A supplement known as Neptune’s Fix, or “gas station heroin,” has been voluntarily recalled by its maker because it contains an ingredient, tianeptine, that is not approved by the Food & Drug Administration (FDA).
Tianeptine is an unregulated supplement that has been used in some countries as an antidepressant. It is not approved for medical use in the US and has been linked to adverse health effects such as suicidal ideation, accidental overdose, confusion, seizures, and shortness of breath.
The supplement may also contain other harmful ingredients such as synthetic cannabinoids and kavain.
A supplement known as Neptune’s Fix, or “gas station heroin,” has been voluntarily recalled by its maker, Neptune Resources LLC. The US Food & Drug Administration (FDA) says the products—including Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets—contain an ingredient called tianeptine that is not approved for medical use.
Tianeptine is an unregulated supplement sometimes used to treat symptoms of opioid withdrawal or opioid use disorder, explains Ryan Marino, MD, a medical toxicologist, emergency physician, addiction medicine specialist, and assistant professor at Case Western Reserve University. “Tianeptine is an approved antidepressant medicine in many other countries, but in the United States, it has no approved indications and is only available in unregulated supplement form,” Dr. Marino says.
The FDA says that tianeptine is often sold online in tablet or powder form. Neptune's Fix tablets come in 20-count packs or in four-count foil packets. Neptune's Fix Elixir and Extra Strength Elixir are packaged in amber glass bottles. The products, which feature a logo of the Roman God Neptune with a green beard and a trident, were purchased online or at gas stations, smoke shops, and other stores.
The FDA notes that while some countries do use tianeptine to treat depression, some have restricted how tianeptine is prescribed or dispensed. Some countries utilize a label warning indicating possible addiction risk.
The FDA warns that some companies make “dangerous and unproven claims that tianeptine can improve brain function and treat anxiety, depression, pain, opioid use disorder, and other conditions.”
“These substances may be produced commercially by drug manufacturers or in clandestine laboratories to mimic the effects of more well-known illicit/controlled substances such as marijuana, cocaine, opioids, etc,” according to a review published in Pain and Therapy.
“There have been increasing reports of people developing problem use and adverse outcomes associated with tianeptine, but not a lot of good data,” Dr. Marino adds. He notes that tianeptine itself has multiple negative effects on humans, including opioid-like effects that could lead to dependency and withdrawal.
The FDA says that the supplement may lead to “life-threatening events,” including suicidal ideation or behavior in people under 25. More so, the supplement may lead to accidental overdose, confusion, seizures, and shortness of breath, among other effects—all of which can be compounded by the use of alcohol. Using tianeptine alongside monoamine oxidase inhibitors (MAOIs) could be life-threatening.
Adverse effect reports involving tianeptine are on the rise, the FDA says. Between 2000 and 2013, there were 11 reports. In 2020, there were 151 poison control center cases involving tianeptine exposure.
The CDC says that in New Jersey, between June and November 2023, 17 patients between the ages of 28 and 69 years of age experienced altered mental status in addition to “tachycardia (11 patients), hypotension (10), seizure (eight), prolonged QT interval (seven), prolonged QRS duration (four), and cardiac arrest (one),” due to Neptune’s Fix. More so, 13 of the 17 patients were admitted to an intensive care unit, while seven of the 17 had endotracheal intubation. No deaths were reported.
Tianeptine may not be the only harmful ingredient included in the supplement. Kavain (or Piper methysticum, which has been used to treat anxiety) and synthetic cannabinoids were also found in tested samples, according to the Centers for Disease Control and Prevention (CDC). The FDA warns that some ingredients may not even be included on the label.
“Any non-FDA approved OTC herbal-like product may contain any possibility of contaminants,” says Kirk Cumpston, DO, medical director of the Virginia Poison Center at VCU Health. “Synthetic cannabinoids can cause seizures, hallucinations, and brain injuries. They are not detected on routine drug screens,” Dr. Cumpston says.
How to stay safe
Physicians should help patients with opioid dependence, chronic pain, depression, or anxiety to seek help through approved, safe treatments.
The conversation around supplement safety goes far beyond Neptune’s Fix, says Mark Stovall, CAT, CMHT, the regional executive director for American Addiction Centers. “We need more awareness around drugs and supplements not approved by the FDA. There needs to be more conversations around the health risks and addictions that can develop. Americans must know that just because you can purchase supplements at gas stations doesn’t mean they’re safe. Everyone needs to know we have no way of knowing what is in non-approved FDA supplements because there’s zero oversight of the ingredients,” Stovall says.
“It is important to remember that any supplement can contain other substances, adulterants, or even just not contain what is listed,” Dr. Marino echoes.
He says that MDs who sense that a gas station or shop is carrying unapproved supplements should contact law enforcement. “With more education around the dangers of gas station drugs, we can better protect everyone and help curb the epidemic of addiction in our country,” Stovall adds.