FDA warns about Neptun’s Fix tianeptine supplements after reports of seizures, hospitalizations


The Food and Drug Administration warns consumers not to use or buy products from the dietary supplement brand called Neptune’s Fix after receiving several reports of serious reactions, including seizures and hospitalizations. The FDA says it tests samples for illegal and harmful ingredients.

Neptune’s Fix supplements claim to contain tianeptine, a opioid alternatively prescribed as an antidepressant in some Latin American, Asian and European countries. Tianeptine is not approved for use in the United States

The FDA has previously warned about this “potentially dangerous” substance, as the agency say has been linked to addiction and fatal overdoses.

Bottles of Neptune's Fix that the FDA is investigating for illegal substances
FDA warns consumers not to buy or use Neptune’s Fix products or other products containing tianeptine that are not approved in the United States

FDA


Now authorities fear that other substances may also be mixed into these products, which are sold illegally online and in retailers such as 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 had seizures after consuming the products, the state health department said said. Some required hospitalization. Others showed up in hospitals with a range of other serious symptoms, including hallucinations and vomiting.

It’s unclear which states have reported problems with Neptune’s Fix to the FDA or how long the agency’s testing of the products will take.

An FDA spokesman 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, according to the CDC reported in 2018 that poison control centers had been fielding an increasing number of calls about tianeptine abuse and withdrawal from use of the drug.

The nickname “gas station heroin” due to its wide availability in grocery stores and other small retailers, several states have taken steps to curb sales of the drug. Other brands of tianeptine that the FDA has previously warned about include Za Za and Tianna Red.

Florida Attorney General announced an emergency rule in September to designate tianeptine as a Schedule I controlled substance in the state following moves to tighten restrictions on the substance in Alabama, Georgia, Indiana, Kentucky, Michigan, Mississippi, Ohio and Tennessee.

Federal prosecutors have also gone after companies for smuggling and selling tianeptine products in the US

Emergency rooms have reported increases in reports of users struggling with withdrawal from the drug in recent years, including after efforts to pull the product from store shelves.

Unlike typical antidepressants medicine works by binding to the body’s mu-opioid receptors, causing effects that mimic opioid toxicity and withdrawal. Like other opioids, naloxone have been used to manage tianeptine overdoses.

“We had to put a lot of people in intensive care units (ICUs) because the withdrawal symptoms were so bad and often included delirium that required high doses of sedatives,” Dr. William Rushton, head of the University of Alabama’s Medical Toxicology program, said in a post of the university.


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