Latest news with #tianeptine
Fox News
12-05-2025
- Health
- Fox News
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." 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. 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. 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.
Daily Mail
10-05-2025
- Health
- Daily Mail
FDA issues urgent warning over supplement linked to sudden deaths after just three uses
The FDA issued a warning to the public about a deadly drug masquerading as a harmless supplement. Dr Marty Makary, FDA Commissioner, wrote an open letter to fellow public health officials in which he advised them spread the word about 'gas station heroin' – powder, liquid, and tablet forms of the unapproved drug tianeptine. 'I want the public to be especially aware of this dangerous product and the serious and continuing risk it poses to America's youth,' Dr 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.' Tianeptine—an opioid-like drug with a high risk of addiction—is not banned under federal law. Yet deaths have occurred after just a few pills. Despite its risks, it is sold as a 'harmless' dietary supplement in gas stations and online, even though the FDA has repeatedly warned that it doesn't qualify as one. They say it was never legally sold as a supplement before 1994—the key cutoff for approval—making its current sales outright illegal. Still, Dr Makary and the FDA have pledged to crack down on sellers violating the law: '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. 'Let's be proactive in understanding and addressing the use of tianeptine products, which are available even to our nation's youth.' The substance has been on the government's radar for years. New Jersey poison control logs reported by the CDC last year revealed a rise in emergencies linked to the brand Neptune's Fix. Between June–November 2023, 20 emergency calls documented 17 patients (ages 28–69) collapsing in altered mental state's, dangerous high heart rate, seizures, and cardiac arrest. Thirteen victims were admitted to the ICU with seven placed on ventilators—though no deaths were reported. Most had ingested the tianeptine-kavain blend, but 6 mixed it with opioids, benzos, or kratom, amplifying the crisis. Nine were repeat users, indicating high potential for addiction. 'I am very concerned, Makary said. 'I want the public to be especially aware of this dangerous product and the serious and continuing risk it poses to America's youth.' Tianeptine has some devastating side effects. While inducing a state of euphoria, it can bring about seizures, agitation, confusion, sweating, nausea, vomiting, drowsiness, coma, and death. The supplement has been linked to at least four fatal overdoses since first hitting US shelves in the 2010s. Some of the most popular products include Tianaa, Zaza, Neptune's Fix, Pegasus, and TD Red, and can be found in gas stations, vape shops, and online. 'Case reports in the medical literature describe U.S. consumers ingesting daily doses on the order of 1.3 to 250 times (50 mg to 10,000 mg) the daily tianeptine dose typically recommended in labeled foreign drug products,' Dr Makary added. Tianeptine is an approved as an antidepressant in some Latin American, Asian and European countries. The FDA has warned that quitting tianeptine can trigger opioid-like withdrawal symptoms, including crippling cravings, sweating, chills, diarrhea, and agonizing muscle pain.
CBS News
09-05-2025
- Health
- CBS News
FDA issues warning against "gas station heroin" tianeptine
The Food and Drug Administration is warning the public about the harmful effects of products containing tianeptine, also referred to as "gas station heroin" due to its availability in gas station stores. Tianeptine is an opioid alternative prescribed as an antidepressant in some Latin American, Asian and European countries. It is not approved by the FDA for any use in the U.S. and can cause a range of adverse events. "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," the FDA's Commissioner of Food and Drugs Dr. Martin A. Makary said in a letter Thursday. "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." According to the letter, tianeptine can lead to serious harm, including death. Other symptoms include agitation, confusion, sweating, nausea, vomiting, drowsiness and coma. Some product names that include the substance include Tianaa, Zaza, Neptune's Fix, Pegasus and TD Red, the letter said, adding that it is often marketed as a "research chemical," "nootropic" cognitive enhancer or a dietary supplement. "Case reports in the medical literature describe U.S. consumers ingesting daily doses on the order of 1.3 to 250 times (50 mg to 10,000 mg) the daily tianeptine dose typically recommended in labeled foreign drug products," the letter read. This isn't the first time these products have made headlines. In 2023, the FDA warned consumers not to use or purchase any products from Neptune's Fix after receiving multiple reports of severe reactions, including seizures and hospitalizations. In 2024, Neptune's Fix products sold nationwide were recalled because of their use of tianeptine. contributed to this report.
