Some people have turned to tianeptine as an opioid alternative, or to self-treat anxiety or depression. Medical journals and reports to the FDA suggest that bad effects may occur when tianeptine is taken at doses higher than those prescribed in the countries where the drug has been approved. These reports describe U.S. consumers taking daily doses between 1.3 and 250 times the daily tianeptine dose typically recommended in products approved in other countries.
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Super Chill Products include cherry, lemon, and chocolate vanilla flavors. Still, under-the-radar firms sell tianeptine in various formulas, often with brand names like Zaza, Tianaa, Pegasus and TD Red. Although that is technically illegal, the FDA does not preapprove ingredients added to supplements and beverages.
Despite that, some companies are illegally marketing and selling products containing tianeptine to consumers. FDA recommends that health care professionals encourage patients to avoid all products containing tianeptine, including those claiming to treat an ailment or disorder. While tianeptine may help treat depression, anxiety and irritable bowel syndrome, the risks often outweigh the benefits. Tianeptine is usually sold as a dietary supplement that can help with energy, mood, pain, sexual performance and appetite control.
- Some U.S. consumers have ingested tianeptine at doses up to 10,000 mg daily—more than 250 times the typical therapeutic dose used abroad—despite the drug’s unapproved status and life-threatening risks.
- Despite that, some companies are distributing and selling unlawful products containing tianeptine to consumers, including products with high doses.
- The clinical effects of tianeptine abuse and withdrawal can mimic opioid toxicity and withdrawal, according to the Centers for Disease Control and Prevention.
- WASHINGTON (AP) — Health officials want you to think twice before buying one of those brightly colored little bottles often sold at gas stations, convenience stores and smoke shops.
- Tianeptine, which is often called “gas station heroin” because of its availability in gas station stores, is not approved by the FDA for any use.
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Tianeptine is frequently available at convenience stores, gas stations, vape shops, and online retailers. Product names include, for example, Tianaa, Zaza, Neptune’s Fix, Pegasus, and TD Red. Despite that, some companies are distributing and selling unlawful products containing tianeptine to consumers, including products with high doses. They are also making dangerous and unproven claims that tianeptine can improve brain function and treat anxiety, depression, pain, opioid use disorder, and other conditions. Tianeptine, which is often called “gas station heroin” because of its availability in gas station stores, is not approved by the FDA for any use.
In the U.S., reported ingestion has ranged from 50 mg to 10,000 mg daily. The FDA has taken steps to protect people from tianeptine products, including warning consumers that tianeptine is an unsafe food additive. Many tianeptine products claim— without evidence or FDA approval— to help users treat medical conditions, including addiction, pain and depression.
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Health care professionals can direct members of the public to visit FDA’s MedWatch website to report a problem about an FDA regulated product in general. Neptune Resources, LLC has agreed to voluntarily recall all lots of Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir and Neptune’s Fix Tablets to the consumer level. Consumers, distributors and retailers that have these products should either dispose of them or return them to place of purchase immediately. Until recently, Alabama had the highest rate of tianeptine-related calls in the southern U.S., which increased more than 1,400% between 2018 to 2021. But after the state restricted tianeptine in 2021 calls began modestly decreasing while calls across other southern states continued to climb.
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In addition, tianeptine is not approved by the FDA for any medical use, is not generally recognized as safe for use in food, and does not meet the statutory definition of a dietary ingredient. Nevertheless, tianeptine is being marketed as a “research chemical,” a “nootropic” cognitive enhancer, or a dietary supplement. In the U.S., reports of severe side effects involving tianeptine are increasing.
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We also have issued import alerts to help detain tianeptine shipments at our borders. Some people take tianeptine with opioids, alcohol or other drugs to heighten the effects. Mixing these substances may lead to increased heart rate, lowered blood pressure, seizures and cardiac arrest.
- The FDA has issued warning letters to companies distributing and selling unlawful tianeptine products as dietary supplements and unapproved drugs.
