FDA Warns of Supplements Containing Illegal Drug Tianeptine
01.25.24
The agency issued a warning about “Neptune’s Fix” supplements, and all others containing the substance, which can serious, potentially lethal side effects.
The U.S. Food and Drug Administration (FDA) reiterated a warning it originally made in November 2023 regarding adulterated products containing the drug tianeptine which are masquerading as dietary supplements.
Tianeptine, which is approved in some regions as an antidepressant drug, hasn’t been approved for any application by the FDA. Since it originally warned consumers about tianeptine products, including a particular brand of them called Neptune’s Fix, the agency has continued to receive adverse event reports about the products, including reports of seizures, loss of consciousness, and death.
According to the U.S. Centers for Disease Control and Prevention (CDC) tianeptine toxicity and withdrawal can mimic the effects of opioid toxicity and withdrawal.
The products may also interact with medications in life threatening ways, according to FDA. Neptune Rersources, LLC has agreed to voluntarily recall all lots of Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir, and Neptune’s Fix Tablets, and consumers, distributors, and retailers of the products should either dispose of them or return them to their place of purchase immediately, FDA reported.
Neptune’s Fix and other tianeptine products are often purchased online, and at gas stations, vape/smoke shops, and other locations, according to FDA. The agency sent a letter to several convenience store, gas station, and other organizations urging retailers to stop selling all products containing tianeptine.
Tianeptine, which is approved in some regions as an antidepressant drug, hasn’t been approved for any application by the FDA. Since it originally warned consumers about tianeptine products, including a particular brand of them called Neptune’s Fix, the agency has continued to receive adverse event reports about the products, including reports of seizures, loss of consciousness, and death.
According to the U.S. Centers for Disease Control and Prevention (CDC) tianeptine toxicity and withdrawal can mimic the effects of opioid toxicity and withdrawal.
The products may also interact with medications in life threatening ways, according to FDA. Neptune Rersources, LLC has agreed to voluntarily recall all lots of Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir, and Neptune’s Fix Tablets, and consumers, distributors, and retailers of the products should either dispose of them or return them to their place of purchase immediately, FDA reported.
Neptune’s Fix and other tianeptine products are often purchased online, and at gas stations, vape/smoke shops, and other locations, according to FDA. The agency sent a letter to several convenience store, gas station, and other organizations urging retailers to stop selling all products containing tianeptine.
