Recently, in July 2018, Dr. Bennett published a paper about Fluoroquinolone Associated Suicide to the European Journal of Internal Medicine with the assistance of the floxed community.
In an astonishing statement from the FDA, they 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.
Adverse events added by the FDA are some of those requested by Dr. Bennett previously.
The FDA is strengthening the current warnings in the prescribing information that the fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects.
This is a good high profile opportunity for us to continue to warn the general public, family and friends about the dangers posed by the Fluoroquinolones.
I am ecstatic about the new label changes. But given the FDA’s past track record, I will not happy until every medical professional, who has the ability to prescribe a FQ, is familiar with the label changes and safety precautions.
I think it was no coincidence that the FDA denied the mitochondrial citizen petition during the same time frame that they approved label changes. Right now the FDA is not acknowledging even the risk of mitochondrial toxicity.
Dr. Charles Bennett has been able to successfully publish a paper titled “Fluoroquinolone-Related Neuropsychiatric and Mitochondrial Toxicity: a collaborative investigation by scientists and members of a social network.”
It is very disturbing that an antibiotic, which is often given out for routine infections, may result in violence, anger toward others, and horribly, may result in suicide-related adverse events.
We believe that the attention given the Fluoroquinolones through the combined media stories, past rallies, citizen petitions, in addition to community members meeting directly with FDA officials, provided some of the impetus, in part, for the scrutiny of the Fluoroquinolones being prescribed for these common health conditions.
On August 24th, 2015, members from the FQ community met with staff from the FDA in a third meeting to address the various FDA failures to adequately warn the general public about the true dangers FQ’s pose to the general public, especially our children.
Dr. Linda Martin, Dr. Alan Redd, David Melvin, and John Fratti submitted an abstract for the UMDF Symposium on behalf of the FQ community. We are pleased to announce that, after being peer-reviewed by the UMDF Abstract Review Committee, their abstract was selected as a poster for the Symposium.
“The legal and Industry Guidance bars are not too high. The problem is that the FDA has failed to do its job regarding Fluoroquinolone antibiotic safety.”, Dr. Charles Bennett, PharmedOut 2015
On June 10th, 2015 representatives from the Fluoroquinolone community met with Senate Staffers at the Dirksen Senate Building in Washington, D.C. to ensure pressure is maintained on the FDA in regards to updated warnings.
“You can’t do what I do and think the drug companies don’t notice you.” With the media scrutiny and the Citizen Petitions filed over the last year you can bet that Bennett has gotten the attention of some very powerful entities; entities that are going to push back in an effort to silence or undermine our message.
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Mito Organizations
Compounding pharmacies.
