Tag Archives: levofloxacin

Levaquin Production Stopped by J&J/Janssen Pharmaceuticals

Janssen Pharmaceuticals, part of Johnson & Johnson, has stopped production of (brand-name) Levaquin, according to the article, “Drug maker stopped making popular antibiotic Levaquin amid concerns about mental health side effects” published on the Indianapolis ABC affiliate RTV6 The Indy Channel. Janssen/J&J stopped producing both oral and IV Levaquin in December, 2017. The discontinuation of Levaquin production was confirmed by a Janssen/J&J spokesperson who stated, “The decision to discontinue LEVAQUIN was made due to the wide availability of alternative treatment options, and our focus on developing innovative medicines designed to address unmet medical patient needs.” Though that statement is BS propaganda, it is a direct confirmation from a Janssen Pharmaceuticals spokesperson that JANSSEN/JOHNSON & JOHNSON HAS DISCONTINUED PRODUCTION OF LEVAQUIN.

THIS IS REALLY BIG NEWS! IT’S HUGE! WHOA!

LEVAQUIN HAS BEEN REMOVED FROM THE MARKET!

Unfortunately, there is still plenty of levofloxacin (generic Levaquin, made by hundreds or thousands of generic pharmaceutical producers) on the market, and it is maiming (and killing) thousands of people each year. The fight against these drugs is far from over.

Still, the removal of brand-name LEVAQUIN from the market is a really big deal, and it’s something that we, as a community, should celebrate.

We did this. All the people who filed complaints with the FDA, who testified before the FDA, EMA, and other regulatory agencies, who reached out to the press and told their stories, who shared their story of pain and suffering brought on by fluoroquinolones, all the people who shared articles about fluoroquinolone toxicity, all the scientists who did research showing the harm done by fluoroquinolones, all the advocates, all the people in the floxie community, and all the people who listened–we did this! We screamed loudly enough that people listened. Our efforts made a difference, and Janssen Pharmaceuticals has stopped making Levaquin.

“Never doubt that a small group of committed people can change the world. Indeed it is the only thing that ever has.”—Margaret Mead

I never thought that one of the pharmaceutical giants that has made billions from fluroquinolones would stop making them. Janssen Pharmaceuticals and J&J are huge–they are behemoths–and I never thought that we could move or effect them. But we did.

The efforts of everyone in the “floxie” community contributed to this outcome. We–you–should be proud.

That is my optimistic take on things. We all have an optimistic side. We all have a pessimistic side too, and here’s the bad news.

Janssen decided to stop making Levaquin because, a) their market share was small because generic levofloxacin is cheaper and widely available (“’Levaquin was only about 1 percent of the market share, and 99 percent was the generic,’ said Bennett.”), and b) they were facing significant lawsuits, and to avoid liability for the drugs they created, they pulled them from the market.

Victims of pharmaceuticals can’t sue drug-makers for harming them, they can only sue for “failure to warn” of the dangers of the drugs. This is ridiculous – I can sue you for hitting me in the face with a sledgehammer even if you warn me that you’re going to do it and that it’s going to hurt – but pharmaceutical companies aren’t held to the same standards as you or me. It’s assumed that their deadly products are mainly good and that warning of the potential for bad effects is sufficient to wash their hands of liability and responsibility. On top of that, they don’t even have to directly warn YOU, they only have to say that they warned your doctor, the “learned intermediary” of the dangers of the drugs (or, at least they have to in theory – it’s assumed that doctors actually know what’s on the warning labels for pharmaceuticals… but most don’t). Both the “failure to warn” notion and the “learned intermediary” notions are crap, and I hate them, but they’re how the system is set up.

