FDA Warns Neptune’s Fix May Cause Seizures, Loss of Consciousness and Other Life-Threatening Side Effects

Neptune’s Fix recall has been issued and the FDA has sent warning letters to gas stations and convenience stores, asking them to remove all tianeptine-based supplements from from shelves.

Federal drug regulators are warning consumers not to use recalled Neptune’s Fix products, which contain tianeptine, and may cause overdoses and other potentially serious side effects, including seizures, loss of consciousness and life-threatening interactions with other medications.

The U.S. Food and Drug Administration (FDA) issued a statement this week, indicating that a Neptune’s Fix recall has been issued by the manufacturer, and that a letter has been sent to convenience stores, gas stations and other retailers, urging them to stop selling all tieneptine-containing products.

Neptune’s Fix was marketed as a dietary supplement, containing the drug tianeptine, which is often referred to as “gas station heroin”. Tianeptine is an opioid receptor, which is prescribed in some other countries as an antidepressant, but has not been approved for medical uses in the United States. However, it is found in over-the-counter supplements like Neptune’s Fix, which are marketed to improve brain function, anxiety, depression, pain and opioid use disorder.

Tianeptine Exposure Risks

Side effects of tianeptine can have serious consequences, and the FDA indicates that the agency continues to receive severe adverse event reports after the use of Neptune’s Fix, including reports of seizures, loss of consciousness and death.

The FDA first warned about tianeptine exposure risks in November 2018, but there continued to be a marked and steady rise in reported adverse reactions linked to dietary supplements. In February 2022, the FDA issued another tianeptine warning, alerging consumers about the dangers associated with these over-the-counter supplements.

According to the FDA, consumers with a history of opioid use disorder or dependence could be at a higher risk of abusing tianeptine due to its similarly addictive and euphoric effects. Abuse and misuse of the supplement can result in severe side effects that include confusion, rapid heartbeat, elevated blood pressure, nausea, slowed or stopped breathing, coma, and death.

Poison control centers have confirmed massive increases in reports involving tianeptine exposure, with the number of reactions going from 11 cases between 2000 and 2013 to 151 cases in 2020 alone. Common signs of a tianeptine reaction include seizures, loss of consciousness, and death.

Neptune’s Fix Recall

Federal health officials began investigating Neptune’s Fix brand products in November 2023 after discovering the use of tianeptine in their products. At the time of the initial warning, the manufacturer indicated that the use of tianeptine was listed on the label, as well as other harmful ingredients not on the label.

This month, a Neptune’s Fix recall was issued by the manufacturer, Neptune Resources, LLC, impacting all lots of Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir, and Neptune’s Fix Tablets.

The FDA sent out warning letters on January 11, urging retailers to stop selling Neptune’s Fix and any other tianeptine containing products. Consumers, distributors, and retailers are being advised to either dispose of the products or return them to the place of purchase immediately.

Consumers and healthcare professionals should report any adverse reactions or side effects related to the use of this product to the FDA’s MedWatch Adverse Event Reporting Program. For individuals experiencing side effects of Neptune’s Fix, the FDA directed consumers to contact Poison Help at 1-800-222-1222 to connect to their local poison control center.