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Medscape
13-05-2025
- Health
- Medscape
FDA Issues Warning on ‘Gas Station Heroin' Tianeptine
The US Food and Drug Administration (FDA) has issued a health warning regarding products containing tianeptine, which is often called 'gas station heroin' because of its easy availability at gas station stores. The FDA noted that tianeptine is associated with an increasing number of adverse events, including death, and called its use 'a dangerous and growing health trend facing our nation,' especially for youth. Other associated adverse events cited by the agency include coma, agitation, confusion, hypertension, respiratory depression, tachycardia, and vomiting. 'Historically, there has been a delayed recognition of fast-growing trends,' the FDA wrote in its warning letter. Although it is closely following tianeptine products' distribution and sale, 'it is critical that you appreciate the magnitude of the underlying danger of these products and disseminate information about it,' the agency added. Interestingly, the product is licensed as an atypical antidepressant in some countries and is commonly prescribed for oral intake at 12.5 mg thrice daily. However, because higher doses can produce euphoria, its use has been restricted and a warning has been added to its drug label about possible addiction. Tianeptine has not been approved by the FDA for any medical use in the United States, is not scheduled under its Controlled Substances Act, is not considered to be safe in food, and has not met regulations as a dietary ingredient. 'Nevertheless, tianeptine is being marketed as a 'research chemical,' a 'nootropic' cognitive enhancer, or a dietary supplement,' the agency reported. In addition to gas stations, the product — which also goes by names such as Tianaa, Zaza, Neptune's Fix, Pegasus, and TD Red — is often available at convenience stores, vape shops, and online retailers. The FDA noted that unlike the 37.5 mg total daily dose amount recommended by countries that have approved the product, there have been reports of individuals in the United States ingesting doses from 50 mg to 10,000 mg. So far, the agency has sent warning letters to companies that distribute and sell products that contain tianeptine and is taking steps to warn individuals about the drug's potential severe adverse events. In addition, it has issued an import alert to help detain shipment of the products containing the drug at US borders. The FDA recommended that healthcare professionals talk to patients about these products and encourage their avoidance. Tianeptine may not be identified in routine drug-screening panels. Those who believe a patient is experiencing a related adverse event should contact (External Link Disclaimer) and can visit the FDA's MedWatch website to submit a report.
Yahoo
13-05-2025
- Health
- Yahoo
FDA says ‘dangerous' substance known as ‘gas station heroin' poses major risk to young people
The head of the U.S. Food and Drug Administration (FDA) is sounding the alarm on a dangerous drug referred to as "gas station heroin," that can lead to serious harm, including death. FDA Commissioner Martin A. Makary sent a letter to his colleagues last week to draw their attention to what he called a "dangerous and growing health trend" facing the nation and young people. Makary said there is an increasing number of adverse events involving products that contain tianeptine. Tianeptine, often called "gas station heroin," is sold in gas stations through a variety of products, despite the drug not being approved by the FDA. "I am very concerned," Makary wrote. "I want the public to be especially aware of this dangerous product and the serious and continuing risk it poses to America's youth." 'Gas Station Heroin' Is Growing Threat In New Jersey, Health Officials Warn: 'Dangerous And Addictive' The products are typically sold at convenience stores, gas stations, vape shops and online retailers, and go by names like Tianaa, ZaZa, Neptune's Fix, Pegasus and TD Red. Read On The Fox News App Makary said the FDA is following the distribution and sale of products that contain tianeptine but called on his colleagues to disseminate information about the drug while appreciating the magnitude of its underlying danger. Tianeptine is licensed and marketed in some countries as an atypical antidepressant, and in countries where it is approved, the typical labeled dose to treat depression is 12.5 mg orally, three times per day, Makary said. When higher doses are taken, they can produce euphoria. Some countries have taken steps to restrict how tianeptine is prescribed or dispensed and have even revised the labels to warn people of its potential addiction. Teen Drug Overdoses Hit Record High, Driven Primarily By Fentanyl Poisoning, Says New Report In the U.S., though, tianeptine is not listed as part of the Controlled Substances Act. The drug is often taken recreationally, though