Because victims of pharmaceuticals can only sue for “failure to warn” the door for them to sue is only open when the drug warning labels change. Fluoroquinolone warning labels have undergone significant changes in recent years. In reverse-chronological order, the following warning label changes have been added to fluoroquinolone labels:

  • In July, 2018, fluoroquinolone warning labels were changed to note that, “Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects” – Drug Safety Communication
  • In July, 2016, fluoroquinolone warning labels were changed to note that, “FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together” – Drug Safety Communication
  • In May, 2016, fluoroquinolone warning labels were changed to note that, “FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects” – Drug Safety Communication
  • In August, 2013, fluoroquinolone warning labels were changed to note that, “FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection” – Drug Safety Communication
  • In July, 2008, fluoroquinolone warning labels were changed to note that, “FDA is notifying the makers of fluoroquinolone antimicrobial drugs for systemic use of the need to add a boxed warning to the prescribing information about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones and to develop a Medication Guide for patients.” – Drug Safety Communication

With each of these warning label changes, the door opened for people to sue Janssen and Johnson & Johnson for the harm that Levaquin did to them. (It should be noted that each of these warning labels changed because of advocacy done by the “floxie” community. We screamed, and, slowly, the FDA listened.) Some people did successfully sue the drug companies that hurt them–they gained some compensation and justice.

Perhaps it’s cynical, but it certainly seems more logical than the BS explanation the Janssen spokesperson gave (noted above) that the reason that Janssen Pharmaceuticals took Levaquin off the market was because they didn’t want to be held liable for the blood sugar level changes and the mental health side-effects of Levaquin. They weren’t making much money off it anyhow (because of generics taking the bulk of the market share), this warning label update opened up a new load of liability, and they did a cost-benefit analysis that led them to take it off the market.

All’s well that ends well, and they took Levaquin off the market, and that’s a good thing, right? Well, it’s more complicated than that.

Because of a stupid and asinine rule put in place by the FDA and a lousy decision of the Supreme Court, victims of generic pharmaceuticals cannot sue generic pharmaceutical manufacturers. It all goes back to the “failure to warn” rules noted above. The FDA says that only brand-name drug manufacturers can change drug warning labels, and since generic drug manufacturers can’t change the warning labels, they cannot be held responsible for what’s on the warning labels. This results in victims of generic drugs being unable to hold anyone responsible for the harm done to them by the drugs. There have been a couple cases where brand-name drug companies were held responsible for the harm done by generic drugs, but the precedent wasn’t set very solidly, and most attorneys in most states still aren’t taking cases of people who have been hurt by generic pharmaceuticals. Still, I think that Janssen and J&J saw the writing on the wall–that they could potentially be held responsible for all the Levaquin and levofloxacin-induced mental health side effects, permanently disabling side effects, permanent peripheral neuropathy, tendon tears, and more. So, they hedged their bets. Their legal team, I’m betting, will now argue that they can’t be held responsible for the harm done by levofloxacin because they don’t even make Levaquin any more, and how can they be held responsible for a product that they don’t even produce? My reply is that they can, and should, be held responsible for the drug that THEY CREATED. Johnson & Johnson created and held the patent on Levaquin for a long time. They made billions of dollars off of it. They can, and should, be held responsible for the effects of their creation. The generic drug companies should also be held responsible for the harm that their drugs do, and the FDA should be held responsible for their warning labels (and failure to warn the public about these incredibly dangerous drugs).

We pushed the FDA to change their warning labels. They did, and we should be proud of that. The warning label changes scared Janssen and J&J enough that they stopped production of Levaquin, and we should be proud of that too.

We should also be diligent about the consequences of the removal of Levaquin from the market, and we should continue to work for change in the legal/justice system so that it leans more toward justice for victims, and less toward corporate protection. It is horridly difficult for victims of pharmaceuticals to gain justice or compensation through the legal system as it is currently set up. Janssen pharmaceuticals just made a move to make it even more difficult for victims of Levaquin and levofloxacin to gain justice.

Know what they’re doing. Stay on top of them. Celebrate our victories, then come back to the battlefield fighting. As long as millions of prescriptions of levofloxacin are distributed each year, and thousands of people are maimed by the drugs, our fight isn’t over.

Can Floxies Drink Alcohol?

Many people have asked me if they can/should drink alcohol post-flox.

