Consumers have been given a fresh warning by the Food and Drug Administration (FDA) to avoid using a product marketed as a supplement, Neptune’s Fix, because it contains tianeptine, a potentially dangerous substance linked to dangerous side effects.
Also known as gas station heroin, the FDA warns in a Jan. 23 alert that products under the brand name Neptune’s Fix have been linked to seizures, loss of consciousness and, in some extreme cases, hospitalization. It is sold at gas stations, convenience stores, vape shops and online.
“These products may interact, in life-threatening ways, with other medications a consumer may be taking,” the FDA said in its warning.
“The agency is actively investigating adverse event reports in conjunction with local and state health departments.”
Between 2000 and 2013, there were 11 calls to the poison control center regarding tianeptine, according to the FDA. While in 2020 there were at least 151 calls. The last data concerning tianeptine deaths was back in 2018 when three people died. It’s unclear if there have been other deaths linked to the substance since.
As a result of the FDA warning, the parent company behind Neptune’s Fix has agreed to voluntarily recall all the offending products in the range, Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir and Neptune’s Fix Tablets.
Tianeptine, which is also called Coaxil or Stablon, is used as an antidepressant in some countries around Europe, Asia, and Latin America. According to the Centers for Disease Control and Prevention, the drug is an unscheduled pharmaceutical agent that can mimic the effects of opioid toxicity and withdrawal.
Tianeptine Not Approved For Use in the United States
An initial warning was released by the FDA last November, warning consumers not to purchase Neptune’s Fix or other products containing tianeptine. Fears at the time were it was potentially dangerous, despite being marketed as a quick fix to improve brain function and treat anxiety, depression, pain, and other conditions, all of which have proven to be false. According to the FDA, the drug does not meet the definition of a dietary supplement, regardless of any reports to the contrary. It’s also not approved for use in the United States, and that is unlikely to change anytime soon.In January, the FDA sent a letter to convenience stores, gas stations and other organizations urging them to stop selling Neptune’s Fix and other tianeptine-containing products. At this stage, it’s unclear if any of these products are still available in stores. Customers are being warned to throw away any stash they might still have of Neptune’s Fix products.
Lawmakers have also raised concerns about tianeptine being used on American soil. On Jan. 18, a bipartisan group of lawmakers, Reps. Jeff Jackson, Rich McCormick, John Rose, Lauren Boebert and Wiley Nickel sent a letter to the FDA outlining several requests. Highlights include calling for regulators to research and provide guidance on using tianeptine, asking to share any research already conducted on the substance and whether there will be any action to reclassify it under the Controlled Substance Act.
