Tag Archives: mitochondrial damage

Floxie Hope Email List and Free Ebook

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After 2.5 years, and more than 200 posts, I’m finally starting an email list for Floxie Hope. 🙂

If you sign up for the email list, you will get healing tips, links to interesting studies, updates on the recovery progress of those who have recovery stories on Floxie Hope, and more. You can sign up for the email list through this link – http://forms.aweber.com/form/15/753869915.htm – or through clicking the picture above.

You will also get a FREE EBOOK called HACKING FLUOROQUINOLONES if you sign up for the email list.

Hacking Fluoroquinolones describes the multiple levels of damage that fluoroquinolones do. Fluoroquinolones damage mitochondria, they leach minerals out of cells, they damage the microbiome, they damage the thyroid, and more. Information about each of these damage mechanisms is noted in Hacking Fluoroquinolones.

Thank you to all who sign up for the email list! I promise to share good information with you!

I won’t send you spam or share your email address with anyone else. As is the case with all legal email lists, you can unsubscribe at any time.

Many people already “follow” Floxie Hope. Thank you to all who do! This email list is different from “following” this site. When you follow Floxie Hope, you are sent an email whenever a post goes up. If you subscribe to the email list, you will receive the Hacking Fluoroquinolones ebook and follow-up emails with useful tips and information. You are welcome (and encouraged) to do both.

Thank you all for your support! I hope that Hacking Fluoroquinolones, and all the information on Floxie Hope, is helpful to you!

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Change the Warning Labels: Why it Matters

The warning label for Cipro/ciprofloxacin is already 43 pages long. It includes warnings about devastating adverse effects including irreversible peripheral neuropathy, destruction of weight-bearing joints, prolongation of the QT interval, seizures, severe hepatotoxicity, Stevens-Johnson syndrome, “psychotic reactions (that) have progressed to suicidal ideations/thoughts and self-injurious behavior such as attempted or completed suicide,” and more. Most of the symptoms of fluoroquinolone toxicity are already listed on the warning label. But when patients go to their doctors with symptoms of fluoroquinolone toxicity, they are often told that their reaction couldn’t be from the Cipro, Levaquin, Floxin or Avelox they took. To say that it’s frustrating that many doctors aren’t aware of the side-effects that ARE LISTED ON THE WARNING LABELS, is an understatement. It is shameful that the adverse effects listed on the warning labels aren’t known and quickly acknowledged by all medical professionals. It’s bad enough that many of those practicing medicine don’t know how to help people heal from fluoroquinolone toxicity, the fact that the symptoms that are listed on the warning labels aren’t often acknowledged, is horrible.

What’s the Point of the Warning Label?

It begs the question, if adverse-effects that are listed on the warning label aren’t being acknowledged, what is the point of the warning label?

One could argue that the only purpose of the warning label is to protect the pharmaceutical companies from being sued. After all, if you are hurt by a drug in a way that is listed on the warning label, most lawyers won’t take your case, and suing the drug companies for damage done is difficult to impossible.

Since patients are rarely given complete warning labels with their prescriptions for fluoroquinolones, and because the lengthy warning labels are still inadequate, and because the Learned Intermediary Doctrine makes it so that there are no requirements that patients even be informed about the consequences of taking prescription drugs, one could certainly argue that drug warning labels don’t protect consumers at all.

Citizen’s Petitions for Changing Fluoroquinolone Warning Labels

There are two citizen’s petitions that have been filed with the FDA asking for additional warnings to be added to the warning labels for Levaquin/levofloxacin (that would likely carry over to the other fluoroquinolones too). One of the petitions is for adding additional warnings of psychiatric adverse events, and the other is for adding “Possible Mitochondrial Toxicity” to the warning labels.

Since the existing warning labels are so inadequate for actually warning doctors or patients, and are actually counterproductive for patients seeking justice for the harm done to them, many people have asked, “What’s the point in adding anything to the warning label?” and they have asserted that adding more warnings to the labels isn’t what we should be aiming for.

