The FDA Fails Again With Fluoroquinolone Psychiatric Labeling Changes

“More and more people are having psychiatric problems as a result of these drugs,” said Dr. Charles Bennett referring to adverse events caused by the Fluoroquinolones, a commonly prescribed family of powerful antibiotics.

Bennett’s group SONAR (The Southern Network on Adverse Reaction project) based out of University of South Carolina School of Medicine provides a systematic approach to pharmacovigilance and drug safety. Wherever necessary, SONAR seeks to make global policy changes that reflect the true dangers that certain drugs could pose to the general public.

Dr. Bennett and Sonar have been tireless advocates in their pursuit to bring the dangers of the Fluoroquinolones into the public eye.

In regard to their penchant for causing psychiatric problems, amongst other life-altering adverse events, Bennett says, “It’s just a hidden secret. It should not be a hidden secret.”

Dr. Bennett’s words ring true. The mental health adverse events caused by the Fluoroquinolones such as levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), ofloxacin and gemifloxacin (Factive) to name a few, have long been a hidden secret; a secret too easily dismissed and relegated to the fringes of medicine.

The Petition

The psychiatric adverse events needed to be brought into the light. So much so that on June 17, 2019, SONAR and Dr. Bennett submitted a citizen petition to the FDA requesting a black box warning to specifically identify psychiatric adverse events, including suicide and suicide-related adverse events.

The citizen petition also requested the FDA add Fluoroquinolone-Associated Disability (FQAD) to the black box warning and implement a risk evaluation and mitigation strategy for the drugs. FQAD was a termed coined by the FDA in 2015 during its formal review identification for a constellation of symptoms that have been identified in the FDA’s Adverse Event Reporting System (FAERS) in review of data in the fluoroquinolone safety reports.

Bennett’s petition was the last in a series of proposed labels changes highlighting the inherent dangers of the Fluoroquinolone.

Not Safe

The Fluoroquinolones have slipped through the cracks of the medical establishment.  Personally, I hear from hundreds of individuals each year who have been permanently damaged harmed in one way or another by these drugs and whose pleas for help and justice fall on deaf ears.

I have also worked with Dr. Bennett on several occasions and contributed to his “Fluoroquinolone-associated Suicide” paper published in the European Journal of Medicine on July 20, 2018, that highlights the neuro-psych dangers of these drugs.

Many medical practitioners believe that these drugs have a proven safety and efficacy record, when in fact the opposite is true.  The spectrum of damages that one can experience, including psychiatric problems, along with their documented ability to cause delayed adverse events, falls outside the diagnostic paradigm of most medical practitioners who in-turn view these claims as preposterous.

Many practitioners either miss these adverse events or attribute them to something else.  Either way, this perpetuates the false safety record of the drug and the suffering experienced by an untold number of individuals.

Disappointing Response

The FDA’s response to the latest label change petition confirms what Dr Bennett and other advocates like me, have said.  On August 28, 2020, more than a year after the citizen petition was submitted, the FDA denied their request saying the drug had already undergone numerous label updates to inform prescribers and patients of the drug’s risk.

“Such risks are adequately communicated in Levaquin’s approved labeling,” the FDA said in their denial letter. What the FDA is saying is that basically the drug family has enough warnings already, we don’t need to add more.

What the FDA fails to recognize is that although there are strict warnings on the labels, practitioners are still not heeding the warnings, with an estimated 22 million people in the United States use the generics of Levaquin and Cipro alone.

Recently, more doctors across the country have been prescribing Fluoroquinolones to treat COVID-19 related pneumonia.

In a news article ABC’s WRTV investigative news team reached out to Janssen, the maker of Levaquin, for a response to Bennett’s petition.

“At Janssen, our first priority is the well-being of the people who use our medicines. Janssen is reviewing the Safety Labeling Change Notification and working with the FDA to ensure labeling will be updated appropriately to facilitate the safe and appropriate use of LEVAQUIN®,” said Kelsey Buckholtz, Janssen spokesperson in a statement to RTV6. “LEVAQUIN® (levofloxacin) has been used for nearly 20 years to treat bacterial infections, including those that may be serious or life-threatening. LEVAQUIN® is part of the important fluoroquinolone class of anti-infective prescription medications, and its safety profile remains well-known and established.”

To reiterate, Janssen says that Levaquin’s safety profile “remains well-known and established.”

Levaquin’s True Safety Profile

Although it is hard to exactly quantify Levaquin’s true lethality because the FDA admits that only between 1% and 10% of all adverse events to pharmaceuticals ever get reported (1).  Figuring conservatively at 10% reporting, between 1997 and 2020 Levaquin alone (not including other drugs in this family) has caused upwards of over 29,000 deaths and 461,000 adverse events.  If you go with the 1% reporting percentage, the deaths go up to 290,000 and the adverse events to 4,000,000.  

Levaquin Adverse Events 10% Reporting

Adverse Events 461,000
Death Cases 29,000

Levaquin Adverse Events 1% Reporting

Adverse Events 4,610,000
Death Cases 290,000

The true numbers of deaths, permanent disabilities, and walking wounded is much higher than what is assumed, which is horrifying.

Walking Wounded

The role of the Food and Drug Administration should be one of watchdog, watching out for the safety of the general public, but they fail appallingly. Instead, like a general that sends thousand of soldiers to their certain death just to erode the the enemy, the FDA does likewise. For the Food and Drug Administration it doesn’t matter how many people’s lives are utterly destroyed, just as long as some lives are saved and a disproportionate profit is earned.

For each live saved, how many lives are destroyed? Yes, the deaths are tragic but so are what I call the “walking wounded.” In first aid and triage the walking wounded are injured persons who are of a relatively low priority.  The Fluoroquinolone walking wounded are much like the COVID-19 Long Haulers; those invisible people who are permanently maimed in the battle, but not counted as a tragic statistic. Thye are not the focus of the battle, but should be. I believe the true number of walking wounded that are associated with the Fluoroquinolones is incalculable. 

Conclusion

If policy makers, like the FDA, continued to dismiss the alarms that are raised, it lessens the amount of energy put towards drug safety, curbing the use of these drugs, and researching academic medical solutions for the toxicity. Their repeated refusals to strengthen warnings on these dangerous drugs, reinforces bad practices by doctors and alienates the multitudes that become damaged and disabled from these medications.  Thanks to the FDA and pressure from the pharmaceutical industry, Fluoroquinolone Toxicity does not have legitimate recognition. In other words, the problem continues on, relegated to the dark fringes of medicine, and it remains like what Dr. Bennett said, “a hidden secret.“

I have been in this for almost fourteen years and I have no idea the exact count of disenfranchised and damaged people wandering about like battle weary survivors of an apocalypse, and I probably never will. All I know is that they are there, and there many more than I had even begun to imagine when I started this dubious endeavor.

There is something inherently wrong with all the drugs that are based on the quinoline substrate. There is a thread of poorly understood idiosyncratic toxicity that spreads out like a crack in the foundation and affects all of the drugs based off of this platform. 

There is enough evidence that the FDA knows about the fluoroquinolone toxicity epidemic that is happening, but their true client is the the industry and the FDA exists, first and foremost, towards protecting the interests of the manufacturers.