if stopped abruptly, users could experience withdrawal symptoms similar to those associated with opioid withdrawal – craving, sweating, diarrhea and more. If tianeptine is ingested, Makary wrote, adverse events could include agitation, coma, confusion, death, drowsiness, hypertension, nausea, respiratory depression, sweating, tachycardia and vomiting. Two years ago, New Jersey health officials warned that two products sold as dietary supplements in gas stations and online – Neptune's Elixir and ZaZa Red – had caused a spike in illnesses. What Is Ketamine, The Drug That Killed Matthew Perry On October 28? Between June and November 2023, there were 20 reported cases of tianeptine causing "severe clinical effects" in New Jersey, as noted in a Feb. 1 alert from the U.S. Centers for Disease Control and Prevention (CDC). In 2023, the FDA posted an alert warning of the dangers of Neptune's Fix or any other product containing tianeptine. "FDA has received severe adverse event reports after use of Neptune's Fix products, including seizures and loss of consciousness leading to hospitalization," the agency stated. "FDA considers tianeptine to be a substance that does not meet the statutory definition of a dietary ingredient and is an unsafe food additive. The FDA is aware of several serious adverse event reports associated with tianeptine." On Jan. 28, 2024, Neptune Resources, LLC, the maker of Neptune's Fix, issued a voluntary recall of its products due to the presence of tianeptine — but experts are warning that other products may also contain the drug. Anyone who is using tianeptine or a product containing tianeptine and is experiencing withdrawal symptoms can call the National Poison Control Center at 1-800-222-1222 or seek emergency medical assistance, experts advised. Fox News Digital's Melissa Rudy contributed to this article source: FDA says 'dangerous' substance known as 'gas station heroin' poses major risk to young people
USA Today
09-05-2025
- Health
- USA Today
FDA issues warning against tianeptine use, also called 'gas station heroin'
FDA issues warning against tianeptine use, also called 'gas station heroin' Show Caption Hide Caption FDA will reduce food and drug inspections due to federal layoffs FDA scales back routine inspections due to support staff layoffs, prioritizing high-risk cases amid government restructuring and budget cuts. Straight Arrow News This article discusses suicidal ideation. If you or someone you know is struggling or in crisis, help is available. Call or text 988 or chat at The U.S. Food and Drug Administration is warning the public about a drug rising in popularity, commonly referred to as "gas station heroin." Tianeptine poses a "dangerous and growing health trend" across the U.S., particularly putting young people at risk, Food and Drugs Commissioner Dr. Marty Makary said in a May 8 news release. No use of the drug has received FDA approval as it can result in serious harm or death, Makary clarified. He emphasized the public must address the trend before it becomes the latest example of delayed recognition patterns previously seen in opioid abuse and youth vaping. "I am very concerned. I want the public to be especially aware of this dangerous product and the serious and continuing risk it poses to America's youth," Makary said. "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." Here's what to know about tianeptine. Is tianeptine banned in the U.S.? Tianeptine has been banned in 10 U.S. states: Alabama Florida Georgia Indiana Kentucky Michigan Mississippi Ohio Tennessee North Carolina What products is tianeptine sold as? Makary said tianeptine is sold under various product names, including Tianaa, Zaza, Neptune's Fix, Pegasus and TD Red. Is tianeptine legal in other countries? Tianeptine is licensed in some countries and marketed as an atypical antidepressant meant to treat depression through three daily 12.5 mg oral doses, according to Makary. "Higher doses can produce euphoria, and some countries have restricted how tianeptine is prescribed and dispensed or revised the drug label to warn of possible addiction," Makary said. "FDA recommends that health care professionals encourage patients to avoid all products containing tianeptine, including those claiming to treat an ailment or disorder." What is tianeptine? Tianeptine is prescribed as an antidepressant in some European, Asian and Latin American countries, but it's not approved for any medical use in the U.S. Still, companies are marketing and selling tianeptine products as dietary supplements typically in pill and powder form, claiming it can improve brain function and treat depression, anxiety, pain and even opioid use disorder. The drug is typically available gas stations, convenience stores, vape shops and online retailers, according to the FDA. While many use tianeptine to treat their ailments and assume they are safe because of their availability. However, the FDA said tianeptine is a