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.
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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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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.
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