People seeking to treat their ailments sometimes mistake a product as being safe because it’s easily available, whether online or even at gas stations. But availability is no indication of effectiveness or safety. This is especially true of tianeptine, an unapproved drug associated with serious health risks & even death.
Tianeptine is not approved by the U.S. Food & Drug Administration for any medical use. Despite that, some companies are illegally marketing & selling products containing tianeptine to consumers. They are also making dangerous & unproven claims that tianeptine can improve brain function & treat anxiety, depression, pain, opioid use disorder, & other conditions.
Although the FDA has warned consumers about tianeptine, vendors continue to market & sell this drug. The FDA is aware that tianeptine has been sold online, typically in tablet or powder form.
Tianeptine Isn’t FDA Approved for Any Medical Use
Tianeptine is an unapproved drug in the U.S. Although other countries have approved tianeptine to treat depression & anxiety, some have restricted how tianeptine is prescribed or dispensed, or revised the drug label to warn of possible addiction.
In the U.S., reports of bad reactions & unwanted effects involving tianeptine are increasing. Poison control center cases involving tianeptine exposure have increased nationwide, from 11 total cases between 2000 & 2013 to 151 cases in 2020 alone.
Tianeptine Presents Safety Risks & Can Be Abused
Cases described in medical journals, in calls to U.S. poison control centers, & in reports to the FDA suggest that tianeptine has a potential for abuse. People with a history of opioid use disorder or dependence may be at particular risk of abusing tianeptine.
Some people have turned to tianeptine as an opioid alternative, or to self-treat anxiety or depression. Medical journals & reports to the FDA suggest that adverse events may occur when tianeptine is taken at doses higher than the doses prescribed in the countries where the drug has been approved. Some people may have difficulty stopping their use of tianeptine & may experience withdrawal symptoms. The clinical effects of tianeptine abuse & withdrawal can mimic opioid toxicity & withdrawal, according to the Centers for Disease Control & Prevention (CDC).
The FDA has identified cases in which people experienced other serious harmful effects from abusing or misusing tianeptine by itself or with other drugs, including antidepressants & anti-anxiety medicines. These effects included agitation, drowsiness, confusion, sweating, rapid heartbeat, high blood pressure, nausea, vomiting, slowed or stopped breathing, coma, & death.
How to Protect Yourself & Your Family
Consumers should avoid all products containing tianeptine, including those claiming to treat an ailment or disorder. Talk to your health care provider if you need help with opioid dependence, depression, anxiety, pain, or other ailments. There are approved treatments for those & related conditions.
Help is available to treat opioid or other substance use disorders. Find state-licensed providers who specialize in treating substance use disorders & addiction at www.findtreatment.gov. Or call 1-800-662-HELP (4357).
The FDA has taken steps to protect people from unapproved tianeptine products, including warning consumers that tianeptine is an unsafe food additive & not a dietary ingredient. We have issued warning letters to companies illegally marketing tianeptine products as dietary supplements & unapproved drugs. We also have issued import alerts to help stop tianeptine shipments at our borders.
The FDA will continue to take regulatory action to discourage the importation & marketing of unapproved tianeptine products. In the meantime, you can report an adverse event involving tianeptine by using the FDA’s MedWatch Safety Information & Adverse Event Reporting Program:
- Complete & submit the report online.
- Download the form or call 1-800-332-1088 to request a reporting form sent to you in the mail, then complete & return to the address on the form, or submit it by fax to 1-800-FDA-0178.
If you have a question about a medication, call your pharmacist or the FDA. The FDA’s Division of Drug Information (DDI) will answer almost any drug question. DDI pharmacists are available by email at [email protected], & by phone, at 1-855-543-DRUG (3784) & 301-796-3400.
Source: FDA Consumer Updates