As with most things, the answer is – it depends, and everyone is different.

Some Floxies tolerate alcohol fine, while others don’t.

Alcohol is, of course, bad for you. It’s hard on the liver, and can lead to cirrhosis and alcoholic hepatitis. It burdens your liver’s detoxification abilities and hinders your ability to get rid of other toxins. Alcohol wreaks havoc on the gut microbiome, and can encourage candida growth. Alcohol weakens the immune system, and can make you more succeptible to other illnesses. I could go on and on because there are hundreds of articles about the harm that alcohol inflicts on the human body. No matter how many videos come out about tequila being a probiotic, or articles there are about wine containing resveritrol, alcohol is not a health elixir. It is not good for you.

HOWEVER, it is quite fun (IMO), and it even has some health benefits–it’s a painkiller and it reduces feelings of stress and anxiety. Alcohol has enough redeeming qualities that billions of people around the world, most of whom are aware of the negative effects of alcohol, consume it. I do, and so do many other floxies.

When I first got floxed, I stopped drinking for a while. My body was going hay-wire in every conceivable way, and I didn’t want to contribute to my problems by knowingly consuming a substance that is bad for me. I think that abstaining from alcohol during the acute phase of fluoroquinolone toxicity was the right thing for me to do.

Once my body stabilized (i.e. it stopped feeling like a bomb was going off in my body, and I even had some improved/normal days) I started having a drink every once in a while. Even though I could drink, I found that my tolerance for alcohol was greatly diminished. Before I got floxed I could handle three-ish drinks in an evening (and I thoroughly enjoyed drinking them). After getting floxed, my tolerance was one drink a night (that was barely enjoyable). I didn’t even want to drink more than that–I struggle to explain why, but I just felt done after 3/4 of a drink. Over time (I am now a bit over 5 years post-flox) my tolerance increased, and I can now comfortably have two alcoholic beverages in an evening. That’s plenty for me, in my personal opinion of how much I should/shouldn’t drink.

I never experienced a relapse in fluoroquinolone toxicity symptoms as a direct result of drinking alcohol, but other people have, and I encourage everyone who wants to drink post-flox to be very careful and cautious with alcohol consumption. Comments such as this one, from Bob (and the comment just above it when you click on the link, from Ann), are examples of alcohol triggering an increase in, or relapse of, fluoroquinolone toxicity symptoms:

After getting floxed I had relapses to alcohol which I only drank on vacation. I suspect this is due to severe kill off of gut flora. I am afraid to drink anymore.

This comment from Mark also notes that alcohol consumption can lead to fluoroquinolone toxicity symptom flares:

I cheated this weekend and drank alcohol/ate dairy. You know what? It flared up my cipro symptoms full force. Knee joints started cracking like crazy, achilles heal flare, etc. I’m convinced that we are all suffering an overgrowth of yeast and the faster we can get that under control, the healthier we will be.

Some people have a more moderate reaction to alcohol post-flox. This comment, from Ruth, is really interesting and insightful. Though she can drink alcohol without issue, she typically abstains:

I am able to drink again but my tolerance is greatly reduced. It won’t actually harm your gaba receptors because alcohol acts on gaba-b instead of gaba-a. I think it promotes healing.

When the alcohol downgrades the gaba-b subunit, I think the body makes repairs to some of the a subunits in order to put things back in balance.

I think when the FQ took out some of your gaba-a receptors your body gave you extra gaba-b receptors. This can make you a lot more receptive to the effects of alcohol. The b unit seems to be able to replace itself faster. That’s why alcohol withdrawal lasts a lot less long than benzodiazepine withdrawal. This is all just my theory. I have nothing to back it up with except my own experience.