In many ways, I agree with their assertions. If warning labels aren’t adequate or heeded, and if they actually get in the way of justice, we should be fighting for something other than more additions to the warning labels. We should be fighting for severe restrictions of these drugs, as well as true informed consent where all possible adverse effects are gone over with patients prior to administration of fluoroquinolones, similar to the restrictions put on Warfarin and Coumadin. We should fight for awareness of fluoroquinolone toxicity, so that doctors know about the possible harm they can do to patients with these drugs, so they can avoid doing that harm. We should fight for more research into fluoroquinolones so that the damage done by them can be more fully understood. We should fight for cures and assistance for those who have been hurt by fluoroquinolones. We should fight for justice, and more.

Many people and organizations ARE fighting for these things. Media outreach efforts are raising awareness and the doctors who are reached by these media reports are using fluoroquinolones more prudently. For example, it was reported that prescriptions for Levaquin/Levofloxacin dropped significantly after “Local woman says popular antibiotic killed her husband” aired and was shared more than 135k times on social media. The Quinolone Vigilance Foundation (QVF) works with scientists researching fluoroquinolones. Many people have written letters to their Representatives, the FDA and the AMA asking that stronger restrictions be put on fluoroquinolones. Several law firms are suing Bayer and Johnson & Johnson on behalf of fluoroquinolone victims. These things are all moves in the right direction.

Throwing a Punch at the Drug Companies

Receiving a positive response from the FDA to the Citizens’ Petitions is also a move in the right direction. Adding psychiatric adverse events and mitochondrial toxicity to the warning labels is actually a huge weapon for floxie advocates. Warning labels themselves may be useless, but during the time when a warning label has things added to it, they can be a great tool, and a big gun we can use against the pharmaceutical companies. The ONLY times lawyers are willing to take cases to sue the drug companies are when warning labels change. For example, when the fluoroquinolone warning labels were adjusted in August, 2013 to note that permanent peripheral neuropathy is a possible effect of fluoroquinolones, several law firms took cases of those who are suffering from peripheral neuropathy after taking fluoroquinolones. Before the warning label changed, they wouldn’t take the cases, because, appallingly, you can’t sue drug companies for hurting you, you can only sue them for “failure to warn” of the harm they’ll do. It’s a really stupid situation and stupid system. BUT, the time when warning labels change is the brief period of time in which you can sue the drug companies for “failure to warn” and it’s the brief period of time when we have the chance to fight the pharmaceutical companies. Opening this window is a good thing, and I support the Citizen’s Petitions because they are wonderful “window openers.” I hope that the FDA responds positively to them, and adds both psychiatric adverse events and “Possible Mitochondrial Toxicity” to the warning labels for all fluoroquinolones.

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If the window for justice can be opened by the Citizen’s Petitions, we may be able to throw a big punch that actually hurts Bayer and/or J&J. If psychiatric adverse events are added to the warning labels, ANYONE who has suffered from a psychiatric illness who had previously taken Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin or Floxin/ofloxacin can sue the drug companies that produce fluoroquinolones. That’s a lot of people who can, potentially, take a chunk of change out of Bayer’s and J&J’s pockets.

Mitochondrial toxicity is linked to many diseases, including all autoimmune diseases, neurodegenerative diseases, fibromyalgia, autism, CFS/ME, cancer, psychiatric illness, obesity, etc. Adding mitochondrial toxicity to fluoroquinolone warning labels opens the possibility for a HUGE punch to the pharmaceutical companies. If it is fully acknowledged that fluoroquinolones cause mitochondrial toxicity, anyone who comes down with a disease that is linked to mitochondrial toxicity can sue the manufacturer of the drug that hurt them. If everyone who got sick with a chronic disease who had previously taken a fluoroquinolone was able to sue Bayer or J&J, the drug companies would take note, and change may even occur.

