DFW Metroplex: The U.S. Food and Drug Administration (FDA) recently issued a new and urgent warning about using any products, such as Neptune’s Fix, that contain tianeptine. They sent a letter on January 11, 2024 to convenience stores, gas stations, vape/smoke shops and other companies advising the retailers to stop selling any tianeptine-containing products. In November, they issued an initial warning and have continued to receive reports on the adverse effects of tianeptine, including seizures, loss of consciousness and death.
Neptune Resources, LLC announced on January 28, 2024 that they are issuing a voluntary nationwide recall of Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir, and Neptune’s Fix Tablets products due to the presence of tianeptine. The announcement said they haven’t received reports of adverse effects and are issuing the recall because tianeptine isn’t FDA-approved and “the presence of tianeptine renders the products unapproved drugs for which safety and efficacy have not been established and, therefore, are subject to recall.”¹
Neptune’s Fix Elixir and Extra Strength Elixir are used as a supplement and are packaged in amber glass bottles with a “shrink sleeve” label that covers the entire cap/bottle and is perforated at the cap to facilitate opening. Neptune’s Fix tablets are packaged in 20-count blister packs held in small boxes or 4-count foil packets. All Neptune’s Fix products are being recalled. The product can be identified by the name Neptune’s Fix and its logo which is an illustration of the Roman God Neptune with a green beard and a trident. The products were distributed Nationwide to wholesale and retail customers.
What is Tianeptine and Why is it Dangerous?
Tianeptine, commonly known as “gas station heroin,” is an unapproved drug in the U.S., but has been approved in other countries in Europe, Asia and Latin America to treat depression and anxiety. The drug commonly induces agitation and can also cause effects such as a fast heart rate, high blood pressure, confusion, nightmares, drowsiness, dry mouth and nausea. The more serious effects include slowed or stopped breathing, coma, heart arrhythmia and death.² The drug can also interact with other medications with deadly consequences.
The fact that it has been easily available in retail stores and online, can lull consumers into thinking it is a safe product. Retailers have skirted the fact it is not FDA-approved by selling it as a dietary supplement, which incurs significantly less rules and oversight. In fact, tianeptine products are being touted “with claims to improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions.”³
“There have been reported instances of individuals using tianeptine as an opioid substitute or to self-treat anxiety and depression. Many have also used it with the sole intention of getting high. Although it can be dangerous for anyone to use this medication without a doctor’s supervision, people with a history of opioid use disorder may be at increased risk of abusing it. Some have even become addicted to tianeptine and suffered from symptoms of withdrawal.⁴ Although self-medication might seem to provide temporary relief, over time it only worsens the symptoms anxiety, depression or an opioid use disorder. When someone is looking for true healing and recovery, a medical and therapeutic treatment center like Santé Center for Healing is the place to turn. We have treated substance use disorders that include co-occurring mental health conditions for 27 years. If we aren’t the right fit for an individual, we will help them find a place that is,” says Santé’s Medical Director, Melissa Pennington, D.O., FASAM, CEDS.
For more information on Santé Center for Healing click here.