prime example of availability not indicating effectiveness or safety. Tianeptine has been banned in Alabama, Florida, Georgia, Indiana, Kentucky, Michigan, Mississippi, Ohio and Tennessee. Can people get addicted to tianeptine? According to the Cleveland Clinic, tianeptine is addictive. In an April 2024 interview with USA TODAY, Alabama woman Chrissy Reifschneider said she tried tianeptine pills after a family member who worked at a gas station recommended them to her. Within days, she said she became addicted to the drug, and experienced three gruesome years. Reifschneider said she took about five pills every four hours in which she experienced hair loss, weight loss, auditory hallucinations; developed paranoia surrounding electronics and suicidal ideations. "I thought well, I'm not sticking a needle in my arm, so I literally convinced myself that I wasn't a drug addict until I realized I didn't recognize who I was anymore," Reifschneider, who is now sober, told USA TODAY last year. "It's crazy to think that these gas station pills just controlled me. I was ashamed because I'd rather people know I was shooting up heroin than actually spending all this time and money on over-the-counter (drugs)." What are the risks of using tianeptine? The FDA lists the following adverse events reported in people who ingested tianeptine. Agitation Confusion Drowsiness Nausea Sweating Vomiting Tachycardia Hypertension Respiratory depression Coma Death The FDA also said some symptoms of tianeptine withdrawal are similar to opioid discontinuation, including: Craving Sweating Goose flesh or goosebumps Diarrhea Muscle aches and pain Contributing: Katie Camero
Yahoo
09-05-2025
- Health
- Yahoo
FDA issues warning against tianeptine use, also called 'gas station heroin'
This article discusses suicidal ideation. If you or someone you know is struggling or in crisis, help is available. Call or text 988 or chat at The U.S. Food and Drug Administration is warning the public about a drug rising in popularity, commonly referred to as "gas station heroin." Tianeptine poses a "dangerous and growing health trend" across the U.S., particularly putting young people at risk, Food and Drugs Commissioner Dr. Marty Makary said in a May 8 news release. No use of the drug has received FDA approval as it can result in serious harm or death, Makary clarified. He emphasized the public must address the trend before it becomes the latest example of delayed recognition patterns previously seen in opioid abuse and youth vaping. "I am very concerned. I want the public to be especially aware of this dangerous product and the serious and continuing risk it poses to America's youth," Makary said. "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." Here's what to know about tianeptine. Tianeptine has been banned in 10 U.S. states: Alabama Florida Georgia Indiana Kentucky Michigan Mississippi Ohio Tennessee North Carolina Makary said tianeptine is sold under various product names, including Tianaa, Zaza, Neptune's Fix, Pegasus and TD Red. Tianeptine is licensed in some countries and marketed as an atypical antidepressant meant to treat depression through three daily 12.5 mg oral doses, according to Makary. "Higher doses can produce euphoria, and some countries have restricted how tianeptine is prescribed and dispensed or revised the drug label to warn of possible addiction," Makary said. "FDA recommends that health care professionals encourage patients to avoid all products containing tianeptine, including those claiming to treat an ailment or disorder." Tianeptine is prescribed as an antidepressant in some European, Asian and Latin American countries, but it's not approved for any medical use in the U.S. Still, companies are marketing and selling tianeptine products as dietary supplements typically in pill and powder form, claiming it can improve brain function and treat depression, anxiety, pain and even opioid use disorder. The drug is typically available gas stations, convenience stores, vape shops and online retailers, according to the FDA. While many use tianeptine to treat their ailments and assume they are safe because of their availability. However, the FDA said tianeptine is a prime example of availability not indicating effectiveness or safety. Tianeptine has been banned in Alabama, Florida, Georgia, Indiana, Kentucky, Michigan, Mississippi, Ohio and Tennessee. According to the Cleveland Clinic, tianeptine is addictive. In an April 2024 interview with USA TODAY, Alabama woman Chrissy Reifschneider said she tried tianeptine pills after a family member who worked at a gas station recommended them to her. Within days, she said she became addicted to the drug, and experienced three gruesome years. Reifschneider said she took about five pills every four hours in which she experienced hair loss, weight loss, auditory hallucinations; developed paranoia surrounding electronics and suicidal ideations. "I thought well, I'm not