
'Gas station heroin' is technically illegal and widely available. Here are the facts
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.
Sometimes called 'gas station heroin,' the products are usually marketed as energy shots or cognitive supplements but actually contain tianeptine, an unapproved drug that can be addictive and carries risks of serious side effects.
U.S. poison control centers have reported a steady rise in calls linked to the drug for more than a decade. And last month the Food and Drug Administration sent a warning to health professionals about 'the magnitude of the underlying danger or these products.'
Here's what to know about gas station heroin.
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.
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.
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.
'It's kind of this grey area of consumer products, or supplements, where the contents are not regulated or tested the way they would be with a medication,' said Dr. Diane Calello of the New Jersey Poison Information and Education System.
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.
Many tianeptine products claim— without evidence or FDA approval— to help users treat medical conditions, including addiction, pain and depression.
In 2018, the FDA issued a warning letter to the maker of a product called Tianna, which claimed to provide 'an unparalleled solution to cravings for opiates.'
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.
'That's what tends to get people into trouble,' said Dr. Hannah Hays of Nationwide Children's Hospital in Columbus, Ohio. 'They use it for opioid-like effects or to self-treat opioid withdrawal and that can lead to slow breathing and problems like that."
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.
Experts aren't sure but national figures show a big rise in emergency calls involving the drug.
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.
One explanation for the rise in calls is simply that more Americans are using the products.
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.
'You never quite know what's in that bottle," Calello said. 'It's important for people to know that even if they have used a product before, they could get a bottle that contains something very different from what they're looking for.'
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.
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.
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.
© Copyright 2025 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed without permission.
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Tokyo Reported
25-06-2025
- Tokyo Reported
Experimental Treatments Continue To Gain Popularity
The landscape of medical treatment is rapidly evolving as experimental therapies gain unprecedented traction among patients, healthcare providers, and regulatory bodies worldwide. This surge in interest reflects both advancing scientific capabilities and growing patient demand for access to cutting-edge treatments that may offer hope where traditional therapies have fallen short. Rising Numbers in Clinical Trial Participation According to GlobalData's Pharmaceutical Intelligence Centre, most trials completed in 2024 were Phase I studies (40.92%), with the second highest completion in Phase II (36.28%). During 2024, 15.62% of trial completions were Phase III studies. In 2024, there were 7,089 completions, demonstrating the robust pipeline of experimental treatments moving through the research and development process. currently lists 455,437 studies with locations in all 50 States and in 221 countries. As of March 2021, receives about 4.5 million visitors monthly, indicating substantial public interest in experimental treatment options. This massive database represents one of the most comprehensive resources for patients seeking information about ongoing clinical trials and experimental therapies. The global reach of experimental treatments has expanded significantly, with most (75%) included both males and females in trial designs, while most (73%) included adults in their inclusion criteria while 12% included children. This broad inclusivity demonstrates the medical community's commitment to developing treatments that can benefit diverse patient populations. Cancer Treatment Leading the Experimental Frontier Cancer research continues to dominate the experimental treatment landscape, with remarkable success rates emerging from recent clinical trials. Patients with cancer commonly participate in many kinds of clinical studies, including 7% in treatment trials, representing hundreds of thousands of individuals who are actively participating in the development of tomorrow's standard treatments. The results from these experimental cancer therapies have been particularly encouraging. Some recent trials have shown success rates exceeding 70 percent in certain patient populations, demonstrating the potential of these innovative approaches to transform cancer care. These promising outcomes have contributed significantly to the growing enthusiasm for experimental treatments among both patients and oncologists. Regulatory Changes and Access Expansion The regulatory environment surrounding experimental treatments has undergone significant changes to accommodate growing demand and evolving scientific understanding. Montana just passed a new bill backed by longevity enthusiasts that will enable access to drugs and therapies that are not approved by the FDA, representing a notable shift in how states are approaching experimental treatment access. This regulatory evolution reflects broader trends in healthcare policy that prioritize patient autonomy and expanded access to potentially life-saving treatments. The movement toward more flexible regulatory frameworks has been driven by patient advocacy groups, healthcare providers, and researchers who argue that traditional approval timelines may be too restrictive for patients facing serious medical conditions. Post Trial Access Challenges and Solutions One of the most significant developments in experimental treatment policy involves post-trial access for patients who have participated in clinical studies. Post-Trial, Continued Access can be defined as the continued provision of the investigational medicine or continued maintenance of the investigational significant risk device for any clinical trial participant after participation in the trial. This concept has become increasingly important as more patients participate in experimental treatments and require ongoing access to therapies that may not yet be commercially available. Post-trial, continued access is a shared responsibility and should be determined before the trial begins, highlighting the need for comprehensive planning and coordination among sponsors, researchers, healthcare systems, and regulatory bodies. This approach ensures that patients who have contributed to medical research by participating in experimental treatments are not left without access to potentially beneficial therapies once formal trials conclude. 