It will be difficult for the FDA to claim that “possible mitochondrial toxicity” shouldn’t be added to fluoroquinolone warning labels. After all, it is stated IN THEIR DOCUMENT entitled, “Disabling Peripheral Neuropathy Associated with Systemic Fluoroquinolone Exposure,” that:

Ciprofloxacin has been found to affect mammalian topoisomerase II, especially in mitochondria. In vitro studies in drug-treated mammalian cells found that nalidixic acid and ciprofloxacin cause a loss of motichondrial DNA (mtDNA), resulting in a decrease of mitochondrial respiration and an arrest in cell growth. Further analysis found protein-linked double-stranded DNA breaks in the mtDNA from ciprofloxacin-treated cells, suggesting that ciprofloxacin was targeting topoisomerase II activity in the mitochondria.”

THEY acknowledge that fluoroquinolones deleteriously affect mitochondrial DNA. The least they could do is put that information on the warning labels.

Movement…. Hopefully in the Right Direction

I obviously have a lot of conflicting feelings about changing the fluoroquinolone warning labels. I wish that we, as citizens who have been hurt by these drugs, had more opportunities for enacting change. I also wish that the warning labels were meaningful documents that were heeded by doctors and patients alike, and that they didn’t primarily serve the pharmaceutical companies. I also wish that more victims of fluoroquinolones were able to gain justice BECAUSE THEY WERE WRONGLY HURT BY A PRESCRIPTION DRUG, rather than making them jump through legal loop-holes about “failure to warn.” Until those things change though, we need to use the tools and opportunities we have. If enacted, the Citizen’s Petitions give us an opportunity to throw a big punch.

I hope that the FDA changes the warning labels to reflect what is known about fluoroquinolones causing mitochondrial toxicity and psychiatric adverse events.  If the warning labels change, and the punch behind the mitochondrial toxicity and psychiatric adverse events is big enough, maybe real change will occur. We can hope.

 

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Petitioning the FDA – Comments Needed

Floxie friends, I have one thing that I am asking you to do today.  And please, if you decide to do it, do it sooner rather than later.  Please go to THIS LINK and make a comment about how fluoroquinolones have hurt you.  Let the FDA know that the current warning label for fluoroquinolones is insufficient.  Let the FDA know that their own findings of fluoroquinolone caused mitochondrial toxicity need to be noted on the warning labels of fluoroquinolones.

Again, here is the link for the citizens’ petition, filed with the FDA, where comments about how a fluoroquinolone hurt you can be made –

http://www.regulations.gov/#!docketDetail;D=FDA-2014-P-0856

If you do nothing else today, please, please make comments on this petition.

Thank you!

HERE is the petition that I am asking you to comment on.

The petition was submitted by Dr. Charles Bennett, M.D., Ph.D., M.P.P.  Dr. Bennett is with the Center for Medication Safety and Efficacy and the Southern Network on Adverse Reactions (SONAR).  The Quinolone Vigilance Foundation facilitated much of the work that went into the petition.  I thank both Dr. Bennett and his colleagues, and the Quinolone Vigilance Foundation for their work!

The petition is to add “Possible Mitochondrial Toxicity” to the Levaquin label.  In the Warnings and Precautions section of the Levaquin/levofloxacin label, it should say:

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.

That language, by the way, is directly from the FDA document, “Disabling Peripheral Neuropathy Associated with Systemic Fluoroquinolone Exposure.”  The folks at the FDA know that fluoroquinolones have been shown to be toxic to mitochondria, this petition is asking them to do something about it.

It is also requested in the petition that the following black box warning be added to the Levaquin/levofloxacin warning label:

WARNING: POSSIBLE MITOCHONDRIAL TOXICITY

Fluoroquinolones may cause Mitochondrial Toxicity. Mitochondrial Toxicity has been implicated in conditions such as peripheral neuropathy, hepatoxicity, glucose disturbances, phototoxicity, developmental disorders of the brain, optic neuropathy, neuropathic pain, hearing loss, muscle weakness, cardiomyopathy, lactic acidosis, Parkinson’s, Alzheimer’s, and amyotrophic lateral sclerosis (ALS).

Based on the severity of the effects of mitochondrial toxicity, it is being requested that:

  1. Levaquin label changes be made immediately.
  2. “Dear Doctor” letters be distributed regarding Levaquin label changes and requesting that physicians inform patients about the potential impact of “Possible Mitochondrial Toxicity” if they were previously prescribed this drug.

