The Food and Drug Administration is warning consumers not to use or purchase any products from the supplement brandafter receiving multiple reports of severe reactions, including seizures and hospitalizations. The FDA says it is testing samples for illegal and harmful ingredients.
Neptune’s Fix supplements purport to contain tianeptine, analternative prescribed as an antidepressant in some Latin American, Asian and European countries. Tianeptine is not approved for use in the U.S.
The FDA has previously warned about this “potentially dangerous” substance, which the agencyhas been linked to addiction and deadly overdoses.
Now authorities worry other substances may also be mixed into these products, which are being sold illegally online and in retailers like gas stations and vape or smoke shops.
News of the FDA’s testing comes less than a month after health officials in New Jersey warned they had identified a cluster of poisonings linked to tianeptine products including Neptune’s Fix.
More than half of the patients suffered seizures after ingesting the products, the state’s health department. Some required hospitalization. Others showed up at hospitals with a variety of other serious symptoms, including hallucinations and vomiting.
It is unclear which states have reported issues with Neptune’s Fix to FDA or how long the agency’s testing of the products will take.
An FDA spokesperson did not immediately respond to a request for comment.
“Gas station heroin”
Authorities have moved to crack down on other tianeptine supplements in recent years, after the CDCthat poison control centers had been fielding a growing number of calls over tianeptine abuse and withdrawal from use of the drug.
Nicknameddue to its wide availability in convenience stores and other small retailers, several states have taken steps to curb sales of the drug. Other brands of tianeptine the FDA has previously warned about include Za Za and Tianna Red.
Florida’s attorney generalan emergency rule in September to designate tianeptine as a Schedule I controlled substance in the state, after moves to tighten restrictions on the drug in , , , , , , and .
Federal prosecutors have also gone after companies forand tianeptine products in the U.S.
Emergency rooms have reported surges in reports of users struggling over withdrawal from the drug in recent years, including after efforts to pull the product from store shelves.
Unlike typical antidepressants, theworks by binding to the body’s mu opioid receptors, causing effects that mimic opioid toxicity and withdrawal. Similar to other opioids, has been used to manage tianeptine overdoses.
“We were having to put a lot of people in the intensive care units (ICUs) because the withdrawal symptoms were so bad and often included delirium requiring high doses of sedating medications,” Dr. William Rushton, head of the University of Alabama’s Medical Toxicology program, said in aby the university.