Forrest General physicians alert FDA following drug study findings

HATTIESBURG, Miss. (WDAM) - Physicians from the Forrest General Hospital’s Family Medicine Residency Clinic (FMRC) alerted the Food and Drug Administration (FDA) to the findings of a drug study they conducted on tianeptine withdrawal.

Tianeptine is an antidepressant drug not currently approved for medical use by the FDA, but it is available without a prescription in supplements, like “ZaZaRed” and “Pegasus,” at local convenience stores and online. Its common availability at gas stations has earned it the nickname “gas station heroin.”

Dr. Robert “Bob” Brahan, Pharmacist Joseph Nosser, Dr. Rambob Rouhbakhsh, Dr. John Lloyd Martin and Dr. Adam Purvis co-authored a paper entitled “Tianeptine Withdrawal: A Cause for Public Health Concern in Mississippi” after encountering patients with concerning and dangerous side-effects from tianeptine use.

“The article may be the first of its kind, identifying a case series of patients who suffered from withdrawal from tianeptine that we doctors knew little about prior to patient encounters,” said Rouhbakhsh, who serves as the FMRC program director.

These physicians became alerted to tianeptine withdrawal when they encountered two separate cases where patients at FMRC exhibited opioid withdrawal symptoms while consuming high daily doses of tianeptine-based products.

Nosser, the clinical pharmacist at FMRC, said the lack of FDA approval had not stopped some companies from illegally marketing and selling tianeptine products for self-treatment purposes.

“They are also making dangerous and unproven claims that tianeptine can improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions,” Nosser said.

The supplements are available in 46 states. However, Alabama, Michigan, Minnesota and Tennessee have outlawed the sale of tianeptine products. Georgia also recently proposed legislation to classify tianeptine as a Schedule I drug (drugs with no currently accepted medical use and high risk for abuse).

In Mississippi, Nosser said that several local city and county governments are also taking action against tianeptine. For example, the Pearl River County Board of Supervisors recently approved a motion to ban the sale of tianeptine-based products within the county limits.

“Case reports (single patient case) and case series (multiple patient cases) like ours are typically the very first pieces of information that identify new risks,” said Rouhbakhsh. “These types of studies trigger greater awareness and may induce more case reports/series. After sufficient awareness occurs, medical researchers may attempt larger observational studies by accessing data resources. These products are not well studied. But, thanks to case reports like the one we have published, the FDA is getting more information about the effects of these products.

“In addition to publishing the study, we also contacted the FDA to alert them of our findings.”

As a result of the growing concerns, the FDA’s website issued a warning on the use of tianeptine.

“Tianeptine presents safety risks and can be abused,” reads the warning. “Cases described in medical journals, in calls to U.S. poison control centers and 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.”

According to their findings, the paper’s authors said the effects of tianeptine abuse and withdrawal could mimic opioid toxicity and withdrawal. The most commonly reported clinical symptoms are neurologic (agitation, drowsiness, confusion, coma), cardiovascular (rapid heart rate, high blood pressure, heart rhythm issues) and gastrointestinal (nausea, vomiting, diarrhea).

Rouhbakhsh said that while the paper will help bring attention to a growing health problem, it was also a good learning experience for Drs. Martin and Purvis, who were serving as FMRC residents at the time the paper was authored.

“While information provided in this paper will bring attention to the dangers of tianeptine, this was a great opportunity for these recently-graduated residents to take part in helping put this paper together,” Rouhbakhsh said. “It helped highlight the role primary care doctors play in identifying new risks and how we can contribute to the safety, knowledge and health of our communities. We are the actual front line of healthcare, and it was a unique opportunity for our residents to contribute new knowledge to the medical science community.”

The Journal of the Mississippi State Medical Association will publish the physicians’ paper in an upcoming edition.

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