The Food and Drug Administration (FDA) is sounding the alarm on tianeptine, a synthetic drug commonly known as “gas station heroin.” This substance, sold in tablet or powder form, is readily available online and in convenience stores, gas stations, and smoke shops. While tianeptine is approved as a prescription drug for depression treatment in certain countries, it possesses properties that mimic opioids like fentanyl, thereby carrying the same risks of addiction, overdose, and withdrawal. Moreover, it can result in severe consequences such as psychosis, seizures, kidney damage, and even death. Despite the FDA’s active efforts to dissuade consumers from using the drug since 2022, vendors persist in promoting it as a dietary supplement. However, the FDA explicitly states that tianeptine fails to meet the definition of a dietary ingredient and is an unsafe food additive.
The Conversation recently sought the insights of C. Michael White, a pharmacist specializing in the study of substance abuse and natural products, to shed light on the growing health hazards associated with products containing tianeptine. Tianeptine targets the same receptors as well-known opioids like heroin, fentanyl, and morphine. Upon reaching the brain, these drugs bind to the “mu” type opioid receptor, leading to both the desired pain relief and euphoric effects, as well as dangerous consequences like respiratory depression. Tianeptine, when consumed in high doses, can induce effects akin to heroin, including a dissociative state where individuals feel disconnected from their surroundings and bodies. This dissociation is reminiscent of the usage of ketamine, an anesthetic employed in treating post-traumatic stress disorder and depression, but often abused as a street drug. Commonly referred to as “legal high drugs” or colloquially as “gas station drugs,” products containing tianeptine fall under the larger category of non-FDA-approved synthetic drugs that are casually sold in gas stations, online, and elsewhere.
Clinical trials, case reports, and poison control centers have provided crucial data indicating that tianeptine use frequently triggers restlessness and agitation. These symptoms are accompanied by an increased heart rate, elevated blood pressure, confusion, nightmares, drowsiness, dry mouth, and nausea, among other conditions. Yet, the most severe adverse events include respiratory depression, coma, arrhythmia, and even death. Individuals who have engaged in long-term tianeptine use often experience withdrawal symptoms similar to those associated with opioids. Moreover, consumers should recognize that products containing tianeptine are not necessarily manufactured with proper standards. As a consequence, such products may contain lead or other heavy metal contaminants, as well as microorganisms like salmonella or mold. Additionally, undisclosed drug ingredients may be present, further elevating the risk of adverse effects. Combining active ingredients, whether intentional or accidental, greatly amplifies the chances of harm. Even with products from the same manufacturer, there can be substantial variations in the amount of active ingredient present, making previous use an unreliable indicator of how much to consume.
If a drug product lacks FDA approval for either prescription or over-the-counter use, it falls under the purview of the Drug Enforcement Agency (DEA) to control its market access. For the DEA to ban an active ingredient in a drug product, it must designate it as Schedule I, meaning the drug serves no legitimate medical purpose and has a high potential for abuse. Manufacturers are not obligated to inform the DEA prior to selling their products to US citizens. Consequently, the DEA must identify an issue, pinpoint the products causing the problem, determine the active ingredients, and conduct a comprehensive scientific review before classifying it as Schedule I. Tianeptine successfully penetrated the market disguised as a dietary supplement, finding its way into gas stations and smoke shops, despite being a synthetic compound. Online sales purportedly for research purposes, rather than human consumption, also contribute to the proliferation of tianeptine use. Although the drug is currently undergoing clinical trials for pain and depression treatment, sellers make no effort to clearly label their products as such or limit purchases to researchers.
Steer Clear of Non-FDA-Approved Synthetic Drugs
Using non-FDA-approved products containing synthetic drugs poses significant risks and should be avoided. FDA-approved drugs are only available through prescriptions from healthcare professionals or over the counter, with active ingredients strictly regulated. If someone in a gas station, smoke shop, or online markets a non-FDA-approved drug product, claiming it provides relief for pain, anxiety, increased energy, or a buzz, exercise caution. The drug could be dangerous on the first use, and even a successful initial experience does not guarantee the same outcome on subsequent uses. Furthermore, continued usage increases the likelihood of addiction. Products labeled as “not for human consumption” or “for research purposes only” carry a high risk if ingested. Before consuming any dietary supplement, ensure that the active ingredient is a natural product rather than a synthetic chemical. Be wary if someone possesses unmarked pouches of powder, labels intended for research purposes or not for human consumption, or tablets and capsules in non-standard drug containers. Standard drug tests available over the counter may not detect the presence of tianeptine. One reason people turn to these alternative substances of abuse rather than conventional opioids, cannabis, or amphetamines is their difficulty to detect through work or at-home drug screens conducted by parents, schools, employers, and probation officers. In cases where the DEA’s response to emerging threats is insufficient, individual states can take action and ban the sale of products containing dangerous active ingredients. Currently, at least 12 states have prohibited the sale of tianeptine, according to the FDA. However, individuals in those states may still unlawfully obtain the substance via the internet. Therefore, contacting state legislators stands as an initial step to exercise one’s power in mitigating the harms associated with these products.
Leave a Reply