FDA urges consumers not to buy tianeptine products due to serious risks as lawmakers call for ‘immediate action’

(CNN) — The US Food and Drug Administration is warning consumers not to purchase or use any tianeptine products, saying it continues to receive reports of severe adverse events, including death, linked to the substance.

Some lawmakers have urged FDA Commissioner Dr. Robert Califf to take immediate action on the use of tianeptine products, citing the need for more research on its effects.

The antidepressant is prescribed in Europe, Asia and Latin America to treat major depressive disorder, according to the FDA. However, it is not approved for use in the US, and tianeptine products are often sold illegally online and at gas stations, vape shops and smoke shops.

In the US, tianeptine products are often marketed as dietary supplements that can improve brain function and treat conditions including anxiety, depression, pain and opioid use disorder, the FDA says.

Some people use tianeptine as an opioid alternative or to self-treat anxiety or depression, according to the FDA. Side effects may include agitation, drowsiness, confusion, sweating, rapid heartbeat, high blood pressure, nausea, vomiting, slowed or stopped breathing, coma and death.

The agency issued a warning about tianeptine products – including those sold under the name Neptune’s Fix – in November. In an update posted Tuesday, the FDA told consumers not to use or purchase any tianeptine products and said the use of these products under the Neptune’s Fix name has been linked to “severe adverse event reports” including seizures, loss of consciousness and death.

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

“Neptune Resources, LLC has agreed to voluntarily recall all lots of Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir and Neptune’s Fix Tablets to the consumer level,” the agency says. It sent a letter to convenience stores, gas stations and other organizations in January to advise them to stop selling products containing tianeptine.

Neptune Resources has not responded to a request for comment regarding its products.

In a letter to the FDA on Thursday, Reps. Jeff Jackson, D-North Carolina, and Rich McCormick, R-Georgia, asked the FDA whether it is working with the Drug Enforcement Administration on possibly adding tianeptine to a drug schedule under the Controlled Substances Act.

“The urgent need for FDA action on tianeptine cannot be overstated,” the letter says. “It is vital to support legislative or administrative initiatives that strengthen FDA oversight and provide states greater ability to protect our communities from the dangers posed by substances like tianeptine.”

Between January 1, 2019, and December 31, 2023, about 1,100 “human exposures” involving tianeptine were reported to US poison centers, Maggie Maloney, a spokesperson for America’s Poison Centers, said in a statement Wednesday. Nearly 400 exposures were reported in 2023, with the number of cases increasing each year since 2019.

“Most cases of tianeptine exposures reported to U.S. Poison Centers involved adults intentionally using the substance to get high,” she said.

In recent years, at least two deaths related tianeptine products marketed as dietary supplements have been reported to the FDA, according to data from the agency’s Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System, which receives and monitors reports of adverse events or product complaints for foods, dietary supplements or cosmetics.

The agency began receiving adverse event reports related to tianeptine products in 2015. Since then, consumers have reported 35 adverse events involving tianeptine products, data shows. Fifteen cases were reported in 2022 alone.

Dr. Caleb Alexander, a professor of epidemiology and medicine at the Johns Hopkins Center for Drug Safety and Effectiveness, says tianeptine is colloquially referred to as “gas station heroin” because it offers effects that mimic those of opioids such as a euphoric high and sedation.

The drug is also used off-label in other countries to treat chronic pain, Alexander added.

The ease in which it can be obtained in the US puts people who are struggling with addiction at especially high risk, he said.

“We remain in the midst of an opioid epidemic in this country,” he said. “It’s a product that clearly has a non-trivial potential for abuse, and the fact that it’s available at your nearest gas station, I think, should give pause.”

The clinical effects of tianeptine abuse and withdrawal can mimic those of opioid toxicity and withdrawal, according to the US Centers for Disease Control and Prevention.

Products claiming to include tianeptine are not safe for consumption because they are not regulated by the FDA and may not contain the drug at all, Alexander said. Even products that legitimately contain tianeptine should not be trusted just because the drug is approved for use overseas, he said.

“The potency, the dose and the way that it’s being used when it’s being sold over the counter at gas stations and convenience stores may be quite different,” he added. “It’s up to the FDA and other partners to ensure that the companies produce evidence demonstrating the safety of this product.”

Health care providers and consumers are urged to report adverse events or side effects related to tianeptine to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Anyone who has questions about tianeptine or needs emergency assistance can contact Poison Help at 1-800-222-1222 or PoisonHelp.org.

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