Reports of serious adverse events related to dietary supplements containing the unapproved opioid-like antidepressant tianeptine have prompted the Food and Drug Administration (FDA) to issue warning letters to companies marketing these products for pain and anxiety management, as well as for opioid use disorder treatment.
“This action is part of a broader effort we have underway to re-examine our resources and authorities related to products marketed as dietary supplements, and outline a new policy on how we intend to more vigorously fulfill our obligations to protect consumers from dangerous products and unlawful claims,” said FDA Commissioner Scott Gottlieb, MD “In this case, these companies are preying on vulnerable patients who may be seeking alternative treatments to serious medical conditions like opioid use disorder.”
In August 2018, the Centers for Disease Control and Prevention (CDC) published study data in the Morbidity and Mortality Weekly Report which suggested an increase in tianeptine use in the US and urged healthcare professionals to be “vigilant for potential cases of tianeptine exposure.” Neurologic, cardiovascular, and gastrointestinal side effects made up the majority of adverse events reported in those exposed to the drug, while withdrawal effects mimicked those of opioid withdrawal.
While approved in Europe, Asia and Latin America, tianeptine is an unscheduled pharmaceutical agent in the US that has been linked to serious adverse events, including death, when used for recreational purposes. Under the Federal Food, Drug, and Cosmetic Act, dietary supplements containing tianeptine would be considered adulterated and are not safe for consumption.
In a press release, Gottlieb promised the FDA would be taking more action to protect consumers. “These warning letters are one part of our enforcement plan and we’ll continue to take action to protect public health.”
For more information visit FDA.gov.