FDA Warns Again About ‘Gas Station Heroin’
/By Pat Anson
The Food and Drug Administration is once again warning Americans about the harmful effects of tianeptine, an antidepressant found in supplements sold online and in convenience stores to help with energy, mood, pain and sexual performance.
Tianeptine is essentially an unregulated drug in the United States. It is not currently scheduled under the Controlled Substances Act, but is also not approved by the FDA for any medical use. It is, however, approved in low doses as a treatment for depression and anxiety in several European, Asian and Latin American counties.
The problem in the U.S. is that tianeptine is being sold in supplements without a prescription at doses up to 250 times higher than what is typically recommended in foreign drug products. At high doses, tianeptine can cause confusion, agitation and euphoria – which has led some to call it “gas station heroin.”
“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,” FDA Commissioner Dr. Martin Makary said in a “Dear Colleagues” letter to healthcare professionals.
“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.”
This isn’t the first time the FDA has warned about tianeptine. In 2023, the agency warned consumers not to purchase or consume tianeptine products sold under the brand name Neptune’s Fix, which it blamed for “severe adverse events” such as seizures and loss of consciousness. A few months later, the FDA sent a warning letter to retailers telling them to stop selling Neptune’s Fix and any other products containing tianeptine.
Makary’s letter does not make clear why another warning about tianeptine is needed. It implies the drug is increasingly used by young people, but provides no statistics or examples of it harming users.
Since 2023, the FDA’s Adverse Events Reporting System has recorded less than a hundred cases of adverse health events involving tianeptine, most of them involving “persistent genital arousal disorder.”
Like other antidepressants, tianeptine can be used to relieve pain. A 2023 study on laboratory mice found tianeptine to be a fast-acting pain reliever, with low risk of addiction.
“We hope this revives the potential of using tianeptine for the treatment of chronic pain and associated conditions, such as anxiety and depression,” said lead author Venetia Zachariou, PhD, Chair of Pharmacology at Boston University’s School of Medicine. “By further refining this molecule, we could arrive at a pain treatment that is more effective, fast acting, and has a mild side effect profile.”
Other studies have show tianeptine may be effective as a treatment for asthma, irritable bowel syndrome, fibromyalgia, and ADHD. Like any drug, however, tianeptine can be harmful when its abused, taken in high doses, or combined with other drugs.
“Tianeptine is often taken recreationally, but it has also been used to self-treat a variety of ailments. It is frequently used chronically and, if stopped abruptly, users may experience withdrawal symptoms,” Makary said in his letter. “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.”
