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Black Box Warnings
List of Fluoroquinolones
FDA Medication Guides
Fluoroquinolones in the Media
Awareness and Education
* 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*
BLACK BOX WARNINGS
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 petitions fda for “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) petitioned the FDA for a Black Box Warning on Levaquin and all Fluoroquinolones for Mitochondrial Toxicity. A “Black Box Warning” is the strongest action the FDA has, other than pulling the drugs from the market. Or in this case, the entire class of drugs – Fluoroquinolones.
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.
Thank you David at MyQuinStory for this memo.
FDA PERIPHERAL NEUROPATHY Warning – label change:
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.
LIST OF FLUOROQUINOLONES
The first generation is rarely used today. Nalidixic acid was added to the OEHHA Prop 65 list as a carcinogen on 15 May 1998. A number of the second-, third-, and fourth-generation drugs have been removed from clinical practice due to severe toxicity issues or discontinued by their manufacturers.
The drugs most frequently prescribed today consist of Avelox (moxifloxacin), Cipro (ciprofloxacin), Levaquin (levofloxacin), and, to some extent, their generic equivalents.
- cinoxacin (Cinobac) (discontinued by manufacturer)
- nalidixic acid (NegGram, Wintomylon)
- oxolinic acid (Uroxin)
- piromidic acid (Panacid)
- pipemidic acid (Dolcol)
- rosoxacin (Eradacil)
The second-generation class is sometimes subdivided into “Class 1” and “Class 2”.
- ciprofloxacin (Alcipro,Ciprobay, Cipro, Ciproxin, ultracipro)
- enoxacin (Enroxil, Penetrex)
- fleroxacin (Megalone, Roquinol)
- lomefloxacin (Maxaquin)
- nadifloxacin (Acuatim, Nadoxin, Nadixa)
- norfloxacin (Lexinor, Noroxin, Quinabic, Janacin)
- ofloxacin (Floxin, Oxaldin, Tarivid)
- pefloxacin (Peflacine)
- rufloxacin (Uroflox)
Unlike the first- and second-generations, the third-generation is active against streptococci.
- balofloxacin (Baloxin)
- grepafloxacin (Raxar) (removed from clinical use)
- levofloxacin (Cravit, Levaquin, Tavanic)
- pazufloxacin (Pasil, Pazucross)
- sparfloxacin (Zagam)
- temafloxacin (Omniflox) (removed from clinical use)
- tosufloxacin (Ozex, Tosacin)
Fourth-generation fluoroquinolones act at DNA gyrase and topoisomerase IV. This dual action slows development of resistance.
- gatifloxacin (Zigat, Tequin) (Zymar -opth.) (Tequin removed from clinical use)
- gemifloxacin (Factive)
- moxifloxacin (Acflox Woodward, Avelox,Vigamox)
- sitafloxacin (Gracevit)
- trovafloxacin (Trovan) (removed from clinical use)
- prulifloxacin (Quisnon)
- delafloxacin — an anionic fluoroquinoline in clinical trials
- JNJ-Q2 — completed Phase II for MRSA
The quinolones have been widely used in agriculture, and several agents have veterinary, but not human, applications.
- danofloxacin (Advocin, Advocid) (for veterinary use)
- difloxacin (Dicural, Vetequinon) (for veterinary use)
- enrofloxacin (Baytril) (for veterinary use)
- ibafloxacin (Ibaflin) (for veterinary use)
- marbofloxacin (Marbocyl, Zenequin) (for veterinary use)
- orbifloxacin (Orbax, Victas) (for veterinary use)
- sarafloxacin (Floxasol, Saraflox, Sarafin) (for veterinary use)
FDA MEDICATION GUIDES
These “Medication Guides” change often as the drug companies are forced to add warnings and/or admit side effects.
Levofloxacin (LEVAQUIN) Medication Guide
Moxifloxacin (AVELOX) Medication Guide
Ciprofloxacin (CIPRO) Medication Guide
FLUOROQUINOLONES IN THE MEDIA
Our efforts are beginning to pay off – we need to spread the word, this is the only way innocent lives will be spared.