Last year I got drunk at the Racine Zoo by accident. They hosted a teacher’s night and served spiked punches with no indication that they were alcoholic. I had what they had labeled as “Lesson Learned Lemonade.” I was thirsty so I slammed a big cup. At first I felt super relaxed and I thought that my nervous system must really be healing. Maybe it was that walk on the beach… and then I felt it. I knew it had been alcoholic. I ended up drunk off my ass, but not so bad that I couldn’t say “gamma amino butyric acid,” ha, ha. I got a brief relapse from that experience, of symptoms I had not had in a long time. After that ended my base line seemed higher.

So I think alcohol is not completely bad. However, it can devastate your gut microbiome, so I am very careful about it. I had a tiny tiny bit of Bailey’s at Christmas. I enjoyed it. Other than the holidays I abstain from alcohol for the sake of my healthy flora.

Although it won’t stop your nervous system from healing, remember that psych symptoms can also stem from an imbalance of healthy vs. unhealthy microbes. Alcohol can worsen that situation considerably so for the foreseeable future it is better to abstain. Farther down the road you will probably be able to have a beer now and then with no ill effects.

Some people have even found that alcohol has helped them. It is a pain reliever and relaxant. It reduces anxiety and stress – even the anxiety and stress that comes with getting poisoned by a pharmaceutical. Stress and anxiety reduction are crucial for healing from fluoroquinolone toxicity. Both Bronwen and Barbara noted that they felt better with moderate alcohol consumption.

Bronwen’s Comment:

As far as booze goes, I actually found one drink helped lessen my symptoms a bit when they were getting overwhelming in the evening – much to my surprise, but I have only ever read one other person that found the same thing – most find the opposite. Again, test yourself! I certainly could not have more than one drink. The liver is struggling along with the other organs, as the clearing house for toxins, so alcohol puts another burden on it.

Barbara’s Comment:

My saving grace is I am allowed wine 😁😁 hallelujah .I have been able to drink alcohol from the begining and in certain times when the pain was bad I swear it helped.

As you can see, reactions to alcohol post-flox vary considerably. So, what should your take-away from this post be? Should you drink alcohol, or not? I can’t answer that for you, because I have no idea how you respond to alcohol, or how much you enjoy consuming it. If alcohol isn’t your drug of choice, and you don’t particularly like it, don’t start drinking because some people have responded positively to its benefits. If you want to drink alcohol, it is, of course, best to do it in moderation. If you want to avoid all things that may trigger a relapse, or that are generally bad for the body, by all means, don’t drink. As with all advice for my floxie friends – it depends, everyone is different, and be careful.

 

Floxie Hope Podcast Episode 24 – PJ

PJ shared his journey through fluoroquinolone toxicity on Episode 24 of The Floxie Hope Podcast. Check it out!

https://itunes.apple.com/us/podcast/floxie-hope-podcast/id945226010

PJ was given IV levofloxacin/levaquin and flagyl in the hospital, and afterward he suffered from multiple severe side-effects including debilitating fatigue, peripheral neuropathy, body-wide numbness, pain, inflammation in all his joints, and more.

He has come a long way, and he is 80% recovered.

PJ is wonderfully insightful and inspirational. Please listen to, review, and share, this episode of The Floxie Hope Podcast. Thanks!!

 

 

 

 

Fluoroquinolones and Statins: A Recipe for Rhabdomyolysis

In May, 2017, WSB-TV 2 Atlanta aired the story, “Clark Howard says near-fatal disease possibly caused by popular antibiotic,” in which the story of how Clark Howard, a popular consumer expert and host of the nationally syndicated Clark Howard Show, was hurt by a combination of ciprofloxacin (a fluoroquinolone antibiotic) and generic Lipitor (a statin). Mr. Howard had a severe and life-threatening reaction to these drugs, and he is quoted in the story as saying, “I felt like death,” and “It was a struggle to walk five steps.” Mr. Howard was admitted to the hospital where he was diagnosed with rhabdomyolysis–a condition where muscles break down rapidly, causing severe strain on the kidneys and, potentially, death.

Both fluoroquinolones alone, and fluoroquinolones combined with statins, have been documented to cause rhabdomyolysis.

