A bipartisan group of lawmakers are calling for the Food and Drug Administration to take “immediate action” on tianeptine, an unapproved drug nicknamed “gas station heroin” because of its opioid-like effects.
Five members of Congress, led by Reps. Jeff Jackson, a Democrat, and Rich McCormick, a Republican, wrote a letter to the FDA expressing concern about tianeptine, which is not a federally-scheduled drug and is sold at gas stations, smoke shops, and convenient stores around the country, often illegally marketed as a dietary supplement. The letter cited VICE News’ reporting and noted that tianeptine can cause symptoms that mimic opioid withdrawal, including nausea, chills, insomnia, restless legs, and extreme anxiety.
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Several states, including Florida, Arkansas, Kentucky, Michigan, Alabama, Minnesota, Tennessee, Georgia, Ohio, Oklahoma, Mississippi, and Indiana have banned the drug, which is commonly sold under brand names like Pegasus, Zaza, and Tianaa.
Tianeptine is tricyclic antidepressant that hits the opioid receptors; it is regulated and used as an antidepressant in dozens of countries but is unregulated in the U.S. Tianeptine has been linked to at least a handful of deaths in the U.S. and has been subject to multiple FDA warnings. A warning from November said that people were having seizures and being hospitalized after drinking shots of Neptune’s Fix, a liquid form of tianeptine.
“We urge the FDA to take immediate action to research and provide guidance on tianeptine use,” says the letter from members of Congress, which was also signed by Reps. John Rose and Lauren Boebert, Republicans, and Wiley Nickel, a Democrat.
“While we appreciate these warnings, we believe that more action on tianeptine use is needed to ensure the health and well-being of the American people.”
The letter asked the FDA to respond to a number of questions including: what action it has take to provide oversight of tianeptine, besides the warnings; what research the agency is doing to determine its pharmacological properties; how its working with federal and state law enforcement and public health agencies to better understand the marketing and distributing of the drug; and if the FDA has worked with the DEA to research whether tianeptine should be scheduled by the Controlled Substances Act.
VICE News has reached out to the FDA for a response to the letter and was told “the FDA has received the letter and will respond directly to the member(s) of Congress.”
The FDA previously declined a VICE News interview request about tianeptine, which VICE News has been reporting on for over a year.
At the time, the FDA said tianeptine “is not approved by the FDA for any medical use, and it has not been reviewed by the FDA for safety, effectiveness, or quality.”