The Commissioner of Food and Drugs has released a sobering warning about the growing threat of tianeptine-containing products—often referred to as “gas station heroin.” These products have been linked to a rising number of serious adverse health events, including deaths, prompting urgent concern from the U.S. Food and Drug Administration (FDA).

Tianeptine: An Unapproved and Dangerous Substance

Tianeptine is not approved for any use in the United States. The FDA does not recognize it as safe for inclusion in food or dietary supplements. Nevertheless, it is being sold under misleading labels such as “research chemical,” “nootropic,” or as a dietary supplement. Products containing tianeptine are readily available online and at everyday retailers such as gas stations, convenience stores, and vape shops. Common brand names include Tianaa, Zaza, Neptune’s Fix, Pegasus, and TD Red.

Although tianeptine is prescribed as an antidepressant in some countries, it poses significant dangers, particularly at high doses. U.S. users often consume much larger quantities than those typically prescribed abroad, increasing the risk of serious health consequences. At elevated levels, tianeptine can mimic opioid-like effects, leading to dependency, addiction, and potentially life-threatening outcomes.

Mounting Health Risks and Alarming Case Clusters

The FDA has documented a wide array of adverse effects tied to tianeptine use, including confusion, coma, agitation, respiratory depression, vomiting, hypertension, tachycardia, and death. One recent cluster of illnesses in New Jersey, associated with a product called “Neptune’s Fix,” led to multiple hospitalizations and deaths. This product was found to contain both tianeptine and synthetic cannabinoids. Patients experienced severe symptoms including seizures, hypotension, and heart rhythm disturbances.

Making matters worse, tianeptine is often undetectable in standard drug screenings, complicating diagnosis and treatment in emergency settings.

FDA Action and Call to Healthcare Providers

To combat the growing threat, the FDA has issued consumer alerts, sent warning letters to businesses selling these dangerous products, and implemented import alerts to block their entry into the U.S.

Healthcare professionals are urged to take proactive steps, including:

• Advising patients to avoid all tianeptine products.
• Offering evidence-based treatment options for conditions such as depression, anxiety, pain, and substance use disorders.
• Ensuring patient access to naloxone in case of overdose.
• Reporting adverse reactions through the FDA’s MedWatch system and including detailed product and purchase information.

A Call to Prevent Another Public Health Crisis

The Commissioner’s letter highlights the need for vigilance, particularly among youth populations. It draws stark comparisons to the delayed responses to the opioid and vaping epidemics, urging immediate action to prevent another preventable crisis.

Consumers, families, and healthcare providers can learn more and report issues through the FDA’s MedWatch program and by reading the educational article, “Tianeptine Products Linked to Serious Harm, Overdoses, Death.”

For clinical advice or in the event of a suspected overdose, individuals are encouraged to contact the Poison Help Line at 1-800-222-1222.

https://www.fda.gov/consumers/health-fraud-scams/new-gas-station-heroin-tianeptine-product-trend