In March, the U.S. Senate confirmed Dr. Martin Makary, as the new commissioner of the Food and Drug Administration (FDA).
On April 1, Makary, a pancreatic surgeon and former health policy researcher and professor, at Johns Hopkins University, was sworn into the position.
Makary, whose nickname is Marty, sent a letter Thursday to colleagues warning them about "gas station heroin."
He wrote:
I am writing to draw your attention to a dangerous and growing health trend facing our nation and particularly young people– the increasing number of adverse events involving products containing tianeptine, which can lead to serious harm, including death. Tianeptine, which is often called “gas station heroin” because of its availability in gas station stores, is not approved by the FDA for any use.
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. 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.
What is gas station heroin?
According to Makary's letter, tianeptine is not approved by the FDA for "any medical use" in the United States. But it's also not currently scheduled under the Controlled Substances Act. That creates a grey area.
In European, Asian and South American countries, tianeptine is a medicine available to treat anxiety, depression and irritable bowel syndrome.
Additionally, tianeptine is not approved by the FDA for any medical use. It is "not generally recognized as safe for use in food, and does not meet the statutory definition of a dietary ingredient," Makary wrote.
Yet, it can be bought in gas stations and vape stores and online in the United States. Product names include Tianaa, Zaza, Neptune’s Fix, Pegasus, and TD Red.
The FDA states, "People seeking to treat their ailments may sometimes mistake a product as being safe because it’s easily available. But availability is no indication of effectiveness or safety. This is especially true of tianeptine."
Tianeptine is marketed for weight loss and to ease symptoms of depression, anxiety, pain and other ailments. Users need to talk to their doctors if they are using it.
Tianeptine has many adverse events:
- agitation
- coma
- confusion
- death
- drowsiness
- hypertension
- nausea
- respiratory depression
- sweating
- tachycardia
- vomiting
Tianeptine may not be identified in routine drug screening panels if an overdose occurs.
Withdrawing from the drug is hard, experts say, with many symptoms.
The 1980s
Tianeptine began as an antidepressant in France, according to the Pharmaceutical Manufacturing Encyclopedia.
In 2012, France's Transparency Committee even stated it wasn't sure how the drug worked as an antidepressant. "Tianeptine is an antidepressant, the exact mechanism of action of which is not known," the committee noted.
U.S. officials are watching tianeptine closely.
The crack down
Last July North Carolina made tianeptine illegal. So have many other states including Arkansas in 2022.
In February 2024, Arkansas Attorney General Tim Griffin posted on X: "Tianeptine, commonly known as “gas station heroin,” is on the rise in many parts of the country. In Arkansas, selling or possessing tianeptine is a felony. If you have information about this drug being sold or possessed in Arkansas, please contact my office at (800) 482-8982 or oag@arkansasag.gov."
Still, use of the drug is a continuing problem.
In December, Immigration and Customs Enforcement (ICE) stated in a news release that 22 pounds of gas station heroin – also known as tianeptine – was intercepted at an international express consignment facility in New Jersey.
Two weeks ago, Louisiana TV station KLFY reported that in Pineville, La., Troy Reese was arrested after "a multi-agency drug enforcement operation uncovered hundreds of illegal products, including suspected THC vapes and a dangerous substance known as 'Gas Station Heroin,' at a local vape shop."
With the drug having opioid- and stimulant-like effects, tianeptine will continue to be a problem.
In his letter Thursday Makary wrote, "FDA has taken steps to protect people from tianeptine products, including warning consumers about severe side effects, issuing warning letters to companies distributing and selling unlawful tianeptine products, and placing products on import alert to help detain tianeptine shipments at our borders."
As overdoses continue, however, Makary urges, "As appropriate, health care professionals could also consider talking with patients about evidence-based treatment options for opioid use disorder, depression, anxiety, or pain, and about how to access overdose reversal medicines, including over-the-counter naloxone nasal spray."