Here are some articles about fluoroquinolone-induced rhabdomyolysis:

Here is a news story about Chris Dannelly, who was killed after levofloxacin-induced rhabdomyolysis:

Additionally, here are some articles about fluoroquinolone plus statin induced rhabdomyolysis:

Both fluoroquinolones and statins are known to damage mitochondria, and they are both fluorinated drugs. They are also both widely prescribed–to millions of people annually–often concurrently.

In the article “Musculoskeletal Complications of Fluoroquinolones: Guidelines and Precautions for Usage in the Athletic Population” a description of the basic science behind fluoroquinolone-induced muscle damage (and rhabdomyolysis) is described. The following is a quote from “Musculoskeletal Complications of Fluoroquinolones: Guidelines and Precautions for Usage in the Athletic Population“:

Muscle: Basic Science

Although the etiology of fluoroquinolone-associated muscle disorders has yet to be fully elucidated, evidence supports a relationship with both latent myopathic disorders and the fluorine atom in fluoroquinolones. Despite no history of myopathy, an electromyogram (EMG) performed on a 54- year old woman with apparent ofloxacin-induced rhabdomyolysis demonstrated evidence of myopathy [85]. The patient’s myalgias and muscle weakness resolved upon discontinuation of ofloxacin. It is unknown whether the myopathic findings on EMG were related to the acute rhabdomyolysis or an underlying myopathy. In another case, a 33-year-old man thought to have norfloxacin-induced rhabdomyolysis was found to be susceptible to malignant hyperthermia by in vitro contracture tests [86], which raises the question of a possible link between the 2 conditions. His clinical complaints of myalgia and weakness and laboratory abnormalities resolved 6 months after discontinuing the norfloxacin. The researchers hypothesized that a similar muscle deficit may have accounted for the patient’s susceptibility to malignant hyperthermia and rhabdomyolysis induced by fluoroquinolones. Both malignant hyperthermia and fluoroquinolone-associated muscle disorders are thought to be triggered by a fluorine-containing compound [86]. To further investigate this possible connection, the same French investigators studied muscle function in 3 patients who presented with myalgia, tendinopathy, and arthralgia associated with fluoroquinolone exposure [87]. These results were compared with 3 patients exposed to fluoroquinolones who had no adverse events and 9 subjects with no known muscle disease who had not taken fluoroquinolones. Muscle contraction and metabolism were investigated through the use of histology, in vitro contracture tests, and 31P magnetic resonance spectroscopy (31P MRS). The 3 patients with fluoroquinolone-associated myalgia and weakness displayed similar metabolic abnormalities, whereas the 3 subjects exposed to fluoroquinolones with no adverse effects displayed normal metabolic profiles. These findings led the researchers to conclude that the adverse effects recorded in the 3 patients were related to a pre-existing muscular anomaly revealed by fluoroquinolone treatment. Further support for the hypothesis that fluorine may be the trigger for fluoroquinolone associated myopathy comes from the fact that no adverse muscular events have been reported with unfluorinated quinolones. In addition, steroid myopathy is thought to occur more frequently with fluorinated steroids (ie, dexamethasone and triamcinolone) than with nonfluorinated steroids (ie, prednisone or hydrocortisone) [88-90]. The researchers recommended that any patient experiencing myalgias associated with fluoroquinolone exposure should undergo noninvasive muscle metabolic testing with 31P MRS along with a subsequent muscle biopsy for histoenzymology and contracture tests if a metabolic disorder is found.

Muscle: Clinical Manifestations

A variety of muscle syndromes have been reported in association with fluoroquinolone use, ranging from mild myalgias to life-threatening rhabdomyolysis[78,85-87,91-95]. In fact, some investigators have proposed that myalgias may be the most common adverse effect of fluoroquinolone use [78]. Symptoms, which typically consist of diffuse muscle pain with or without weakness [86,87,91] and perhaps a predilection for proximal muscle groups [85,92], appear to manifest within 1 week after initiation of fluoroquinolone treatment [94] and often resolve within 1-4 weeks after discontinuation of the medication [78,86,91,92], although symptoms that persisted up to 6 months have been reported [86]. Statins may potentiate fluoroquinolone-associated myopathy (emphasis added) [91,92]. Furthermore, an association may exist between an underlying myopathic process and the development of myalgias and/or rhabdomyolysis after fluoroquinolone exposure, as previously discussed.