September 2014 – Phoenix, Arizona: Arizona Republic –http://www.azcentral.com/story/news/local/arizona/2014/09/17/critics-demand-stronger-warnings-potent-antibiotics/15759755/
September 2014 – USA Today –http://www.usatoday.com/story/news/nation/2014/09/17/levaquin-antibiotic-side-effects/15767249/
November 2014 – Phoenix, Arizona: ABC – http://www.abc15.com/news/local-news/investigations/experts-top-antibiotic-carries-hidden-side-effects-not-listed-on-the-label
November 2014 – Phoenix, Arizona: NBC – http://www.azcentral.com/videos/news/local/arizona/2014/11/04/18450053/
November 2014 – Detroit, Michigan: Detroit Free Press – http://www.freep.com/story/life/wellness/2014/09/17/antibiotics-warning-labels-fda/15770411/
November 14, 2014 – Detroit, Michigan: ABC – http://www.wxyz.com/news/local-news/investigations/experts-top-antibiotic-carries-hidden-side-effects-not-listed-on-the-label
November 2014 – Indianapolis, Indiana: ABC – http://www.theindychannel.com/news/u-s-world/experts-top-antibiotic-carries-hidden-side-effects-not-listed-on-the-label
November 2014 – Palm Beach, Florida: ABC – http://www.wptv.com/money/consumer/experts-top-antibiotic-carries-hidden-side-effects-not-listed-on-the-label
November 2014 – Cincinnati, Ohio: ABC – http://www.wcpo.com/news/health/healthy-living/levaquin-popular-antibiotic-carries-side-effects-not-listed-on-label
February 2015 – Atlanta, Georgia: COX – http://www.wsbtv.com/news/news/local/woman-says-popular-antibiotic-levofloxacin-killed-/nj5jY/
February 2015 – Atlanta, Georgia: COX – http://www.wsbtv.com/news/news/local/patients-suffer-devastating-side-effects-popular-a/nj4Br/
February 2015 – Atlanta, Georgia: COX – http://www.wsbtv.com/news/news/local/local-woman-says-popular-antibiotic-killed-her-hus/njzwj/
February 2015 – Atlanta, Georgia: COX – http://www.wsbtv.com/videos/news/another-widow-says-medication-killed-her-husband/vDD6mw/
February 2015 – Miami, Florida: CBS – http://miami.cbslocal.com/2015/02/13/powerful-antibiotic-could-be-a-prescription-for-danger/
February 2015 – Sacramento, California: CBS – http://sacramento.cbslocal.com/2015/02/11/patients-say-popular-antibiotic-caused-devastating-side-effects/
February 2015 – Boston, Massachusetts: CBS – http://www.wsbtv.com/videos/news/channel-2-investigates-complaints-about-popular/vDDZZS/
February 2015 – Minneapolis, Minnesota: ABC –http://kstp.com/news/stories/S3718761.shtml?cat=1
February 2015 – Charlotte, North Carolina: NBC – http://www.wcnc.com/
February 2015 – Miami, Florida: CBS – http://miami.cbslocal.com/video/11172828-powerful-antibiotic-could-be-a-prescription-for-danger-pt-ii/
Documentary: Certain Adverse Effects
This amazing documentary and an absolute must watch.
Watch the whole Documentary – in 6 parts Certain Adverse Events on YouTube
PBS News: Certain Antibiotics Spur Widening Reports of Severe Side Effects
REPORT AIR DATE: June 16, 2011
See more from PBS NewsHour.
Bitter Pill – The Dangers of Fluoroquinolones – Video Some people claim a class of antibiotics called Fluoroquinolones has left them suffering from unusual and debilitating side effects. And they say, they were never properly warned. A 16×9 investigation into the potential risks of prescription drugs.
Forbes Article: Antibiotic Alert: The Drug The Doctor Ordered Could Cause Deadly Side Effects
Def Leppard Mourn the Death of Keyboardist Dick Decent.
The members of Def Leppard are mourning the passing of their friend and sometime collaborator Dick Decent, who had played with the band live as well as in a side group with Joe Elliot and Phil Collen.
Decent occasionally joined the group on stage at their U.K. dates to play keyboards on the song ‘When Love & Hate Collide,’ and he played with guitarist Collen and singer Elliott in their group Cybernauts in 2000 and 2001. According to his blog, the keyboardist had been sick since 2009, when he reacted badly to a round of antibiotics.
“Well… I’m not going to go into detail here, but in short I have been completely and totally F-CKED out of all existence by Ciprofloxacin and Ofloxacin,” Decent wrote. “I am too ill and in shock to post any more right now, but if you take anything away from this post, let it be an insistence on NOT TAKING ANY FLUOROQUINOLONE ANTIBIOTICS…. EVER… for ANY REASON.”
Def Leppard performed at a benefit to raise money for their friend last December. According to Brave Words, guitarist Vivian Campbell issued the following statement today:
“It is with great sadness that I heard of the passing of Dick Decent, super-talented musician, friend, and occasional keyboard player for Def Leppard. He was a young man and he should have lived a lot more life.Our time here is short and never fully in our control.
Live well and be good to each other.”
Source URL: http://ultimateclassicrock.com/def-leppard-mourn-keyboardist-dick-decent/
Dick Decent’s Blog: http://decentpie.blogspot.com/
Awareness and education resources
Drugwatch is an awareness group that maintains and updates a comprehensive database of dangerous drugs and devices with a considerable amount of information on each. They also broadcast Drugwatch Radio, where experts and real people discuss their experiences with drugs and devices.
http://www.drugwatch.com/cipro-levaquin-avelox/ (Levaquin Antibiotic Dangers)
http://www.drugwatch.com/drugs-and-devices/ (Dangerous Drug & Devices)
There are a number of online support groups and resources. Here are just a few to get you started. I will add more as my energy allows.
FACEBOOK OPEN GROUPS
Facebook Fluoroquinolone Antibiotic Toxicity Activism and Advocacy Page
FACEBOOK CLOSED GROUPS
Fluoroquinolone Toxicity Group
There are a few helpful blogs. Here are just a couple to get you started, I will add more as my energy allows.
Cipro Poisoning: Have You Been Floxed?
Down the Rabbit Hole and Into Chronic Illness: A Fluoroquinolone Toxicity Blog
Johnson & Johnson Levaquin Reaction Pain Art
Quick Health Notes, “Fluoroquinolones Can Cause Fibromyalgia”
Beyond the Mirror: The Scary Monster has Appeared
FLUOROKINOLONI ANTIBIOOTTIEN PITKÄAIKAISET HAITTAVAIKUTUKSET