FDA cautions consumers to avoid tianeptine products owing to serious dangers

The US Food and Drug Administration is urging customers not to buy or use tianeptine products due to reports of severe adverse events, including death.

According to lawmakers, FDA Commissioner Dr. Robert Califf should act immediately on tianeptine products due to the need for more research.

The FDA says the drug treats serious depression in Europe, Asia, and Latin America. Although not licensed for usage in the US, tianeptine products are sold illegally online and at gas stations, vape shops, and smoke shops.

FDA said tianeptine products are sold as dietary supplements to promote brain function and treat anxiety, depression, pain, and opioid use disorder in the US.

FDA says some people use tianeptine as an opioid substitute or to self-treat anxiety or sadness. Agitation, sleepiness, confusion, perspiration, rapid heartbeat, high blood pressure, nausea, vomiting, slowed or halted respiration, coma, and death may occur.

“Neptune Resources, LLC has agreed to voluntarily recall all lots of Neptune's Fix Elixir, Extra Strength Elixir, and Tablets to the consumer level,” the FDA states. In January, it wrote to convenience stores, gas stations, and other organizations to stop selling tianeptine products.

The FDA's Center for Food Safety and Applied Nutrition's Adverse Event Reporting System receives and monitors reports of adverse events or product complaints for foods, dietary supplements, and cosmetics. At least two deaths have been reported in recent years related to tianeptine dietary supplements.