The FDA warned again about serious side effects linked to an illegal supplement for anxiety and pain sold at gas stations and convenience stores. Products with tianeptine, marketed as an antidepressant and often sold under brand Neptune’s Fix, have been reported to cause seizures and even death. But it turns out that a knock-off is the culprit. ‘ Neptune Resources LLC did NOT have a single serious injure/illness reported. Every serious illness reported was from a counterfeit product made by a New York-based company called Super Chill. My understanding is that their counterfeit product did NOT even contain tianeptine as the label indicated; instead it contained one of the new synthetic cannabinoids and bromazepam. I have plenty of proof that Super Chill is the manufacturer of the counterfeit products that have hurt people but I have had difficulty convincing the FDA to shift their attention to the counterfeiter. see Alexander’s Tin Notes for latest info
Five members of Congress wrote a letter to the FDA asking what it’s doing about tianeptine, an unapproved drug that can cause overdoses and severe withdrawal. – Vice Mag
FDA warns consumers not to purchase or use Neptune’s Fix or any tianeptine product due to serious risks. Here’s the text:
FDA continues to receive severe adverse event reports after use of Neptune‘s Fix products, including seizures, loss of consciousness and death. These products may 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.
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.
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.
Call Poison Help at 1-800-222-1222 to connect to your local poison center.
A bipartisan group of lawmakers recently addressed a letter to the Food and Drug Administration (FDA), expressing concern about the prevalence and dangers associated with the use of a highly addictive substance known as tianeptine. This compound, colloquially referred to as ‘gas station heroin’ and marketed under brand names such as Zaza and Tianna, exhibits opioid-like properties and has sparked worries about its addictive nature.
Tianeptine is often times marketed as a dietary supplement or a mood booster. Lawmakers say it’s highly addictive and poses major health risks- WCNC Charlotte
In their letter dated January 18, the lawmakers emphasized the urgency of the situation and sought information from the FDA on its strategies to tackle the growing issue of tianeptine use. Notably, recent reports have drawn attention to the striking similarities between withdrawal symptoms from tianeptine and those experienced during opioid withdrawal, including nausea, chills, and insomnia. Additionally, emerging medical research has indicated the potential for fatal overdoses linked to tianeptine use.
Tianeptine, initially classified as a tricyclic antidepressant predating the availability of Prozac in the 1980s, differs from serotonin reuptake inhibitors (SSRIs) like Prozac. While SSRIs take weeks to manifest their effects, tricyclic antidepressants such as tianeptine produce immediate results. Dr. Melissa Thompson of the Ivy Creek Detox Program at Elmore Community Hospital in Wetumpka, Alabama, emphasized the rapid development of physical dependence on tianeptine, leading to a complex withdrawal process akin to withdrawing from multiple drugs simultaneously.
It is baffling to see what kind of dangerous pills the FDA will allow to be sold, fully aware of the sied effects!https://t.co/wnYl2K8Uaz "According to a 2023 study led by researchers at Harvard and Louisiana State University, tianeptine-linked overdoses and suicide attempts…
— ♀️ IAmLookingBackAtYou 🇺🇸 🇮🇱 🇩🇪 🇹🇷 🇫🇷 (@WeRAmerica2022) January 24, 2024
Despite being approved in certain European, Asian, and Latin American countries, tianeptine has never received FDA approval for medical use in the United States. This antidepressant is not regulated by the Controlled Substances Act (CSA) or the Drug Enforcement Agency (DEA), yet it remains widely available for purchase. Several states, including Alabama, Michigan, Mississippi, Tennessee, Georgia, Indiana, Ohio, Florida, and Kentucky, have already imposed bans or strict controls on tianeptine sales.
The lawmakers’ letter highlighted the FDA’s issuance of three warnings on tianeptine use over the past five years. These warnings underscored the risk of inadvertent addiction and potential abuse associated with tianeptine. The FDA’s most recent caution in November 2023 specifically discouraged the purchase or use of Neptune’s Fix or any tianeptine product due to severe adverse events reported, including seizures and loss of consciousness leading to hospitalization. But the facts are coming out that a counterfeit product is the cause of all issues.