It is very important for all patients and medical professionals that this warning be added to the label of fluoroquinolones.  Please make your voice heard and support the petition with your comments.

THANK YOU!

 

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Dr. Robert Rountree’s Presentation about Mitochondria

I highly recommend that you watch this –

http://www.viddler.com/v/703896d9?secret=27514482

It’s a video of Dr. Robert Rountree giving a presentation about mitochondria. It’s fascinating!

Fluoroquinolones damage mitochondria. Here are my posts about fluoroquinolones damaging mitochondria –

There are more interesting posts about mitochondria on Hormones Matter, and probably some other sites too.

I try to make this complex information a bit more comprehensible than it is in journal article format, but if you want to read through some source articles on how fluoroquinolones damage mitochondria, here are some good ones:

Also, at roughly minute 26 of Dr. Rountree’s presentation, he mentions the link between cardiolipin damage and autoimmune diseases. Here is an article about how fluoroquinolones affect cardiolipin –

Journal of Medical Microbiology, “Comparison of the Effects of Subinhibitory Concentrations of Ciprofloxacin and Colistin on the Morphology of Cardiolipin Domains in Escherichia Coli Membranes

Dr. Rountree is brilliant and I don’t mean to be critical, but I think that some of the graphs toward the end of the presentation need to be re-drawn. From what I understand from reading the above articles, and others on mitochondria, the effects of ROS (reactive oxygen species – also known as oxidative stress), are not linear. When mitochondria experience a healthy amount of stress – through exercise, for example – there is an adaptive response. It is actually likely that the initial response of mitochondria to fluoroquinolones is an adaptive and healthy one – that could explain some of the experimental results that show a healthy or adaptive response of cells to fluoroquinolones. It is only after the threshold for damage is crossed that a maladaptive/unhealthy response begins. And once that maladaptive/unhealthy response begins, well, it’s bad news because the cell perpetuates damage on itself in the “vicious cycle” of mitochondrial damage. This article explains the phenomenon of a threshold for mitochondrial damage well –

Molecular Interventions, “Mechanisms of Pathogenesis in Drug Hepatoxicity Putting the Stress on Mitochondria

Can the cycle of cellular damage be stopped? I think so. If feeling good is an indicator of health, I know so. As always, I hope the same for all of you!

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Fluoroquinolone Antibiotics Damage Mitochondria – FDA Does Little

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The Pharmacovigilance folks at the FDA know that fluoroquinolones are damaging mitochondria.  Yet, they look the other way.  Adding a more severe warning about peripheral neuropathy to the warning label isn’t helpful.  People should know that they are increasing their risk of every chronic disease associated with mitochondrial damage and oxidative stress when they take a fluoroquinolone.  That would actually be helpful.

Here is the post, on Hormones Matter – http://www.hormonesmatter.com/fluoroquinolone-antibiotics-damage-mitochondria-fda-adds-warning/

 

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Can Antibiotics Induce Psychiatric Reactions?

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Fluoroquinolones cause mitochondrial damage and oxidative stress.  Mitochondrial damage and oxidative stress have been causally linked to all sorts of psychiatric disorders, including, but not limited to bipolar disorder, depression, attention deficit hyperactivity disorder, anxiety, etc.  Fluoroquinolones are bad for your brain.  Reactive oxygen species have hugely deleterious effects on all parts of the body and mind.

 

The full post can be found here –

https://www.hormonesmatter.com/antibiotics-psychiatric-reactions/

 

Thank you, as always, for reading and sharing information about the dangers of fluoroquinolones!

 

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The Fluoroquinolone Time-Bomb – answers in the Mitochondria

Adverse reactions to fluoroquinolones are often delayed and people can tolerate a certain number of fluoroquinolones before they experience an adverse reaction. Delayed reactions and tolerance thresholds are perplexing mysteries until you take a look at mitochondrial dysfunction. Both delayed reactions and tolerance thresholds are actually typical for disease states that are caused by mitochondrial dysfunction. More details on the matter in this post. As always, thank you for reading and sharing!

http://www.hormonesmatter.com/fluoroquinolone-time-bomb-mitochondria-damage/

 

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