, respiratory depression, coma, and even death.
FDA Commissioner Martin A. Makary expressed deep concern over the drug’s impact, stating, “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.” He further noted, “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.”
In response to the growing threat, the FDA has taken several measures:
- Issuing warning letters to companies distributing and selling unlawful tianeptine products.
- Placing products containing tianeptine on import alert to help detain shipments at U.S. borders.
- Advising consumers to avoid all products containing tianeptine and to seek immediate medical attention if they experience adverse effects.
Healthcare providers are urged to discuss the dangers of tianeptine with patients and to consider treatment options for those struggling with substance use disorders. The FDA also recommends that providers inform patients about the availability of overdose reversal medications, such as naloxone nasal spray.