There is a new warning about the potential risks associated with supplements.
The Food and Drug Administration (FDA) issued a fresh warning on Tuesday regarding supplements containing tianeptine, commonly known as “gas station heroin.” These products, notably sold under the name Neptune’s Fix and commonly found in gas stations, convenience stores, and online, have been associated with serious side effects such as seizures, loss of consciousness, and even fatalities.
Despite an initial caution from the FDA in November, reports continue to surface of individuals experiencing adverse effects from these supplements. Tianeptine, an antidepressant approved in some international regions but not in the United States, can induce side effects related to the nervous system, heart, and stomach, resembling symptoms of opioid toxicity and withdrawal, as outlined by the Centers for Disease Control and Prevention.
In the U.S., the substance is illicitly marketed as a dietary supplement, often touted by retailers as a solution for enhancing brain function and addressing conditions such as anxiety, depression, pain, and opioid use disorder. The FDA has been actively investigating adverse events associated with these products, emphasizing the potential life-threatening consequences when combined with other medications.
Dr. Pieter Cohen from Harvard Medical School, specializing in supplement regulation, expressed concern over the illicit sale of tianeptine, highlighting systemic issues. Dietary supplements in the U.S. lack FDA approval and are not subject to agency review for safety and efficacy.
In response to the FDA’s warning, Neptune Resources, the manufacturer of Neptune’s Fix, has voluntarily agreed to recall its products, including Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir, and Neptune’s Fix Tablets. The extent to which these products may still be available in stores remains uncertain.
The FDA disclosed that at least 12 states have prohibited the sale of tianeptine, and on January 11, the agency issued a letter urging convenience stores, gas stations, and other retailers to cease selling Neptune’s Fix and any other products containing tianeptine.
This recent FDA warning aligns with recent calls from House lawmakers for Dr. Robert Califf, the FDA commissioner, to take decisive action against the use of tianeptine, underscoring the urgency of addressing this public health concern.
Discussion about this post