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These digital health solutions represent a new frontier in experimental treatments, offering patients access to innovative therapies that can be delivered remotely and monitored in real-time. The integration of artificial intelligence, machine learning, and advanced data analytics has enabled researchers to develop more personalized experimental treatments and improve patient outcomes. Economic Impact and Market Growth The economic implications of the growing experimental treatment sector are substantial. Breakthrough therapies launched over the past decade for multiple diseases are re-shaping patient care in many areas and the outlook for medicines use – and the related Spending – through 2028 is higher than prior forecasts as more novel drugs become available. This economic growth reflects not only increased investment in research and development but also growing patient willingness to pursue experimental treatment options. The expansion of insurance coverage for experimental treatments and the development of patient assistance programs have made these therapies more accessible to broader patient populations. Future Outlook and Implications The continued growth in experimental treatment popularity represents a fundamental shift in healthcare delivery and patient expectations. About 80% of clinical trials experience delays or are prematurely terminated due to challenges in recruiting participants, yet increasing patient interest in experimental treatments may help address these recruitment challenges and accelerate the development of new therapies. As experimental treatments continue to gain popularity, healthcare systems must adapt to support increased demand while maintaining safety standards and ethical oversight. The success of these efforts will ultimately determine how quickly promising experimental treatments can be translated into standard care options that benefit patients worldwide. 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Japan Today
20-06-2025
- Japan Today
'Gas station heroin' is technically illegal and widely available. Here are the facts
By MATTHEW PERRONE 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. Sometimes called 'gas station heroin,' the products are usually marketed as energy shots or cognitive supplements but actually contain tianeptine, an unapproved drug that can be addictive and carries risks of serious side effects. U.S. poison control centers have reported a steady rise in calls linked to the drug for more than a decade. And last month the Food and Drug Administration sent a warning to health professionals about 'the magnitude of the underlying danger or these products.' Here's what to know about gas station heroin. 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. 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. 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. 'It's kind of this grey area of consumer products, or supplements, where the contents are not regulated or tested the way they would be with a medication,' said Dr. Diane Calello of the New Jersey Poison Information and Education System. 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. Many tianeptine products claim— without evidence or FDA approval— to help users treat medical conditions, including addiction, pain and depression. In 2018, the FDA issued a warning letter to the maker of a product called Tianna, which claimed to provide 'an unparalleled solution to cravings for opiates.' 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. 'That's what tends to get people into trouble,' said Dr. Hannah Hays of Nationwide Children's Hospital in Columbus, Ohio. 'They use it for opioid-like effects or to self-treat opioid withdrawal and that can lead to slow breathing and problems like that." 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. Experts aren't sure but national figures show a big rise in emergency calls involving the drug. 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. One explanation for the rise in calls is simply that more Americans are using the products. 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. 'You never quite know what's in that bottle," Calello said. 'It's important for people to know that even if they have used a product before, they could get a bottle that contains something very different from what they're looking for.' 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. 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. 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. © Copyright 2025 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed without permission.


Japan Today
17-06-2025
- Japan Today
FDA to offer faster drug reviews to companies promoting 'national priorities'
FILE - Food and Drug Administration (FDA) commissioner Marty Makary speaks during a news conference at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. (AP Photo/Jose Luis Magana, file) By MATTHEW PERRONE U.S. regulators will begin offering faster reviews to new medicines that administration officials deem as promoting 'the health interests of Americans,' under a new initiative announced Tuesday. Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months. FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months. Since arriving at the FDA in April, Makary has repeatedly told FDA staff they need to 'challenge assumptions' and rethink procedures. In a medical journal commentary published last week, Makary suggested the agency could conduct 'rapid or instant reviews," pointing to the truncated process used to authorize the first COVID-19 vaccines under Operation Warp Speed. For the new program, the FDA will issue a limited number of 'national priority vouchers' to companies 'aligned with U.S. national priorities,' the agency said in a statement. The special designation will give the selected companies access to extra FDA communications, streamlined staff reviews and the ability to submit much of their product information in advance. Speeding up drug approvals has long been a priority of the pharmaceutical industry, which has successfully lobbied Congress to create a variety of special programs and pathways for faster reviews. Many aspects of the plan announced Tuesday overlap with older programs. But the broad criteria for receiving a voucher will give FDA officials unprecedented discretion in deciding which companies can benefit from the fastest reviews. "The ultimate goal is to bring more cures and meaningful treatments to the American public,' Makary said in a statement. Makary said he will prioritize vouchers for companies pursuing products that address health crises, deliver 'innovative cures' or address other unmet public health needs. An administration official said the program wouldn't change FDA approval standards. 'Without altering how new treatments are evaluated — just when — the FDA's new voucher program is a common sense reform that maintains rigorous clinical standards while streamlining needless bureaucracy," Kush Desai, a White House spokesperson, wrote in an emailed statement Tuesday. Separate from this week's announcement, Makary recently suggested the FDA should be willing to ease its scientific requirements for certain drugs targeting rare conditions. In such cases, the agency could consider waiving its requirement for randomized studies, in which researchers track patients over time to evaluate drug safety and effectiveness. Such trials are generally considered the gold standard of medical research, though the FDA has increasingly been willing to accept smaller, less-definitive studies for rare or life-threatening diseases. In several recent cases, the FDA has faced criticism for approving drugs based on preliminary data that didn't ultimately show benefits for patients. The push to rapidly accelerated drug approvals is the opposite approach that Makary and his boss, Health Secretary Robert F. Kennedy Jr., have taken on vaccines. Promising a 'return to gold-standard science,' Kennedy previously announced that all new vaccines would have to be compared to placebo, or a dummy shot, to win approval. Kennedy and Makary also have announced a stricter policy on seasonal updates to COVID-19 shots, saying they will have to undergo new testing before they can be approved for use in healthy children and most adults. © Copyright 2025 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed without permission.