Do not take the supplement tianeptine. It’s ‘worse than heroin.’

| Mar 11, 2021 | Pharmaceutical Liability |

Tianeptine fist appeared on the scene in the mid-2010s. Regulators were cracking down on opioids like oxycodone and fentanyl. People addicted to those drugs were seeking alternatives, including heroin. Some found an over-the-counter supplement called Tianaa, or tianeptine.

People who have used the drug say that it creates a euphoria like opioids and heroin, but that a person’s tolerance to tianeptine jumps quickly. That could make it especially risky for overdoses.

“The withdrawal that I experienced from heroin was [overshadowed] by the withdrawal from this poison,” wrote one person who became addicted to tianeptine.

We’re using the word “drug,” even though tianeptine is being sold as a supplement. But no one in the industry doubts tianeptine is a drug. Selling it as a supplement is illegal, but tianeptine is widely available online even now.

Numerous studies have found tianeptine is a hazard to public health and may be a risk for abuse, overdose and addiction. Yet the U.S. Food and Drug Administration has only recently taken any action against sellers.

In November, the FDA issued an alert to the public and sent notices to sellers to cease and desist. Yet tianeptine is still being sold.

Has the FDA done enough soon enough?

According to Consumer Reports, tianeptine has been a problem for at least 10 years. However, the danger became readily apparent by at least 2018.

That year, lawmakers in Michigan were fighting to ban the drug on the state level in an effort to get it off the streets. Several people the Michigan State Police interviewed had said that tianeptine was “worse than heroin.”

In addition, there were several studies by that time that linked tianeptine to addiction. According to a review of FDA emails obtained through the Freedom of Information Act, the agency remained unaware of those studies, however.

In May 2018, the journal Clinical Toxicology ran an article examining tianeptine-related poison control calls and found several adverse events. The article concluded that tianeptine was inadequately regulated and posed a risk to public health.

By 2018, even the FDA’s own adverse-event database contained a number of alarming incidents involving the drug.

By summer, the Centers for Disease Control and Prevention was sounding alarms. It had identified a sharp uptick in tianeptine-related poison control calls that had begun a few years earlier. The CDC said the evidence suggested an emerging public health risk and recommended public outreach.

However, the FDA did not take action until November 2020.

That action appears to have been largely ineffective. At least one of the sellers the FDA warned in November is still selling tianeptine supplements, according to Consumer Reports.

Advocates and even former FDA staffers admit that the agency’s response has been slow. A former FDA official pointed to the “extensive” process required before the FDA can pull a supplement from the market. However, tianeptine is not an ordinary supplement; it is an unregulated drug and should not be on the market at all.

Sometimes, regulators don’t do enough to protect the public from dangerous products. In an ideal world, a drug like tianeptine would be pulled from shelves in days or weeks. In reality, the FDA is struggling to pull it from the market even though research has clearly found it to be dangerous.

If you or a loved one has been injured by tianeptine or any drug, consider taking legal action. An attorney experienced in pharmaceutical liability may be able to hold the drug maker financially responsible for your losses and suffering.