sticking a needle in my arm, so I literally convinced myself that I wasn't a drug addict until I realized I didn't recognize who I was anymore," Reifschneider, who is now sober, told USA TODAY last year. "It's crazy to think that these gas station pills just controlled me. I was ashamed because I'd rather people know I was shooting up heroin than actually spending all this time and money on over-the-counter (drugs)." The FDA lists the following adverse events reported in people who ingested tianeptine. Agitation Confusion Drowsiness Nausea Sweating Vomiting Tachycardia Hypertension Respiratory depression Coma Death The FDA also said some symptoms of tianeptine withdrawal are similar to opioid discontinuation, including: Craving Sweating Goose flesh or goosebumps Diarrhea Muscle aches and pain Contributing: Katie Camero This article originally appeared on USA TODAY: Gas station heroin: FDA warns public of tianeptine use
Epoch Times
08-05-2025
- Health
- Epoch Times
FDA Warns of Growing Threat From ‘Gas Station Heroin' Sold as Supplements
Federal health officials are warning about a surge in reports of serious health issues tied to tianeptine, a drug being sold as a supplement despite not being approved for any medical use in the United States. Commonly referred to as 'gas station heroin' due to its availability at convenience stores, gas stations, and online retailers, tianeptine has been associated with overdoses, withdrawal symptoms, and at least one cluster of deaths. The Food and Drug Administration (FDA) issued a renewed alert this week, urging the public and health care providers to avoid products that contain the substance. 'I am writing to draw your attention to a dangerous and growing health trend facing our nation and particularly young people—the increasing number of adverse events involving products containing tianeptine, which can lead to serious harm, including death,' FDA Commissioner Dr. Martin Makary said in a May 8 The FDA stressed that many consumers mistakenly The drug is prescribed as an antidepressant in some countries, though it is not approved in the United States and is not scheduled under the Controlled Substances Act. The FDA notes that it is being illegally sold as a dietary supplement or 'nootropic,' with product names that include Tianaa, Zaza, Neptune's Fix, Pegasus, and TD Red. Some vendors are also making unproven and illegal claims that tianeptine can improve brain function or treat anxiety, depression, pain, and opioid use disorder, according to the agency. Related Stories 4/23/2025 4/22/2025 Ingesting tianeptine can lead to severe health effects, including respiratory depression, coma, and death. Withdrawal symptoms similar to those caused by opioids have also been reported. Medical literature cites instances of users taking doses of up to 10,000 milligrams per day—hundreds of times greater than the level it is prescribed at in other countries. The FDA noted that individuals with a history of opioid dependence may be particularly vulnerable to abusing tianeptine, sometimes using it as an opioid substitute or for self-treatment of mental health conditions. A 2024 outbreak in New Jersey linked to a product called 'Neptune's Fix' highlighted the drug's dangers. The product was found to contain both tianeptine and synthetic cannabinoid receptor agonists, the agency said. Reported side effects included seizures, cardiac irregularities, and fatalities. 'Historically, there has been a delayed recognition of fast-growing trends, such as opioid abuse and vaping addiction in youth,' Makary said in the statement. 'Let's be proactive in understanding and addressing the use of tianeptine products, which are available even to our nation's youth.' The FDA has taken some enforcement actions, including issuing warning letters and placing imports of tianeptine-containing products on alert to prevent them from entering the country. Still, the agency noted that the products continue to be sold without regulation. The agency also classified tianeptine as an unsafe food additive and stated it does not meet the legal definition of a dietary ingredient, underscoring that such products cannot be lawfully marketed as supplements. Health care professionals are being advised to counsel patients on avoiding tianeptine and to consider alternative, evidence-based treatments for conditions such as depression, anxiety, or opioid use disorder. In cases of suspected tianeptine poisoning, medical professionals should contact the Poison Help Line and report incidents to the FDA's MedWatch portal. The FDA emphasized that routine drug screening panels may not detect tianeptine, complicating diagnosis in emergency settings. Consumers and medical professionals can report adverse effects or suspicious products through the FDA's website or by calling 1-888-INFO-FDA. Individuals struggling with substance use or addiction can call 1-800-662-HELP or visit for support and treatment resources.