It is interesting that the authors of “Musculoskeletal Complications of Fluoroquinolones: Guidelines and Precautions for Usage in the Athletic Population” attribute myalgia and rhabdomyolysis to the fluorine atom that is added to quinolones to form fluoroquinolones. The toxicity of fluorine is often overlooked by researchers and “floxies” alike, in part because of the politics associated with assertions that fluorine and fluoride are toxic (they are). As the first sentence in the quote (“Although the etiology of fluoroquinolone-associated muscle disorders has yet to be fully elucidated”) notes though, the exact mechanism through which fluoroquinolones, statins, and fluoroquinolones and statins together, cause adverse reactions is not fully known.

What is known is that fluoroquinolones, and fluoroquinolones combined with statins, can cause rhabdomyolysis, and that rhabdomyolysis can be deadly.

If you are a “floxie” that is on statins, I highly recommend that you talk to your doctor about the case reports linked above and the possibility of rhabdomyolysis and other myalgias being induced by fluoroquinolones, statins, or both.

If you have existing myalgias, including fibromyalgia, I suggest that you take the quote above to your doctor and get off of all fluorinated drugs–as they have been shown to exacerbate myalgias.

I hope that the millions of people on statins, and their doctors, recognize that fluoroquinolones should not be given to people on statins because the two drugs combined can increase the likelihood of rhabdomyolysis and other myalgias.

I’m sorry that Mr. Howard was hurt by ciprofloxacin and generic Lipitor, but hopefully the publicity that his story is getting will serve as a warning for others.

 

Publicizing Fluoroquinolone Warnings

I have such mixed feelings about the FDA’s response to the November, 2015 Antimicrobial Drugs Advisory Committee meeting regarding fluoroquinolone safety. On one hand, I feel like they really did hear those who testified, and they not only listened, they responded in a way that showed that they listened. The FDA did what the Antimicrobial Drugs Advisory Committee recommended they do: they updated fluoroquinolone warnings to note that, “the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who have other treatment options.” They not only updated the warning labels, they updated the black-box warnings–the most severe warning a drug can have. I am truly grateful for the steps forward in acknowledging fluoroquinolone adverse-reactions, and I’m hopeful that the updated warning labels will lead physicians and patients to realize that fluoroquinolones are dangerous drugs with potentially devastating consequences.

I wonder though, what good is an updated warning label? In the post, Who Reads the Drug Warning Labels? I go over the problem of people not knowing what is on the warning labels. Are physicians going to read the updated warning labels? Are patients? Is anyone other than the “floxie” community going to realize that the warning labels have been changed?

I appreciate the action taken by the FDA–I really do–but are updated warning labels actually going to change anything? Will fewer people get injured and killed by fluoroquinolones? I certainly hope that a significant portion of doctors hear about the warning label changes, and stop prescribing fluoroquinolones, but, unfortunately, the FDA isn’t taking any major steps to make this happen.

The FDA has no plans to inform individual doctors about the recent warning label changes made to fluoroquinolone warning labels. Even though the black-box warnings, again–the most severe warning label a drug can receive, have been updated to note that fluoroquinolones are associated with disabling and potentially irreversible serious adverse reactions, the FDA is not going to tell doctors about the changes. No “dear doctor” letter will be issued by the FDA. They will not do a massive publicity campaign to let physicians or patients know that the warning labels have been updated. They know about the dangers of fluoroquinolones, and, in their own way, they acknowledge them, but they’re not proactively communicating what they know to patients or physicians.

Since the FDA isn’t going to issue a “dear doctor” letter, it will likely be helpful if we (the people in the fluoroquinolone toxicity community, and those who care about drug safety) give the information the FDA has released to our doctors, local hospitals, and media.

