Tianeptine sales spur another FDA warning, action by state lawmakers

The rising wave of tianeptine exposures has prompted the Food and Drug Administration to issue another warning about the substance described as “gas station heroin,” as well as publicize a jail term handed down to a seller of the illegal drug.

Last week, FDA issued a warning about products sold by Super Chill Products under the brand name Neptune’s Fix. The agency had previously warned about products sold under this name and said this new set of products might have slightly different branding than those it has cited in the past.

According to the warning, FDA said it “continues to receive severe adverse event reports after use of Neptune’s Fix products, including seizures, loss of consciousness and death.”

“These products may also interact, in life-threatening ways, with other medications a consumer may be taking. The agency is actively investigating adverse event reports in conjunction with local and state health departments,” FDA added.

Jail sentence handed down in tianeptine case

In addition to the warning, the agency announced a sentencing in a successful prosecution over sale of the banned ingredient. 

Ryan M. Stabile, 37, of Pasadena, Calif., was sentenced by a U.S. District Court judge in Boston to two years in prison as well as three years of probation. He also was ordered to pay a forfeiture of $1.8 million. Stabile had pleaded guilty in September 2023 to one count of conspiracy and two counts of introduction of misbranded drugs with intent to defraud and mislead.

Related:Tianeptine, aka ‘gas station heroin,’ leads to congressional letter to FDA

“Mr. Stabile knew how addicting and dangerous tianeptine was and yet it did not stop him from smuggling the illegal drug into the United States and selling it under false pretenses,” said Acting United States Attorney Joshua S. Levy. “He continued to profit off the addiction of others even after he was indicted.”

Stabile’s lawyers argued he had proactively addressed his drug addiction during the 11 months he had already served before his sentencing trial. They requested he be sentenced to time served, along with three years of probation. The prosecutors had asked the judge to impose a sentence of four years in prison, followed by probation.

Stabile’s lawyers did not immediately respond to a request for additional comment.

Stabile marketed his products via his business named Supplements for Work. Despite the name, Stabile marketed the products using the catchphrase “for research purposes only,” which is an increasingly common dodge used by marketers of banned ingredients or novel substances that have not gone through the new dietary ingredient notification process required under the Dietary Supplement Health and Education Act of 1994 (DSHEA).

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Stabile marketed tianeptine as a mood enhancer and claimed it could improve cognitive functioning.

North Carolina considers tianeptine restrictions

Action on the federal level has spurred some state lawmakers to act, too. On Sunday, Feb. 19, it was reported by the site North Carolina Health News that lawmakers in that state are considering ways to more tightly regulate the product.

During a hearing of the state’s House Select Committee on Drug Abuse, Penny Shelton, head of the N.C. Association of Pharmacists, testified, “When tianeptine is taken at high doses, it produces euphoria.”

“Tianeptine in high doses is like any other substance with the potential for misuse and dependence, in that it does far more than create euphoria — or a high. It actually changes neuronal pathways in the brain,” she added. “This is particularly problematic for teens and young adults.”

Tianeptine is sold as an antidepressant drug in some countries, where a typical dose is 12.5 milligrams (mg) a day. Products available on the internet in the U.S. can contain 100 mg per capsule or more.

Poison center data shows increasing exposures

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According to Dr. Kait Brown, PharmD, the clinical managing director of America’s Poison Centers, tianeptine exposures have shown an alarming trend.

The organization’s data from its 55 poison control centers shows that 105 cases involving tianeptine were documented in 2019. That number had risen to 391 in 2023.

“Most cases of tianeptine exposures reported to U.S. Poison Centers involved adults intentionally using the substance to get high. Symptoms reported range from agitation, increased heart rate and confusion to more severe symptoms similar to opioid toxicity including sedation, respiratory depression and slowed heart rate,” Brown said.