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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.”
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The “supplement” commonly goes by the brand names ZaZa or Tianna Red. (Dekalb County Sheriff’s Office)
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.
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.
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The FDA is warning about the dangers of tianeptine. (REUTERS/Andrew Kelly/File Photo)
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.
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New Jersey health officials raised concerns in 2023 about Neptune’s Fix Elixir, a product containing tianeptine, after a cluster of illnesses was reported in connection with the product. (FDA’s Office of Regulatory Affairs, Health Fraud Branch)
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 report.
President Trump will sign an executive order on Monday aimed at lowering some drug prices in the United States by aligning them with what other wealthy countries pay, he said on Truth Social on Sunday evening.
The proposal he described, which alone cannot shift federal policy, is what he calls a “most favored nation” pricing model. Mr. Trump did not provide details about which type of insurance the plan would apply to or how many drugs it would target, but he indicated that the United States should pay the lowest price among its peer countries.
“Our Country will finally be treated fairly, and our citizens Healthcare Costs will be reduced by numbers never even thought of before,” he wrote in his social media post.
Any such plan will most likely be subject to challenges in court, and it is not clear whether it will pass legal muster, especially without action by Congress.
In his first term, Mr. Trump tried unsuccessfully to enact a version of this idea for Medicare, the health insurance program that covers 68 million Americans who are over 65 or have disabilities. That plan would have applied only to 50 drugs, administered at clinics and hospitals, that are paid for by Medicare. A federal court blocked it, ruling that the administration had skipped steps in the policymaking process.
The pharmaceutical industry bitterly opposes the idea, which would almost certainly cut into its profits, and has been lobbying against it as discussions of the policy have regained steam in Washington in recent weeks. Companies have warned that such a policy would lead them to spend less on research, depriving patients of new medicines.
“Government price setting in any form is bad for American patients,” Alex Schriver, an official at the drug industry’s main lobbying group, PhRMA, said in a statement. He added, “Policymakers should focus on fixing the flaws in the U.S. system, not importing failed policies from abroad.”
Mr. Trump’s embrace of the idea sets him apart from most Republicans, who have tended to be skeptical of government price setting. Democratic lawmakers have proposed versions of the idea.
Ameet Sarpatwari, an expert in pharmaceutical policy at Harvard Medical School, said that Mr. Trump was tapping into an idea that had “populist appeal.”
Mr. Trump has long complained that the United States pays much more than other wealthy countries do for the same drugs. And he is right. In the United States, prices for brand-name drugs are three times as high, on average, as those in peer nations.
That is in spite of the fact that much of the research that leads to new drugs takes place in American laboratories and hospitals.
Drugmakers generate a substantial majority of their worldwide profits from sales in the United States and typically design their business strategy around the U.S. market.
Pharmaceutical companies argue that the higher prices in the United States come with an added benefit: Industry-funded analyses have found that patients in the United States get medicines faster, and with fewer insurance restrictions, than those in other countries.
A simple selfie could hold hidden clues to one’s biological age — and even how long they’ll live.
That’s according to researchers from Mass General Brigham, who developed a deep-learning algorithm called FaceAge.
Using a photo of someone’s face, the artificial intelligence tool generates predictions of the subject’s biological age, which is the rate at which they are aging as opposed to their chronological age.
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FaceAge also predicts survival outcomes for people with cancer, according to a press release from MGB.
A simple selfie could hold hidden clues to one’s biological age — and even how long they’ll live. (iStock)
The AI tool was trained on 58,851 photos of “presumed healthy individuals from public datasets,” the release stated.
To test the tool’s accuracy, the researchers used it to analyze photos of 6,196 cancer patients taken before radiotherapy treatment.
Among the people with cancer, the tool generated a higher biological age that was about five years higher than their chronological age.
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The researchers also tested the tool’s ability to predict the life expectancy of 100 people receiving palliative care based on their photos, then compared it to 10 clinicians’ predictions. FaceAge was found to be more accurate than the clinicians’ predictions.
The researchers’ findings were published in The Lancet Digital Health.
Mass General Brigham developed a deep-learning algorithm called FaceAge, which generates predictions of the subject’s biological age from a photo. (Mass General Brigham)
“We can use artificial intelligence to estimate a person’s biological age from face pictures, and our study shows that information can be clinically meaningful,” said co-senior and corresponding author Hugo Aerts, PhD, director of the Artificial Intelligence in Medicine (AIM) program at Mass General Brigham, in the release.
“This work demonstrates that a photo like a simple selfie contains important information that could help to inform clinical decision-making and care plans for patients and clinicians,” he went on.
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“How old someone looks compared to their chronological age really matters — individuals with FaceAges that are younger than their chronological ages do significantly better after cancer therapy.”
The goal is for the tool to help eliminate any bias that may influence a doctor’s care decisions based on the perception of a patient’s appearance and age.
“While FaceAge may outperform clinicians in some survival predictions, it should augment human judgment, not override it.”
The researchers noted that more research is needed before the tool could be rolled out for clinical use.
Future studies will include different hospitals and cancer patients at various stages of the disease, according to the release. Researchers will also evaluate FaceAge’s ability to predict diseases, general health status and lifespan.
To test the tool’s accuracy, the researchers used it to analyze photos of 6,196 cancer patients taken before radiotherapy treatment. (iStock)
“This opens the door to a whole new realm of biomarker discovery from photographs, and its potential goes far beyond cancer care or predicting age,” said co-senior author Ray Mak, MD, a faculty member in the AIM program at Mass General Brigham, in the release.
“As we increasingly think of different chronic diseases as diseases of aging, it becomes even more important to be able to accurately predict an individual’s aging trajectory. I hope we can ultimately use this technology as an early detection system in a variety of applications, within a strong regulatory and ethical framework, to help save lives.”
ER physician on AI
Dr. Harvey Castro, a board-certified emergency medicine physician and national speaker on artificial intelligence based in Dallas, Texas, was not involved in FaceAge’s development but shared his comments on the tool.
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“As an emergency physician and AI futurist, I see both the promise and peril of AI tools like FaceAge,” he told Fox News Digital.
“What excites me is that FaceAge structures the clinical instinct we call the ‘eyeball test’ — a gut sense of how sick someone looks. Now, machine learning can quantify that assessment with surprising accuracy.”
Among the people with cancer, the tool generated a higher biological age that was about five years higher than their chronological age. (iStock)
Castro predicts that FaceAge could help doctors better personalize treatment plans or prioritize palliative care in oncology — “where resilience matters more than a birthdate.”
The doctor emphasized, however, that caution is key.
“AI models are only as good as the data they’re trained on,” Castro noted. “If the training data lacks diversity, we risk producing biased results.”
“While FaceAge may outperform clinicians in some survival predictions, it should augment human judgment, not override it.”
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Castro also cautioned about potential ethical concerns.
“Who owns the facial data? How is it stored? Do patients understand what’s being analyzed? These questions matter as much as the technology itself,” he said.
“AI can enhance our care — but it cannot replace the empathy, context and humanity that define medicine.” (iStock)
There is also a psychological impact of the tool, Castro noted.
“Being told you ‘look older’ than your age could influence treatment decisions or self-perception in ways we don’t yet fully understand,” he said.
“We need clear consent, data privacy and sensitivity. No one wants to be told they look older without context.”
For more Health articles, visit www.foxnews.com/health
The bottom line, according to Castro, is that AI can enhance a doctor’s judgment, but cannot replace it.
“AI can enhance our care — but it cannot replace the empathy, context and humanity that define medicine.”
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