FDA warns consumers not to purchase or use Neptune’s Fix or any tianeptine product due to serious risks https://t.co/NLh4p1wuUZ
— McFlusion (@McFlusion) January 24, 2024
Acknowledging the FDA’s warnings, the lawmakers emphasized the need for more comprehensive action to safeguard the health and well-being of the American public. They posed specific questions to the FDA regarding its oversight actions, research into tianeptine, the drug’s effects on human health, and whether it should be scheduled under the CSA.
Tianeptine is highly addictive with major risks including overdoses and withdrawal – all without oversight from the FDA. Thanks to @RepMcCormick and our bipartisan group calling for action to protect families from the highly accessible, dangerous drug. – Rep Jeff Jackson
The FDA, in its 2022 warning, highlighted an alarming trend of people turning to tianeptine as an alternative to opioids or for self-treatment of depression and anxiety. Reports of adverse reactions and unwanted effects related to tianeptine have surged in the United States, with poison control center cases rising from 11 between 2000 and 2013 to 151 cases in 2020 alone. Keep in mind that this is the same FDA that criminally recommends the C vaccine for pregnant women, causing deaths all over the United States. It has been said that the FDA has evolved into a wholly owned branch of Big Pharma so we are now at the stage where when one sees FDA, one no longer believes what is being said. Asking who profits is now the rule in dealing with anything that comes out of the FDA or CDC.
To counteract the illicit marketing of products containing tianeptine, the FDA has issued warning letters to companies promoting it as dietary supplements and unapproved drugs. Import alerts have also been issued to prevent the influx of these drugs into the United States.
The dangers associated with tianeptine were recently highlighted in an article by The New York Times, bringing attention to the substance’s potential for abuse and its short-lived euphoric effects when taken in high doses. While approved in some countries as a low-dose antidepressant, tianeptine’s misuse has led individuals to perceive it as a safe alternative to opioids.
#Tianeptine, a.k.a gas station heroin, has not been approved for "any medical use" by the @US_FDA. Abuse of, and withdrawal from, the substance can closely resemble #opioid toxicity and withdrawal, per the @CDC. #Poison Help 1-800-222-1222. https://t.co/MAZX8iBHy2
— USVI Poison Control (@USVIPoison) January 24, 2024
The FDA’s November 2023 warning specifically addressed the illegal sale of tianeptine, claiming it could improve brain function and treat various conditions. Dr. Thompson pointed out that individuals hooked on tianeptine may not fit the stereotypical image of addicts, with users ranging from college students to average people seeking relief from anxiety and depression.
To Sum it all up: the bipartisan lawmakers stress the critical need for swift and comprehensive FDA action on tianeptine to protect communities from the risks posed by this highly addictive substance. The letter underscores the importance of supporting legislative or administrative initiatives that enhance FDA oversight and empower states to address the dangers associated with tianeptine.
- Be prepared for anything, including lockdowns with your own Emergency Med kit – see Wellness Emergency Kit (includes Ivermectin and other essential drugs – get approved over the phone – Dr. McCullough’s company!) 🛑
- Get the Spike Control formula to help you clean your blood out of spike proteins from the vaccine. Proven to clean blood and save lives. 👍 – Whatfinger Sponsor
Major Points Discussed:
- Lawmakers express bipartisan concern over tianeptine, an addictive substance with opioid-like qualities.
- Letter to the FDA urges immediate action to research and provide guidance on tianeptine use.
- Tianeptine, known as ‘gas station heroin,’ raises alarm due to withdrawal symptoms similar to opioids and potential for fatal overdoses.
- Despite being unapproved by the FDA, tianeptine is widely available for purchase, prompting multiple states to impose sales restrictions.
- Lawmakers call for enhanced FDA oversight and legislative initiatives to address the urgent dangers posed by tianeptine, emphasizing the need for public health protection.
Comments – Threads – Links
- FDA warns public not to purchase or use tianeptine products, including Neptune’s Fix – 11 Alive News
- Thank you for letting me know this is out there- EndeavorToPersevere
- Tianeptine is not an approved drug in the United States… Tianeptine has effects beyond improving mood. Its primary mode of operation is not fully or thoroughly known- Narconon Louisiana New Life Retreat
- A group of lawmakers is calling for the FDA to take immediate action on tianeptine, an unapproved drug known as “gas station heroin” because of its opioid-like effects- manisha krishnan
- FDA warns consumers not to purchase or use Neptune’s Fix or any tianeptine product due to serious risks – FDA