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.
Drug’s that can mutate DNA and create a disease process are downright scary. They start the ball rolling on a pathology that often appears later on..
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.
One hundred patients who went to the Emergency Room and received a Fluoroquinolone were studied, in ninety nine of those cases, errors were made with the Fluoroquinolone!
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.
On Thursday May 12, 2016 the FDA contacted those who have been pursuing label changes for the Fluoroquinolones and issued a public statement that the FDA is requiring label changes for antibacterial drugs called fluoroquinolones
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.
On Nov. 5th, the true stars of our community took to the podium at the FDA to tell their personal stories. I, along with countless others, were humbled and honored. This meeting represented a huge step in the progress we are making to gain complete recognition of the travesty that the fluoroquinolone class of pharmaceuticals has wrought upon society, to achieve justice for those that have been damaged by these drugs, and to prevent future unnecessary pain and suffering not only for this generation, but for generations to come.
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.
The Ashley Madison affair has led to extortion, divorces, ruined lives, lost jobs, and even suicides. But, let me let you in on another dirty little secret, one much worse than Ashley Madison…
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.
Why would the FDA make such an outrageous decision to enter into an unprecedented agreement to monitor post-marketing drug surveillance with a private company run by ex-pharmaceutical executives? The FDA would be better off looking at its FAERS data. If they did, they would see drug signals that they have ignored, especially for FQ’s.
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Mito Organizations
Compounding pharmacies.
