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.
- Although the FDA has warned consumers about tianeptine, vendors continue to market and sell tianeptine for medical uses.
- Internationally, it is marketed as an atypical antidepressant with a labeled dose of 12.5 mg orally three times daily.
- Tianeptine may be referred to as “gas station heroin.” In some places it is labeled as a dietary supplement that enhances cognition and stabilizes mood.
- In the U.S., reports of severe side effects involving tianeptine are increasing.
- Mixing these substances may lead to increased heart rate, lowered blood pressure, seizures and cardiac arrest.
Tianeptine Has Safety Risks and Can Be Abused
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.
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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.
- 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.
- The FDA is aware that tianeptine has been sold online – in pill, liquid and powder forms.
- 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.
- View Flickr for Neptune’s Fix photos distributed by Super Chill Products and Neptune Resources and other tianeptine products.
- Historically, there has been a delayed recognition of fast-growing trends, such as opioid abuse and vaping addiction in youth.
- Neptune’s Fix labels state the product contains tianeptine, but the product may contain other harmful ingredients not listed on the label.
Consumer health
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.
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Neptune’s Fix labels state the product contains tianeptine, but the product may contain other harmful ingredients not listed on the label. These products, like other tianeptine products, can be purchased online and at gas stations, vape or smoke shops, or other locations. FDA is testing these products and will provide more information as it becomes available. Cases described in medical journals, in calls to U.S. poison control centers and in reports to the FDA suggest that tianeptine has a potential for abuse.
Tianeptine is sometimes misused to self-treat withdrawal symptoms from alcohol and other substances. People with a history of substance misuse are at a higher risk of misusing tianeptine. Although tianeptine is not approved in the U.S., it can be bought online and at small stores. Tianeptine may be referred to as “gas station heroin.” In some places it is labeled as a dietary supplement that enhances cognition and stabilizes mood. Tianeptine also may be labeled to help with pain, decrease appetite and increase sexual performance.
Last year, Calello and her colleagues published a study documenting a cluster of emergency calls in New Jersey tied to a flavored elixir called Neptune’s Fix. People experienced distress, rapid heartbeat, low blood pressure and seizures after drinking it. More than a dozen of the 20 patients had to be admitted for intensive care. Additionally, the drug cannot legally be added to foods and beverages or sold as a dietary supplement — something the FDA has repeatedly warned U.S. companies about. Tianeptine is approved in a number foreign countries as an antidepressant, usually as a low-dose pill taken three times a day. But it has never been approved by the FDA for any medical condition in the U.S.
When taken in small doses, tianeptine may help with symptoms of anxiety, depression and irritable bowel syndrome. When taken at higher doses, tianeptine can cause a high or a feeling of euphoria. While tianeptine is not an opioid, the drug binds to some of the same receptors in the brain, which can temporarily produce effects akin to oxycodone and other opioids. Tianeptine also carries some of the same physiological risks of opioids, including the potential to dangerously depress breathing. Tianeptine is not included in the federal Controlled Substances Act, which bans or restricts drugs that have no medical use or have a high potential for abuse, such as heroin, LSD and PCP. But about a dozen states have passed laws prohibiting or restricting tianeptine, including Alabama, Georgia, Michigan, Minnesota, Ohio and Tennessee.
People with a history of opioid use disorder or dependence may be at particular risk of abusing tianeptine. FDA has received severe adverse event reports after use of tianeptine products linked to harm Neptune‘s Fix products, including seizures and loss of consciousness leading to hospitalization. Consumers who experience a bad reaction to any tianeptine product should seek immediate medical help. Tianeptine is not approved by the FDA for any indication, is not recognized as safe for use in food, and does not qualify as a dietary ingredient under U.S. law. Internationally, it is marketed as an atypical antidepressant with a labeled dose of 12.5 mg orally three times daily. It exhibits mu-opioid receptor agonist activity, and supratherapeutic doses have been linked to euphoria and dependence.
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Poison control center cases involving tianeptine exposure have increased nationwide, from 11 total cases between 2000 and 2013 to 151 cases in 2020 alone. These products may also interact, in life-threatening ways, with other medications a consumer may be taking. The agency is actively investigating adverse event reports in conjunction with local and state health departments. Consumers should not purchase or use any Neptune’s Fix products, or any other product with tianeptine – a potentially dangerous substance that is not FDA-approved for any medical use.
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.
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 issued warning letters to companies distributing and selling unlawful tianeptine products as dietary supplements and unapproved drugs.