June 2014 - SONAR issues "Black Box Warning" on Levaquin for Mitochondrial Toxicity:
3 years after I was diagnosed with Mitochondrial damage (6 years after my fight began) the Southern Network on Adverse Reactions (SONAR) issued a request for a Black Box Warning on Levaquin and all Fluoroquinolones for Mitochondrial Toxicity. A "Black Box Warning" is the strongest action the FDA has, short of pulling the drugs from the market. Or in this case, the entire class of drugs - Fluoroquinolones. This will be the third Black Box Warning on this class of drugs.
This is a horrific condition as Mitochondria are the powerhouse of your cells and body. Mitochondria are responsible for 90% of the energy needed by the body to sustain life.
The excerpt is as follows:
The Southern Network on Adverse Reaction (SONAR) project
The South Carolina Center of Economic Excellence for Medication Safety
The South Carolina College of Pharmacy
University of South Carolina, Columbia, South Carolina, USA
The Southern Network on Adverse Reactions (SONAR), submits this Citizen Petition (Petition) under section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA). SONAR requests that the Commissioner of the Food and Drug Administration (FDA) require changes in the professional labeling for Levaquin in order to specify a more accurate benefit/risk profile for this antibiotic.
A. ACTION REQUESTED
This Petition requests that the FDA change the professional labeling for Levaquin under Section 505(o)(4) to FDCA or other appropriate FDCA section(s), in response to new safety information. This action will also strengthen the quality of the Levaquin science base and decisions based on it.
Possible Mitochondrial Toxicity
Fluoroquinolones, including Levaquin, may cause Mitochondrial Toxicity
due, in part, to an insufficiency of ATP. Mitochondrial conditions that are
due to an insufficiency of ATP include developmental disorders of the
brain, optic neuropathy, neuropathic pain, hearing loss, muscle weakness,
cardiomyopathy, and lactic acidosis. Neurodegenerative diseases, like
Parkinson's, Alzheimer's and amyotrophic lateral sclerosis (ALS) have
been associated with the loss of neurons due to oxidative stress generated
by reactive oxygen species (ROS) related to Mitochondrial Toxicity.
Peripheral neuropathy, hepatoxicity, glucose disturbances, and
phototoxicity may result from Mitochondrial Toxicity.
A special thank you to the Quinolone Vigilance Foundation for obtaining a copy of this document. The QVF and more information can be found here.
A full copy of this warning, as delivered to the FDA can be found here as well.
Black Box Warning on Levaquin for Mitochondrial damage
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FDA Warning against eating meat treated with Fluoroquinolones:
These drugs are still found in the tissue of cooked meat. I'm simply re-poisoning myself every time I eat non-organic meat.
FDA Warning against eating meat from Animals treated with Fluroquinolones
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The Flox Report:
A good amount of information.
The Flox Report
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FDA to Bayer: Stop lying when trying to peddle your toxic money makers:
How is it Doctors don't know the dangers of the drugs they prescribe daily? Well, the drug companies routinely hide information and use false claims to promote their drug as 'safe'. We don't hear about these things, they don't make the news. Instead once enough people have been seriously injured or even died, drugs are silently withdrawn from the market. Then comes the onslaught of Class Action Lawsuit ads that we are now so desensitized to seeing.
But here is one such instance. The FDA sent a warning to Bayer to cease and desist their false marketing claims of safety on the Fluoroquinolone AVELOX. This is the best copy I have, if anyone out there finds a better copy, Please forward it to me so I may post.
FDA Warning to Bayer over false claims of safety of AVELOX
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