FDA Warns of Rising Dangers of Unapproved Drug Tianeptine


News Picture: FDA Warns of Rising Dangers of Unapproved Drug Tianeptine

WEDNESDAY, Feb. 23, 2022 (HealthDay News)

The US Food and Drug Administration has issued one other pointed warning concerning the risks posed by tianeptine, an antidepressant that’s not permitted for any kind of medical therapy within the United States.

Topping the record of doable dangers from taking the drug: unintended poisoning and dependancy,

why an dependancy danger? Tianeptine — generally marketed on-line as a therapy for melancholy and nervousness — belongs to a category of medicines often called “opioid receptor agonists.” That means the drug has an identical influence on the mind as heroin and different opioids, corresponding to oxycodone, methadone, hydrocodonemorphine and opium.

In the midst of an ongoing opioid epidemic, Americans have been more and more searching for out tianeptine as a readily accessible — if unlawful — opioid various, based on the FDA’s Center for Drug Evaluation and Research.

“In the US, reports of bad reactions and unwanted effects involving tianeptine are increasing,” the FDA acknowledged in its newest warning. ,Poison management middle circumstances involving tianeptine publicity have elevated nationwide, from 11 complete circumstances between 2000 and 2013 to 151 circumstances in 2020 alone.”

Poisoning can manifest as confusion, sweatinga quick heartbeat, blood stress spikes, nausea, vomiting, agitation, and/or sleepiness. It may immediate a notable slow-down in respirationand typically it will possibly set off a complete shutdown of the respiratory system, resulting in coma or loss of life.

The FDA’s backside line: “Consumers should avoid all products containing tianeptine.”

According to a 2019 evaluation carried out by the US Drug Enforcement Administration (DEA), these merchandise embody counterfeit tablets that mimic the looks of hydrocodone and oxycodone, Tianeptine can be obtained on-line in bulk powder type.

Though usually marketed on-line beneath the names “Coaxil” or “Stablon,” the FDA notes that the drug can also be bought —typically in gasoline stations or comfort shops — beneath a wide selection of cute and catchy names, together with “Tianna,” “Tianna Green,” “Tianna Red” and “Tianna White.”

The FDA has tried earlier than to rein in use of the drug, with an eye fixed to guidelines spelled out by the Federal Food, Drug and Cosmetic Act.

Those guidelines mandate that every one dietary dietary supplements comprise a minimal of 1 “dietary ingredient,” that means a vitamin, mineral, herb, amino acid, and/or meals product or extract. Supplements may comprise non-dietary components, so long as they’re meals components and/or formally acknowledged as protected.

Because tianeptine doesn’t meet any facet of that customary, the FDA deemed that “dietary dietary supplements containing tianeptine are adulterated.” So, the FDA issued its first official warning in 2018 to 2 dietary complement corporations that had been brazenly promoting merchandise containing tianeptine.

The FDA’s worries over tianeptine use are shared by Dr. Arthur Chang, chief medical officer within the division of environmental well being science and apply with the National Center for Environmental Health (NCEH) on the US Centers for Disease Control and Prevention,



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Though he famous that tianeptine is, in reality, permitted for the therapy of melancholy and nervousness In sure international locations all through Europe, Asia and Latin America, Chang confirmed that “tianeptine has abuse potential, and several studies report severe adverse effects and even death from its misuse or abuse.”

The downside, he famous, is that via its opioid-like means to bind to sure opioid receptors, “tianeptine can produce euphoria at excessive doses.” And that signifies that “people may become addicted to tianeptine, and experience significant withdrawal symptoms when they stop chronic use.”

The FDA’s newest warning seems to replicate a rising concern that using tianeptine is turning into more and more widespread.

The DEA did a overview of National Poison Data System information collected between 2000 and 2017. That overview discovered “a rapid and marked increase in tianeptine-related [poisoning] calls during this time period.”

The research particularly famous that whereas the drug was implicated in simply 5 poisoning calls again in 2014, that determine rose to 38 in 2015, 83 by 2016, and 81 by 2017. And most of these calls concerned comparatively younger individuals, between the ages of 21 and 40.

More info

Consumer Reports particulars the historical past of tianeptine within the United States.

SOURCES: Arthur Chang, MD, MSchief medical officer, division of environmental well being science and apply, National Center for Environmental Health, US Centers for Disease Control and Prevention, US Food and Drug Administration, assertion, Feb. 10, 2022

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