The products contain tianeptine, a potentially dangerous substance that can cause severe adverse effects, including death.
On November 21, the FDA warned consumers not to buy or use any Neptune's Fix products because they may contain tianeptine, a tricyclic antidepressant with opioid-like effects, and other potentially harmful ingredients.
Neptune's Fix is sold online and at gas stations and other retail stores. These, and other products containing tianeptine, often claim to help boost brain function or treat depression, anxiety, or opioid use disorder (OUD).
The agency says it has received reports of serious harm related to these products, including hospitalizations due to seizures and loss of consciousness. Moreover, people who experience a negative reaction to any tianeptine-containing product should seek medical help immediately.
What is tianeptine?
Tianeptine is a tricyclic antidepressant not FDA-approved in the United States for any medical conditions. However, in other parts of the world, including Europe, Asia, and South America, the drug is sometimes prescribed with restrictions to treat depression under the brand names Coaxil, Stablon, and Tatinol.
Despite FDA warnings, vendors continue to market and sell tianeptine illegally, often in products that claim to treat anxiety, depression, and other conditions.
However, the drug has the potential for abuse, especially among those with opioid use disorder. Moreover, in the U.S., people often take higher doses than what's typically prescribed in other countries, resulting in agitation, drowsiness, confusion, sweating, rapid heartbeat, high blood pressure, nausea, vomiting, breathing difficulties, coma, and death.
What's more, the number of Poison Control Center calls involving tianeptine is on the rise. In the U.S., 11 cases occurred between 2000 and 2013. However, in 2020 alone, poison control centers reported 151 instances of tianeptine exposure.
According to the FDA, tianeptine is also known as:
- Tianeptine sulfate
- Tianeptine sodium powder
- Tianna Green
- Tianna Red
- Tianna White
The FDA is testing Neptune's Fix products and will provide an update as more information emerges. In the meantime, the agency urges healthcare providers and consumers to report any adverse effects related to this and other illegal tianeptine products through the FDA's MedWatch Safety Information and Adverse Event Reporting Program.