Concern Growing Over Dangerous, Accessible Antidepressant

721
Neptune’s Fix, a supplement that contains tianeptine, is sold in some convenience stores. Courtesy Food and Drug Administration

By Stephen Appezzato

Health officials are concerned that a dangerous drug is easily accessible at gas stations and convenience stores around the state.

The term “gas station heroin” has been used to describe tianeptine, an antidepressant that is found in some unregulated dietary supplements. Tianeptine is not approved by the Food and Drug Administration and, according to the New Jersey Department of Health (NJDOH), the drug – commonly found in supplements with the brand names Neptune’s Fix and Za Za Red – has opioid-like effects.

Michael Litterer, vice president of RWJBarnabas Health’s Institute for Prevention and Recovery (HIPR), said his staff started hearing more about tianeptine close to a year ago.

“Most of it is anecdotal,” he said. “There hasn’t been good monitoring and there’s not real good testing for it.” But through the institute’s substance prevention work across Monmouth County, Litterer and his staff learned more and more parents and children are talking about the drug.
The HIPR is a grant-funded arm of the RWJBarnabas system which focuses on substance abuse disorder, programs for prevention, early intervention and recovery support services for people with addictions.

Litterer said the unregulated nature of these supplements containing tianeptine poses a particular challenge.

Tianeptine is a dangerous antidepressant with opioid-like effects and is not approved by the FDA. Courtesy Food and Drug Administration

“It’s actually an antidepressant and it’s used pharmaceutically in other countries. Here in the U.S. it’s marketed as a dietary supplement, so I think that’s challenge No. 1,” he said.

“It falls through that loophole of FDA regulation (by) claiming that it’s a dietary supplement. It’s just not regulated and monitored the same way as a pharmaceutical.”

In the United States most dietary supplements do not require FDA approval. This means that, while tianeptine is a prescription medication in some European, Asian and Latin American countries, products containing the substance in the U.S. are unregulated.

“It’s a mixed bag in what these products actually contain… because they’re not regulated,” Litterer said. Not only is there a question of the product actually containing the substance it claims to, there is also the questions of purity, he said.

Litterer likened these issues to the “age of fentanyl” – a patient would report they used cocaine, not understanding they overdosed because the cocaine contained fentanyl. This poses a challenge for health care workers, as they can’t solely rely on patient reporting, but must also conduct comprehensive testing.

According to the NJDOH, naloxone – a life-saving medication that can reverse an opioid overdose – is potentially effective in treating tianeptine overdoses. “But, again, it depends on what that product contains, because it can easily contain synthetic cannabinoids and many other things,” Litterer said, that could make naloxone less effective.

Those who take tianeptine quickly develop a tolerance to it. This means users “have to take more and more, which is obviously an issue,” Litterer said. “When you take anything in excess, the dangers just exponentially grow.”

Last year 27 overdose cases involving tianeptine were reported in New Jersey. While that number is small, officials are concerned that, considering the accessibility of the drug, more cases will occur.

U.S. Rep. Frank Pallone (D-6) has been leading a federal push to crack down on supplements containing tianeptine, urging further regulatory action and demanding the National Association of Convenience Stores and the Council for Responsible Nutrition explain how they protect consumers from dangerous and accessible products.

To date, nine states have banned tianeptine. In New Jersey, a bill cracking down on the substance was floated during the 2022-2023 Legislative session. That bill remains unsigned.

In January, supplement company Neptune Resources, which makes Neptune’s Fix, issued a nationwide recall of its tianeptine-containing product. But Pallone is concerned these and similar products are still on store shelves around the country. Pallone said in recent months these products have caused a “dramatic spike” in calls to the New Jersey Poison Control Center.

“I think the biggest thing is, going beyond the ‘gas station heroin,’ we have to take a comprehensive public health approach, which obviously starts with public awareness,” Litterer said. “We have to educate people on the warning signs, the danger, the false perception of safety – all the things that people just don’t understand,” he said, warning many may think if these products are readily available in convenience stores, they are likely safe.
“Step Two (in combatting the problem) is monitoring and regulating,” Litterer said. “We need to know how prevalent is this? What’s happening? What are the signs and symptoms? None of that happens without that public health surveillance,” he said.

Finally, Litterer said, “We have to educate our providers and our first responders. Think about the early days of the overdose epidemic, we had to educate people on how to use Narcan (naloxone) and what it looked like when someone was overdosing. You unfortunately have to do all of that, because it looks very differently, especially with this,” he said.

Above all, Litterer said, our society must examine its relationship with drugs. Banning and regulating specific substances helps, but more will pop up in a “whack-a-mole” fashion, he said. “We really need to continue the conversation around the root causes of why substances like this keep popping up and keep being a problem.”

The article originally appeared in the April 4 – April 10, 2024 print edition of The Two River Times.