They warn consumers not to buy products with tianeptine in the US because of their serious risks.

(CNN) — The US The Food and Drug Administration (FDA) warns consumers not to buy or use products with tianeptine because it continues to receive reports of serious adverse effects, including deaths, related to the substance.

Some legislators FDA Commissioner Dr. Robert Calif urged immediate action on the use of tianeptine products, arguing that more research is needed into its effects.

According to the FDA, this antidepressant is prescribed in Europe, Asia, and Latin America for the treatment of major depressive disorder. However, it is not approved for use in the United States, and tianeptine products are often sold illegally online and at gas stations, vape shops, and tobacco shops.

In the United States, tianeptine products are often marketed as dietary supplements that can improve brain function and treat conditions such as anxiety, depression, pain and opioid use disorder, according to the FDA.

According to the FDA, some people use tianeptine as an alternative to opioids or to self-treat anxiety or depression. Side effects may include agitation, drowsiness, confusion, sweating, tachycardia, hypertension, nausea, vomiting, slow or stopped breathing, coma, and death.

The agency issued a warning in November about tianeptine products sold under the name Neptune’s Fix. In an update released Tuesday, the FDA asked consumers not to use or buy any products containing tianeptine, saying that use of these products under the name Neptune’s Fix has been associated with “reports of serious adverse effects,” including seizures, loss of consciousness. and death.

“The agency is actively investigating reports of adverse effects in conjunction with state and local health departments,” the FDA said. “These products can interact with other medications taken by the consumer, in a potentially fatal manner.”

“Neptune Resources, LLC, has agreed to a voluntary consumer recall of Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir and Neptune’s Fix tablets,” the agency says. In January, it sent a letter to convenience stores, gas stations and other establishments advising them to stop selling products containing tianeptine.

Neptune Resources did not respond to a request for comment on its products.

In a letter sent to the FDA on Thursday, Representative Jeff Jackson, Democrat of North Carolina, and Rich McCormick, Republican of Georgia, asked the agency if it was working with the Drug Enforcement Administration on the possibility of adding tianeptine to the drug schedule. Controlled Substances Act.

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

Between Jan. 1, 2019, and Dec. 31, 2023, about 1,100 “human exposures” involving tianeptine were reported, Poison Centers of America spokeswoman Maggie Maloney said in a statement released Wednesday. About 400 exposures were reported in 2023, with the number of cases increasing each year since 2019.

“Most reported cases of tianeptine exposure involved adults who intentionally used the substance to get high,” he said.

In recent years, at least two deaths related to 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 Adverse Event Reporting System, which receives and monitors adverse event reports. Complaints about food, dietary supplements or cosmetic products.

The agency began receiving reports of adverse events related to tianeptine products in 2015. Since then, consumers have reported 35 adverse events related to tianeptine products, the data show. 15 cases were reported in 2022 alone.

Professor of Epidemiology and Medicine at the Johns Hopkins Center for Drug Safety and Effectiveness, Dr. Caleb Alexander says tianeptine is colloquially known as “gas station heroin” because it provides effects that mimic opioids, such as a high and sedation. .

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

The ease with which it can be obtained in the United States puts people struggling with addiction at particularly high risk, he said.

“We are drowning in 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 should, I think, give you pause.”

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

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

“The strength, quantity and method of use can be very different when sold over the counter at gas stations and convenience stores,” he added. “It is up to the FDA and other partners that companies present evidence demonstrating the safety of this product.”

Healthcare professionals 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 tynaptine or needs emergency help can contact Poison Help at 1-800-222-1222 or at PoisonHelp.org.