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.
"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.
Sadly, the FDA review states that children experience the same Levaquin Adverse Events as adults. This means that the children have the possibility of experiencing adverse events that are consistent with mitochondrial toxicity.
We believe that our meeting, in addition to the extensive media attention, offers the best hope for action by the FDA on Fluoroquinolones to date.
This is the final part in a two part hard hitting OP-ED series why WEGO Health is NOT consistent with Fluoroquinolone Community goals.
We must not let the FDA drop the ball and dismiss these legitimate serious concerns. We are asking everyone to email the FDA using the following letter.
The fox is constantly trying to get into our hen house to control the data we read, control our narrative, and control our perceptions and the FDA is allowing this to happen.
