The Food and Drug Administration (FDA) is putting forward a heightened sense of urgency in its warnings to consumers against the purchase and consumption of tianeptine, commonly referred to as “gas station heroin.” This synthetic drug is often sold in tablet or powder form and is available 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 poses similar risks to opioids like fentanyl, including the potential for addiction, withdrawal, and overdose. Moreover, its usage can lead to severe consequences such as psychosis, seizures, kidney damage, and even death. Although the FDA has been actively urging consumers to avoid this drug since 2022, numerous vendors continue to market it as a dietary supplement, even though the FDA has explicitly declared that tianeptine is an unsafe food additive and does not meet the definition of a dietary ingredient.
Pharmacist C. Michael White, whose area of study revolves around the harmful effects of substances of abuse and natural products, sheds light on the increasing health risks associated with tianeptine-containing products. Tianeptine acts on the same receptors as well-known opioids like fentanyl, heroin, and morphine. By binding to the “mu” type opioid receptor in the brain, tianeptine triggers not just the desired pain relief and euphoria but also dangerous effects like slowed or stopped breathing. High doses of tianeptine can induce euphoria similar to heroin and even lead to dissociation, a feeling of being disconnected from reality, which is reminiscent of ketamine, an anesthetic commonly abused as a street drug. Given its dangerous nature, products containing tianeptine are often referred to as “legal high drugs” or “gas station drugs.” These terms encompass all non-FDA-approved synthetic drugs casually sold in gas stations, online platforms, and other venues.
Data obtained from clinical trials, case reports, and poison control centers highlight common symptoms induced by tianeptine, including agitation, rapid heart rate, high blood pressure, confusion, nightmares, drowsiness, dry mouth, and nausea. The most severe adverse events associated with tianeptine usage include slowed or stopped breathing, coma, heart arrhythmia, and death. Furthermore, products containing tianeptine often fail to adhere to good manufacturing practices, potentially resulting in lead contamination, heavy metal contamination, or contamination by harmful microorganisms like salmonella and mold. In addition, these products can contain undisclosed drug ingredients, which, when combined with tianeptine, can significantly increase the risk of adverse events. Moreover, the amount of tianeptine present in these products can vary widely, even if they are from the same manufacturer. Therefore, past usage does not guarantee the same effect when using the same amount again.
If a drug product is not approved by the FDA for prescription or over-the-counter use, the responsibility of controlling its market access falls upon the Drug Enforcement Agency (DEA). However, manufacturers are not required to inform the DEA before selling their products to US citizens. As a result, the DEA must actively identify issues, pinpoint the products causing problems, determine the active ingredients, and conduct a comprehensive scientific review before designating the drug as Schedule I, indicating a lack of legitimate medical purpose and high abuse potential. Tianeptine entered the market under the guise of a dietary supplement, even though it is a synthetic compound. It is also sold online, primarily for research purposes, but sellers make no effort to clarify this labeling to consumers or restrict purchases solely to researchers.
It is crucial to avoid using synthetic drugs that lack FDA approval. FDA-approved drugs are available either through a prescription from a healthcare professional or over the counter, with active ingredients on an approved list. If someone promotes the benefits of a non-FDA-approved drug in a gas station, smoke shop, or online, claiming pain relief, anxiety reduction, increased energy, or a buzz, it is important to be cautious. The first use of such products can be dangerous, and successful usage in the past does not guarantee the same outcome in the future. Continued use of these drugs can lead to addiction. Moreover, if a product is labeled as “not for human consumption” or “for research purposes only,” taking it poses a high risk. Before using any dietary supplement, it is essential to confirm that the active ingredient is a natural product and not a synthetic chemical. Unmarked powder, products labeled for research use or not for human consumption, and tablets or capsules not in standard drug bottles are all indications of potentially hazardous situations. It is worth noting that standard drug tests available over the counter are not designed to detect tianeptine. These alternative substances of abuse are appealing to some due to their ability to evade detection through work or home drug screens conducted by parents, schools, employers, probation officers, and other entities.
If the DEA fails to respond promptly to emerging threats, individual states can step in and ban the sale of dangerous active ingredients in products. According to the FDA, as of January 2024, at least 12 states have already banned the sale of tianeptine. However, even in these states, individuals can still illegally obtain tianeptine online. Taking the initiative to contact state legislators can be a proactive step towards exercising power and preventing harm caused by these products.
The FDA’s warnings against the purchase and consumption of tianeptine highlight its resemblance to opioids and the associated risks of addiction, withdrawal, and overdose. The adverse effects of tianeptine usage, including potential contamination and undisclosed ingredients, further emphasize the importance of avoiding non-FDA-approved synthetic drugs. By understanding the risks associated with these substances, individuals can make informed decisions and take steps to protect their health and well-being.
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