The FDA is warning two companies for illegal marketing of dietary supplements that contain tianeptine. One of the warning letters was sent to MA Labs LLC, for Vicaine, and the other was sent to Jack B Goods Outlet Store, for Tianaa Red, Tianaa White, and Tianaa Green.
Tianeptine has caused serious adverse events, according to that agency. Tianeptine is illegally used to treat opioid use disorder, and pain and anxiety. It is not a vitamin, mineral, herb, among acid dietary substance; or a concentrate, metabolite, constituent, extract, or combination of those substances.
Dr. Scott Gottlieb, FDA Commissioner, said in a statement, “The bottom line is this: we’ve seen growing instances where profiteers are pushing potentially dangerous compounds – often with unproven drug claims and crossing the line when it comes to what defines a dietary supplement. These potentially illegal activities put the entire dietary supplement industry at risk by confusing consumers, harming patients and tainting good dietary supplement products by associating them with the activities of bad actors.
“In this case, these companies are preying on vulnerable patients who may be seeking alternative treatments to serious medical conditions like opioid use disorder. They’re also selling products with known safety issues. We won’t stand by and allow this to happen.”
The Centers for Disease Control and Prevention (CDC) warned consumers in August 2018 that calls to U.S. poison control centers about tianeptine exposure increased during 2014 – 2017, which suggested a public health risk. There were 207 calls during that time period, which increased from 11 calls in the time period of 2000 through 2013. People reported neurologic, cardiovascular, and gastrointestinal signs and symptoms. Some of these issues mimicked opioid toxicity and withdrawal.
Tianeptine, which is typically marketed as Coaxil or Stablon, is a tricyclic drug used as an antidepressant in Asian, Europe, and Latin America. It is not approved for medical use in the US and is an unscheduled pharmaceutical agent. Case studies report severe adverse effects and death from recreational use of tianeptine.
Most of these cases occurred among people aged 21 to 40 years. Major outcomes were denied as life-threatening symptoms or significant residual disability or disfigurement.
The CDC report states, “In light of the ongoing U.S. opioid epidemic, any emerging trends in drugs with opioid-like effects raise concerns about potential abuse and public health safety.”
