CSPI urges FDA to do more to crack down on tianeptine sales

By Hank Schultz contact

- Last updated on GMT

©Getty Images - serggyn
©Getty Images - serggyn

Related tags: Regulation, Adulteration

A nonprofit group has asked FDA to crack down on the sale of tianeptine, an ingredient that is sold as an antidepressant drug in many markets outside of the United States.

In a letter addressed to FDA Commissioner Dr Stephen Hahn, MD, the Center for Science in the Public Interest noted that it had been made aware that products containing tianeptine that were packaged to look like dietary supplements were for sale in convenience stores in Alabama, and are also freely available online.

Antidepressant cloaked as dietary supplement widely for sale

Laura MacCleery, policy director for CSPI, said her group was approached by a private individual who made them aware of the issue in Alabama.  Brandon Lackey is the chairperson the Alabama Association of Christian Recovery Ministries, a network with the capacity to treat 3,000 patients.

“Mr Lackey approached us in the spring saying that in Alabama where he works as a drug treatment counselor he has seen there is widespread availability in corner stores of substances that are essentially opiates in their effects.  That affects his ability to treat his patients,” ​MacCleery said.

Ingredient has known safety concerns

According to a recent study, tianeptine has been a drug of abuse since at least 2000.  The study, published in the June edition of the journal Clinical Toxicology​, noted that the problem does indeed seem to be growing worse in Alabama.  That study, authored by experts from the University of Alabama Birmingham and the Alabama Poison Control Center, looked at poison control center calls to the Alabama center from Jan. 1, 2015 to March 15, 2020.

The study found  of the 84 cases involving atypical tricyclic antidepressants, 48 calls concerned tianeptine.  Of those 48 cases, 37 cases, or 77%, were registered since May 2019. Twenty-seven (56%) of the overall tianeptine cases required medical attention and 17 (35%) were managed in an intensive care unit.  The cases involved both tianeptine intoxication or in some instances withdrawal symptoms. And according to CSPI, FDA’s own adverse event reporting system has recorded more than 470 reports connected to tianeptine, including 55 reports involving death.

“Health care practitioners should be increasingly aware of this xenobiotic as usage may be on the rise,” ​the researchers wrote.

According to researchers in Montpellier, France, a market where the ingredient is prescribed as an antidepressant drug, tianeptine use bears with the risk of ‘activation syndrome,’ in which suicidal ideation can be heightened in sensitive individuals.

“AS symptoms may need to be monitored closely in the weeks that follow the introduction of an antidepressant treatment,”​ they wrote.

CSPI:  Agency could to more

FDA has already issued a consumer warning on the ingredient in 2018 and sent two warning letters​, but CSPI questions whether that has had the desired effect.  The CSPI letter noted that a bill has been introduced in the Alabama legislature to ban the sale of tianeptine in the state. 

 In addition to the convenience store sales, the ingredient is also widely available online. CSPA asserts that at least one of the companies warned in 2018 continues to sell tianeptine under different brand names.  And the ingredient is for sale in bulk quantities online.

“Because FDA has issued enforcement letters but has yet to eliminate tianeptine sales, the agency should continue to make enforcement action against these supplements a priority. We respectfully urge FDA to immediately request enforcement action from the Department of Justice against companies that continue to market, sell, and distribute products with tianeptine,”​ the letter concludes.

FDA did not respond to a request for comment in time for this report.

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