The U.S. Food and Drug Administration (FDA) has issued a strong warning to consumers against the use of tianeptine (tie-uh-NEP-teen), a substance sometimes misleadingly referred to as "gas station heroin." The agency emphasizes that tianeptine is not FDA-approved for any medical use in the United States and poses significant health risks, including death. Back in January, 2024, the FDA issued a recall on Neptune's supplements that contain tianeptine.
Despite its unapproved status, the FDA is concerned that some companies are unlawfully distributing and selling tianeptine-containing products, often in high doses, to consumers online and even in retail locations like gas stations. These products are frequently marketed with dangerous and unproven claims of improving brain function and treating conditions such as anxiety, depression, pain, and opioid use disorder.
The FDA stresses that the easy availability of a product is not an indication of its safety or effectiveness, particularly in the case of tianeptine. Reports of adverse reactions and unwanted effects involving tianeptine are increasing in the U.S. Data from the National Poison Data System shows a dramatic rise in annual poison control center cases related to tianeptine exposure, from just 4 cases in 2013 to approximately 350 cases in 2024.
The FDA highlights the potential for abuse associated with tianeptine, noting that individuals with a history of opioid use disorder or dependence may be at higher risk. Some people are reportedly using tianeptine as an opioid alternative or to self-treat mental health conditions. However, medical journals and FDA reports indicate that taking tianeptine at doses exceeding those prescribed in countries where it is approved can lead to severe adverse effects. U.S. consumers have been reported to take daily doses significantly higher than recommended.
Furthermore, tianeptine can be difficult to stop using and may cause withdrawal symptoms that mimic opioid toxicity and withdrawal, according to the Centers for Disease Control and Prevention. The FDA has documented cases of serious harmful effects, including agitation, drowsiness, confusion, rapid heartbeat, high blood pressure, slowed or stopped breathing, coma, and death, resulting from the abuse or misuse of tianeptine alone or in combination with other drugs.
To protect the public, the FDA has taken action by warning consumers that tianeptine is an unsafe food additive and not a dietary ingredient. The agency has also issued warning letters to companies illegally marketing tianeptine products as dietary supplements and unapproved drugs, as well as import alerts to help prevent tianeptine shipments from entering the U.S.
The FDA strongly advises consumers to avoid all products containing tianeptine and to consult their healthcare provider for safe and approved treatments for opioid dependence, depression, anxiety, pain, or other health concerns.
Help is available to treat opioid or other substance use disorders. Find state-licensed providers who specialize in treating substance use disorders and addiction at www.findtreatment.gov. Or call 1-800-662-HELP (4357).
