Another Milestone Crossed: Fluoroquinolones, The FDA, and Psychiatric Adverse Events
A Brief Background
As many of you know, Dr. Charles Bennett is a tireless advocate for the fluoroquinolone community. His group SONAR (The Southern Network on Adverse Reaction project) based out of the 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.
Over the years as part of his ongoing work into adverse drug events and reactions, Dr. Bennett and SONAR, have researched and synthesized a tremendous amount of existing data regarding the fluoroquinolones (FQ’s). During that time, our small floxed group has worked closely with Dr. Bennett and SONAR to help facilitate their goals regarding drug safety of the FQ’s.
The Citizen Petition
On September 11, 2014 SONAR filed a citizen petition (Docket #FDA-2014-P-1611) to the FDA requesting that the FDA change the professional labeling of Levaquin (levofloxacin) in other tospecify a more accurate benefit/risk profile in regard to psychiatric adverse events. I had written an earlier article on how the FDA failed to act on the psychiatric petition in the past. You can read that article here.
On July 10, 2018. Dr. Bennett received confirmation from the FDA that they had taken action based on his second Citizen Petition asking for more warnings of Levaquin psychiatric adverse events. Specifically, the FDA indicated it will update the Levaquin and other Fluoroquinolone labels to add the following adverse events: “disturbances in attention, disorientation, agitation, nervousness, memory impairment, and serious disturbances in mental abilities called delirium.” (1) You can read that article here.
It is important to note, that the FDA agreed to add a specific subcategory for “Psychiatric Effects.” Going forward, Levaquin psychiatric adverse events would not be hidden on the label within the general subheading of “Central Nervous System Effects.” This was a tremendous step forward.
Even more significant, however, was the FDA’s statement that it was unnecessary to add psychiatric adverse events to the Levaquin Black Box warning, because there will now be a subcategory for “Psychiatric Effects” within the “Central Nervous System Effects” subheading and that within the current Black Box warning, it already refers to subheading “Central Nervous System Effects.”
Now, I want my readers to step back and take a closer look at the implications. Especially those who have been trying to advocate, warn and seek justice for psychiatric harm by these drugs. It took me, and a few others, a couple of times reading through this information for the implications to fully set in. This statement from the FDA is astonishing. The FDA just acknowledged that since “Psychiatric Effects” will specifically be identified within the “Central Nervous System Effects” subheading, psychiatric adverse events are automatically assumed to be part of the existing Black Box warning.
This means that the FDA has admitted that Levaquin and other commonly prescribed antibiotics in this class already carry a Black Box warning—the most serious type of warning—for psychiatric adverse events including, toxic psychoses, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, and insomnia, suicidal thoughts, attempted suicide, completed suicide, disturbances in attention, disorientation, agitation, nervousness, memory impairment, and serious disturbances in mental abilities called delirium.
It is my wish that no one would ever suffer psychiatric adverse events from these drugs. Again, for those that have been harmed, those that tirelessly seek to advocate and warn, and for those who pursue justice, I am sure that this acknowledgement from the FDA will hold some benefit by raising official awareness, validation of personal experiences, and possibly, for some, the possibility of legal inquiries.
While the FDA noted that it denied some parts of Dr. Bennett’s Citizen Petition, in reality, Dr. Bennett got what he asked for: more psychiatric adverse events in the Levaquin “Warnings and Precautions Section”, a new subheading specifically for “Psychiatric Effects,” and acknowledgement by the FDA that Psychiatric Effects are included, by definition, in the Black Box warning. This was a massive victory for Dr. Bennett and for the floxed community. This was another giant step forward, a milestone if you will, in disclosing the true dangers of these antibiotics. A big thanks to Dr. Charles Bennett and his entire team at SONAR.
(1) FDA. Letter to the Dr. Charles Bennett, MD. 10 July. 2018. TS. Reprinted with permission.
Please stay tuned to MyQuinStory for updated reports on this and other FQ’s related news.