The Food and Drug Administration (FDA) is issuing a heightened warning to consumers about the dangers of tianeptine, a synthetic drug commonly referred to as “gas station heroin.” This drug is often sold in tablet or powder form and can be purchased online, as well as in convenience stores, gas stations, and smoke shops. Despite being approved in some countries as a prescription drug for depression, tianeptine carries significant risks similar to opioids like fentanyl. These risks include addiction, withdrawal, overdose potential, psychosis, seizures, kidney damage, and even death. The FDA has been actively urging consumers to avoid this drug since 2022. However, vendors continue to promote tianeptine as a dietary supplement, disregarding the FDA’s explicit statement that it is an unsafe food additive and does not meet the definition of a dietary ingredient.
Pharmacist C. Michael White, an expert in substances of abuse and natural products, sheds light on the growing health risk associated with tianeptine-containing products. Tianeptine stimulates the same receptors as well-known opioids like fentanyl, heroin, and morphine. By binding to the “mu” type opioid receptor in the brain, these drugs provide pain relief and euphoria but also pose dangerous effects such as slowed or stopped breathing. High doses of tianeptine can induce euphoric effects similar to heroin and even lead to dissociation, a state where individuals feel disconnected from their surroundings and body. Tianeptine-containing products are often referred to as “legal high drugs” or “gas station drugs,” which alludes to their casual availability in gas stations, online platforms, and other unregulated markets.
Data from clinical trials, case reports, and poison control centers reveal common adverse effects associated with tianeptine use. These effects include agitation, elevated heart rate, high blood pressure, confusion, nightmares, drowsiness, dry mouth, and nausea. However, the most severe adverse events encompass slowed or stopped breathing, coma, heart arrhythmia, and even death. Additionally, products containing tianeptine may not adhere to good manufacturing practices, potentially leading to heavy metal contamination or the presence of microorganisms like salmonella or mold. Furthermore, these products may also contain undisclosed drug ingredients, increasing the risk of adverse events. It is crucial to note that the actual amount of the active ingredient can vary significantly, even within products from the same manufacturer. Therefore, previous use does not guarantee consistent effects.
The responsibility of controlling the market access of non-FDA-approved drug products falls on the Drug Enforcement Agency (DEA). However, manufacturers are not required to notify the DEA before selling their products to US citizens, making it challenging for the agency to proactively prevent their distribution. To designate an active ingredient as Schedule I, indicating its high abuse potential and lack of medical purpose, the DEA must first detect issues related to the product, identify the active ingredients involved, and conduct a comprehensive scientific review. Tianeptine was initially marketed as a dietary supplement, concealing its true nature as a synthetic compound, and its online sales were allegedly positioned for research purposes rather than human consumption. This lack of transparency and labeling clarity further exposes consumers to potential harm.
Non-FDA-approved products containing synthetic drugs pose significant risks and should be avoided. FDA-approved drugs are available through prescriptions from healthcare professionals or over-the-counter with pre-approved active ingredients. Caution must be exercised when encountering individuals in gas stations, smoke shops, or the internet who promote the benefits of non-FDA-approved drug products. These substances claim to offer pain relief, anxiety reduction, increased energy, or a buzz, but can be dangerous even with the first use. Continued usage can lead to addiction, and the unpredictability of effects makes it particularly hazardous. Products labeled as “not for human consumption” or “for research purposes only” signify a high risk if consumed.
It is essential to exercise vigilance when encountering suspicious products or situations involving tianeptine. If someone you know possesses unmarked powder bags, research-labeled products or non-standard drug containers like tablets or capsules, these could be signs of a potentially dangerous situation. Moreover, standard drug tests available over-the-counter are often unable to detect tianeptine, making it a preferred alternative for individuals seeking substances of abuse that are less likely to be detected through workplace or at-home drug screens. In cases where the DEA lags in responding to emerging threats, individual states can independently ban the sale of dangerous active ingredients in products. While some states have already taken measures to ban tianeptine sales, illegal procurement through the internet still poses a hurdle. Contacting state legislators can be an effective way to exercise influence and contribute to preventing harm caused by these products.