PENNSYLVANIA, USA — The Food and Drug Administration is warning consumer not to purchase or use products that contain tianeptine because the substance can interact with other medications in a potentially lethal way.
Tianeptine products, often sold under the brand name Neptune's Fix, can cause seizures, loss of consciousness and death, the FDA said. Tianeptine is not FDA-approved for any medical use, but it is illegally sold with claims to improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions.
"FDA has received severe adverse event reports after use of Neptune‘s Fix products, including seizures and loss of consciousness leading to hospitalization," the organization said in a press release. "Consumers who experience a bad reaction to any tianeptine product should seek immediate medical help."
The FDA urges anybody who has bought products containing tianeptine to throw them away or return them to the store. The organizations also says it sent a letter to places that tend to sell these products to press the retailers to stop selling them.
Neptune Resources, LLC has agreed to voluntarily recall all lots of Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir and Neptune’s Fix Tablets to the consumer level.
The FDA says these products are often sold online and at gas stations and vape or smoke shops.
The FDA recommends calling Poison Help at 1-800-222-1222 to connect to your local poison center.
Health care professionals and consumers are asked to report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online at MedWatch Online Voluntary Reporting Form, or;
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