- Experts aren’t sure but national figures show a big rise in emergency calls involving the drug.
- FDA is testing these products and will provide more information as it becomes available.
- It exhibits mu-opioid receptor agonist activity, and supratherapeutic doses have been linked to euphoria and dependence.
- The FDA has identified cases in which people experienced other serious harmful effects from abusing or misusing tianeptine by itself or with other drugs, including antidepressants and antianxiety medicines.
Warnings, Alerts, and Press Releases
Although the FDA has warned consumers about tianeptine, vendors continue to market and sell tianeptine for medical uses. The FDA is aware that tianeptine has been sold online – in pill, liquid and powder forms. FDA sent a letter on Jan. 11, 2024, to convenience store, gas station and other organizations urging retailers to stop selling Neptune’s Fix and any other tianeptine-containing products. View Flickr for more photos of Neptune’s Fix and other tianeptine products. A 2024 cluster of severe illnesses in New Jersey linked to Neptune’s Fix—found to contain both tianeptine and synthetic cannabinoids—highlighted the potential for compounded toxicity.
Let’s be proactive in understanding and addressing the use of tianeptine products, which are available even to our nation’s youth. Calls to poison control centers increased 525% between 2018 and 2023, according to a data analysis published earlier this year. In about 40% of cases, the person had to seek medical care, with more than half of them needing critical care. Some people may have difficulty stopping using tianeptine and may experience withdrawal symptoms. The clinical effects of tianeptine abuse and withdrawal can mimic opioid toxicity and withdrawal, according to the Centers for Disease Control and Prevention.
Some U.S. consumers have ingested tianeptine at doses up to 10,000 mg daily—more than 250 times the typical therapeutic dose used abroad—despite the drug’s unapproved status and life-threatening risks. In the U.S., reports of bad reactions and unwanted effects involving tianeptine are increasing. Annual poison control center cases involving tianeptine exposure, as reported by the National Poison Data System, have increased nationwide, from 4 cases in 2013 to about 350 cases in 2024. The FDA has identified cases in which people experienced other serious harmful effects from abusing or misusing tianeptine by itself or with other drugs, including antidepressants and antianxiety medicines. These effects included agitation, drowsiness, confusion, sweating, rapid heartbeat, high blood pressure, nausea, vomiting, slowed or stopped breathing, coma and death. In the U.S., tianeptine is not currently scheduled under the Controlled Substances Act.
In some cases, those laws have led to more cases of withdrawal among users of tianeptine, which can be chemically addictive. But state data also shows some success in reducing harm tied to the drug. One explanation for the rise in calls is simply that more Americans are using the products. Experts aren’t sure but national figures show a big rise in emergency calls involving the drug. Send a note of thanks to Mayo Clinic researchers who are revolutionizing healthcare and improving patient outcomes.
Before sharing sensitive information, make sure you’re on a federal government site. I want the public to be especially aware of this dangerous product and the serious and continuing risk it poses to America’s youth. While the FDA is closely following the distribution and sale of these products, it is critical that you appreciate the magnitude of the underlying danger of these products, and disseminate information about it. Products distributed by Super Chill Products also are labeled as ‘Neptune’s Fix,’ but the label and packaging might be slightly different than the products distributed by Neptune Resources LLC.
But experts also say that the products are triggering more emergencies as they become more potent and dangerous. And the researchers in New Jersey who analyzed Neptune’s Fix found that the liquid also contained synthetic cannabis and other drugs. The .gov means it’s official.Federal government websites often end in .gov or .mil.
Talk to your healthcare professional if you have questions about care for depression, anxiety or other conditions. The FDA warns physicians about unapproved tianeptine products that are linked to severe adverse events, including dependence, toxicity, and death. The FDA has tianeptine products linked to harm issued warning letters to companies distributing and selling unlawful tianeptine products as dietary supplements and unapproved drugs.
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