FDA issues warning against tianeptine use, also called 'gas station heroin'
FDA issues warning against tianeptine use, also called 'gas station heroin'
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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.
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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
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