The U.S. Food and Drug Administration has issued a renewed warning against the purchase or use of any products containing tianeptine, commonly referred to as "gas station heroin," just under a week after lawmakers urged the federal body to take action against its use.
Tianeptine is an approved antidepressant in some countries, but not in the U.S. However, it continues to be sold here under brand names like Neptune's Fix, Tianna and Zaza online and at convenience stores and gas stations under the guise of being a health-improvement supplement.
The FDA first warned about tianeptine products, specifically from Neptune's Fix, in November, and late Tuesday, the federal agency said it continues to receive reports of the products causing adverse effects, including seizures, loss of consciousness and death.
Not only are they continuing, but reports of bad reactions and unwanted side effects involving tianeptine are rising nationwide. According to the FDA, total poison control center cases increased from just 13 between 2000 to 2013 to 151 cases in 2020 alone.
Regulators say consumers are drawn to purchase tianeptine products due to companies often marketing them as treatments to "improve brain function and treat anxiety, depression, pain, opioid use disorder, and other conditions."
But the FDA warns the products can interact with other medications in a consumer's body, including other antidepressants or anti-anxiety medications, and cause bad reactions.
SEE MORE: Lawmakers urge FDA to take action on 'gas station heroin'
Additionally, the CDC points to evidence showing tianeptine abuse and withdrawal can mimic opioid toxicity and withdrawal. This point was also made in a Jan. 18 letter signed by five bipartisan House representatives urging the FDA to more tightly regulate tianeptine due to its "opioid-like qualities."
The FDA says those with a history of opioid use or dependence may be at an increased risk of abusing tianeptine, and that abuse can cause harmful effects including drowsiness, rapid heartbeat, high blood pressure, vomiting, slowed or stopped breathing and more.
"People seeking to treat their ailments sometimes mistake a product as being safe because it's easily available, whether online or even at gas stations," the FDA said. "But availability is no indication of effectiveness or safety. This is especially true of tianeptine, an unapproved drug associated with serious health risks and even death."
Though the FDA does not approve dietary supplements for safety and effectiveness before they're sold to the public, it said Tuesday that Neptune Resources — the maker of Neptune's Fix — has now agreed to voluntarily recall three of its tianeptine products. It also said it sent a letter to convenience stores, gas stations and other organizations on Jan. 11, urging them to stop selling Neptune's Fix and any other tianeptine-containing products.
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