FDA Issues Warning About Supplement Containing Potentially Deadly Antidepressant

The Federal Drug Administration has issued a warning against the use of over-the-counter supplements that contain an antidepressant called tianeptine, due to serious risks including seizures, loss of consciousness and death.

Neptunes Fix brand products have been sold at gas stations, smoke shops and convenience stores and illegally online, according to a statement from the agency. They reportedly contain tianeptine, nicknamed gas station heroin and marketed under the names Coaxil, Stablon and Tatinol. The drug is not approved for medical use in the U.S. and has been banned at least 9 states.

Neptune Resources, LLC elected to voluntarily recall its products, including Neptunes Fix Elixir, Neptunes Fix Extra Strength Elixir and Neptunes Fix Tablets, but the FDA stated Wednesday that it continues to receive severe adverse event reports after use of the products, including deaths.

Consumers, distributors and retailers that have these products should either dispose of them or return them to the place of purchase immediately, the FDA statement said.

The FDA also sent a letter to gas stations and convenience stores to request they immediately stop selling Neptunes Fix products, as well as other products that contain tianeptine. 

The Centers for Disease Control and Prevention has identified the use of tianeptine as a public health risk, with some effects mimicking opioid toxicity and withdrawal.

It is used to improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions in numerous countries across Europe, Asia and Latin America, according to the FDA. 

But the FDA does not approve or review the safety of dietary supplements in the U.S. Because of that, its tools are extremely limited, Dr. Pieter Cohen, an associate professor at Harvard Medical School who studies the regulation of supplements, told NBC News . 

Theyre basically in a situation where they need to ask the company politely if they can take if off the market, Cohen added.

Despite this, Reps. Jeff Jackson (D-N.C.) and Rich McCormick (R-Ga.) led an effort with three other legislators to call on the FDA Commissioner Dr. Robert Califf to act on the use of tianeptine on Jan. 18.

 The urgent need for FDA action on tianeptine cannot be overstated, the lamakers wrote in the letter to the commissioner. 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 unregulated substances like tianeptine.

Need help with substance use disorder or mental health issues? In the U.S., call 800-662-HELP (4357) for the SAMHSA National Helpline .