The U.S. Food and Drug Administration has issued an urgent public health warning against tianeptine, a substance commonly referred to as "gas station heroin," citing its potential to cause serious harm or death. FDA Commissioner Dr. Marty Makary emphasized the substance poses a "dangerous and growing health trend" across the United States, with young people particularly at risk.
"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 stated in a May 8 news release. "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."
Widespread Availability Despite State Bans
Despite not being approved for any medical use in the United States, tianeptine products are widely available at gas stations, convenience stores, vape shops, and online retailers. The substance is typically sold under various brand names including Tianaa, Zaza, Neptune's Fix, Pegasus, and TD Red.
Currently, ten states have banned tianeptine: Alabama, Florida, Georgia, Indiana, Kentucky, Michigan, Mississippi, Ohio, Tennessee, and North Carolina. However, the FDA warns that accessibility should not be confused with safety or effectiveness.
Medical Uses Abroad vs. U.S. Status
Tianeptine is licensed in some European, Asian, and Latin American countries as an atypical antidepressant, typically prescribed in three daily 12.5 mg oral doses. Some countries have restricted how tianeptine is prescribed and dispensed or revised drug labels to warn of possible addiction.
In the U.S., companies market tianeptine products as dietary supplements in pill and powder form, making unsubstantiated claims that they can improve brain function and treat depression, anxiety, pain, and even opioid use disorder.
Severe Health Risks and Addiction Potential
The FDA has documented numerous adverse events associated with tianeptine use, including:
- Agitation and confusion
- Drowsiness and nausea
- Sweating and vomiting
- Tachycardia and hypertension
- Respiratory depression
- Coma
- Death
According to the Cleveland Clinic, tianeptine is highly addictive. The FDA notes that withdrawal symptoms mirror those of opioid discontinuation, including intense cravings, sweating, goose flesh, diarrhea, and muscle aches and pain.
Personal Account of Addiction
Alabama resident Chrissy Reifschneider shared her harrowing experience with tianeptine addiction in an April 2024 interview with USA TODAY. After trying tianeptine pills recommended by a family member who worked at a gas station, she became addicted within days.
"I took about five pills every four hours," Reifschneider recounted. During her three-year addiction, she experienced hair loss, weight loss, auditory hallucinations, 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," said Reifschneider, who is now sober. "It's crazy to think that these gas station pills just controlled me."
FDA Taking Action
The FDA has taken regulatory steps by sending warning letters to companies selling tianeptine products. The agency strongly advises healthcare professionals to encourage patients to avoid all products containing tianeptine, including those claiming to treat ailments or disorders.
Commissioner Makary emphasized the need for proactive public awareness, noting concerns that tianeptine could become the latest example of delayed recognition patterns previously seen in opioid abuse and youth vaping if not addressed promptly.
Healthcare providers are urged to report adverse events related to tianeptine to the FDA's MedWatch program, while consumers should avoid all products containing this unapproved substance.
