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.
- The .gov means it’s official.Federal government websites often end in .gov or .mil.
- 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.
- In about 40% of cases, the person had to seek medical care, with more than half of them needing critical care.
- View Flickr for more photos of Neptune’s Fix and other tianeptine products.
- FDA recommends that health care professionals encourage patients to avoid all products containing tianeptine, including those claiming to treat an ailment or disorder.
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.
- These products may also interact, in life-threatening ways, with other medications a consumer may be taking.
- 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.
- The FDA warns physicians about unapproved tianeptine products that are linked to severe adverse events, including dependence, toxicity, and death.
- 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.
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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.
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.
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View Flickr for Neptune’s Fix photos distributed by Super Chill Products and Neptune Resources and other tianeptine products. People dealing with opioid addiction, pain, depression, anxiety and other conditions should see a health professional to get a prescription for FDA-approved treatments, Hays said. Although other countries have approved tianeptine to treat depression and anxiety, some have restricted how tianeptine is prescribed or dispensed, or warned of possible addiction. 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. Historically, there has been a delayed recognition of fast-growing trends, such as opioid abuse and vaping addiction in youth.
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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.
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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.
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.
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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 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.
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.
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 tianeptine products linked to harm 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.
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.
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.