FDA issues urgent warning over supplement linked to sudden deaths after just three uses
The FDA issued a warning to the public about a deadly drug masquerading as a harmless supplement.
Dr Marty Makary, FDA Commissioner, wrote an open letter to fellow public health officials in which he advised them spread the word about 'gas station heroin' – powder, liquid, and tablet forms of the unapproved drug tianeptine.
'I want the public to be especially aware of this dangerous product and the serious and continuing risk it poses to America's youth,' Dr Makary said.
'While the FDA is closely following the distribution and sale of these products, it is critical that you appreciate the magnitude of the underlying danger of these products, and disseminate information about it.'
Tianeptine—an opioid-like drug with a high risk of addiction—is not banned under federal law. Yet deaths have occurred after just a few pills.
Despite its risks, it is sold as a 'harmless' dietary supplement in gas stations and online, even though the FDA has repeatedly warned that it doesn't qualify as one.
They say it was never legally sold as a supplement before 1994—the key cutoff for approval—making its current sales outright illegal.
Still, Dr Makary and the FDA have pledged to crack down on sellers violating the law: 'While the FDA is closely following the distribution and sale of these products, it is critical that you appreciate the magnitude of the underlying danger of these products, and disseminate information about it.
'Let's be proactive in understanding and addressing the use of tianeptine products, which are available even to our nation's youth.'
The substance has been on the government's radar for years.
New Jersey poison control logs reported by the CDC last year revealed a rise in emergencies linked to the brand Neptune's Fix.
Between June–November 2023, 20 emergency calls documented 17 patients (ages 28–69) collapsing in altered mental state's, dangerous high heart rate, seizures, and cardiac arrest.
Thirteen victims were admitted to the ICU with seven placed on ventilators—though no deaths were reported.
Most had ingested the tianeptine-kavain blend, but 6 mixed it with opioids, benzos, or kratom, amplifying the crisis.
Nine were repeat users, indicating high potential for addiction.
'I am very concerned, Makary said. 'I want the public to be especially aware of this dangerous product and the serious and continuing risk it poses to America's youth.'
Tianeptine has some devastating side effects.
While inducing a state of euphoria, it can bring about seizures, agitation, confusion, sweating, nausea, vomiting, drowsiness, coma, and death.
The supplement has been linked to at least four fatal overdoses since first hitting US shelves in the 2010s.
Some of the most popular products include Tianaa, Zaza, Neptune's Fix, Pegasus, and TD Red, and can be found in gas stations, vape shops, and online.
'Case reports in the medical literature describe U.S. consumers ingesting daily doses on the order of 1.3 to 250 times (50 mg to 10,000 mg) the daily tianeptine dose typically recommended in labeled foreign drug products,' Dr Makary added.
Tianeptine is an approved as an antidepressant in some Latin American, Asian and European countries.
The FDA has warned that quitting tianeptine can trigger opioid-like withdrawal symptoms, including crippling cravings, sweating, chills, diarrhea, and agonizing muscle pain.
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