FQ Black Box Warnings and related information

* This area will continue to grow. This is only a fractional glimpse at the available information on this class of poisonous drugs. I will continue to add to this as my energy allows*

Important: There is a “class effect” on these drugs. This means that all drugs in the Fluoroquinolone class cause the same damage. When a Black Box Warning gets added to one drug, all Fluoroquinolones will carry the same warning. Levaquin, Avelox and Cipro included.

Other than pulling the drug from market, a “Black Box Warning” is the strongest action the FDA can take.


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.


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 full copy of this document can be found here: Levaquin Black Box Warning for 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.

Internal FDA memo shows fda is fully aware that fluoroquinolones target human dna and damage mitochondria

The following internal FDA memo dated April 17, 2013, issued by the Food and Drug Administration’s Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, was obtained through the freedom of information act. This Pharmacovigilance Review shows the FDA is aware that the root cause of Peripheral Neuropathy in Fluoroquinolone Toxicity is Mitochondrial Toxicity. Even further,  this also clearly shows that the FDA is fully aware that the mechanism of action in Mitochondrial Toxicity is an attack on human mtDNA

Mito tox 1

Mito tox 2

Thank you David at MyQuinStory for this memo.



FDA Peripheral Neuropathy Black Box Warning:



SONAR issues Black Box warning for Psychiatric effects:



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

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.

Federal Register: 11,5,1996 Volume 61, Number 215

The following excerpt is from the following rule change at the
FDA back in November of 1996 which immedately follows

“(d) Conditions of use. It is used in drinking water as follows:
(1) Chickens and turkeys–(i) Amount. 25 to 50 parts per million of
enrofloxacin in drinking water.
(ii) Indications. Chickens: Control of mortality associated with
Escherichia coli susceptible to enrofloxacin. Turkeys: Control of
mortality associated with E. coli and Pasteurella multocida (fowl
cholera) susceptible to enrofloxacin.
(iii) Limitations. Do not use in laying hens producing eggs for
human consumption. Administer medicated water continuously as sole
source of drinking water for 3 to 7 days. Prepare fresh stock solution
daily. Effects on the reproductive function of turkeys have not been
determined. Treated animals must not be slaughtered for food within 2
days of the last treatment.
Individuals with a history of hypersensitivity to quinolones should avoid exposure to this product.”

In plain English; if you have had a reaction to the fluoroquinolones AVOID TURKEY AND CHICKEN that has been treated with these drugs. Period. To ignore this caveat is to invite yet another reaction.