Authorities have recalled Neptune’s Fix, the supplement known as ”gas station heroin”, and have warned people not to buy due to reports of severe adverse effects.
Tianeptine, an antidepressant that is not approved for use in the US by the Food and Drug Administration, is readily bought at gas stations, convenience stores and online, the Centre for Disease Control and Prevention said.
The FDA announced on 23 January that they continue to receive “severe adverse event reports” after people have used Neptune’s Fix products.
They have gotten reports of seizures, loss of consciousness that has led to hospitalisation and even death.
After this announcement, the FDA issued a voluntary nationwide recall of Neptune’s Fix.
The products are being recalled due to containing tianeptine, an ingredient that is not FDA-approved for any medical use, the company said in an announcement. They have been subject to a recall as the products’ safety and efficacy have not been established.
All of their products are being recalled, including Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir, and Neptune’s Fix Tablets to the consumer level.
The FDA said in their warning announcement that the product could interact with other medications in life-threatening ways.
The tianeptine products are illegally sold with claims that they can improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions, the FDA said.
The health authority also advised in a risk statement put in the company announcement that “there is a reasonable probability of life-threatening events including suicidal ideation or behaviour for children, adolescents, and young adults 25 and younger.”
The FDA added that people could unintentionally overdose or experience confusion, seizures, drowsiness, dry mouth, and shortness of breath, which may be exacerbated by alcohol use.
They also warn that using tianeptine along with antidepressants, known as monoamine oxidase inhibitors, is potentially serious and could be life-threatening.
The CDC also said that 20 exposure calls from healthcare facilities of tianeptine use in 17 people, showing an “uncharacteristic spike” in cases with severe associated clinical effects, with synthetic cannabinoid receptor agonists identified in samples of the ingested products.
Out of the 17, 13 were admitted to the ICU and seven of the 17 underwent endotracheal intubation. There were no deaths, the CDC said.
The CDC warned that tianeptine products might be adulterated with synthetic cannabinoid receptor agonists or other drugs.
The FDA issued a letter on 11 January to convenience stores, gas stations and other organisations urging them to stop selling Neptune’s Fix and other products that contain tianeptine.
In a statement from Neptune Resources posted by the FDA, it said: “Neptune Resources LLC’s distribution channels have not reported any adverse events from the use of its products. The products are being recalled because they contain tianeptine, an ingredient that is not FDA-approved for any medical use.”
A representative for Neptune’s Fix said to CBS that they suspected serious injuries resulting from using their products were likely due to knockoffs made by a rival, that the company claims mixed in cannabinoids and other substances, the outlet reported.
“I have had difficulty convincing the FDA to shift their attention to the counterfeiter,” the spokesperson told the outlet.
The Independent has left a message for Neptunes Resources requesting a comment.