I encourage everyone reading this to please, please, please send this information (that is directly from the FDA) to your doctors, the media, your friends, your loved ones, and anyone else who you think may benefit from the information. People need to know how dangerous Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, and Factive/gemifloxacin are. In order for them to know how dangerous these drugs are, we need to tell them.

Please forward these FDA releases to those who need this information:

  1. 5/12/16 – Fluoroquinolone Antibacterial Drugs: Drug Safety Communication – FDA Advises Restricting Use for Certain Uncomplicated Infections
  2. 7/26/16 – FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects
  3. July, 2016 Drug Safety Labeling Changes

Since most people don’t actually click on links, I’m also going to copy and paste what the FDA notices said (feel free to share this post with anyone who needs the information too).

Fluoroquinolone Antibacterial Drugs: Drug Safety Communication – FDA Advises Restricting Use for Certain Uncomplicated Infections:

AUDIENCE: Internal Medicine, Family Practice, Pharmacy, Patient

ISSUE: FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.

An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.

As a result, FDA is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information. FDA is continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.

See the FDA Drug Safety Communication for a list of currently available FDA approved fluoroquinolones for systemic use.

BACKGROUND: The safety issues described in the Drug Safety Communication were also discussed at an FDA Advisory Committee meeting in November 2015.

RECOMMENDATION: Patients should contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion, and hallucinations. Patients should talk with your health care professional if you have any questions or concerns.

Health care professionals should stop systemic fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report

  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects:

SAFETY ANNOUNCEMENT

The U.S. Food and Drug Administration (FDA) approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, we revised the Boxed Warning, FDA’s strongest warning, to address these serious safety issues. We also added a new warning and updated other parts of the drug label, including the patient Medication Guide.

We have determined that fluoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risk of these serious side effects generally outweighs the benefits in these patients. For some serious bacterial infections the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option.

Patients must contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include unusual joint or tendon pain, muscle weakness, a “pins and needles” tingling or pricking sensation, numbness in the arms or legs, confusion, and hallucinations. Talk with your health care professional if you have any questions or concerns (see List of Serious Side Effects from Fluoroquinolones).

Health care professionals should not prescribe systemic fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risks outweigh the benefits in these patients. Stop fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course (see List of Currently Available FDA-approved Fluoroquinolones for Systemic Use).

Fluoroquinolones are antibiotic medicines that work by killing or stopping the growth of bacteria that can cause illness. They are FDA-approved to prevent or treat certain serious bacterial infections.

The labels of fluoroquinolone medicines already have a Boxed Warning for tendinitis, tendon rupture, and worsening of myasthenia gravis. The labels also include warnings about the risks of peripheral neuropathy and central nervous system effects. Other serious risks associated with fluoroquinolones are described in the labels, such as cardiac, dermatologic, and hypersensitivity reactions. After FDA’s 2013 review that led to the additional warning that peripheral neuropathy may be irreversible, FDA evaluated post-marketing reports* of apparently healthy patients who experienced disabling and potentially permanent side effects involving two or more body systems after being treated with a systemic fluoroquinolone (see Data Summary). We evaluated only reports submitted to FDA, so there are likely additional cases of which we are unaware. The side effects occurred within hours to weeks after starting the fluoroquinolone, and at the time we received the reports, the side effects had continued for an average of 14 months to as long as 9 years after stopping the medicines. Several cases reported that some side effects stopped or improved after discontinuation of the medicine; others reported the side effects worsened or continued.

We previously communicated about these safety issues associated with fluoroquinolones in May 2016. Additional communications about related safety issues associated with fluoroquinolones occurred in August 2013 (peripheral neuropathy) and July 2008 (tendinitis and tendon rupture). The safety issues described in this Drug Safety Communication were also discussed at an FDA Advisory Committee meeting in November 2015.

In addition to updating information in the Boxed Warning, we are also including information about these safety issues in the Warnings and Precautions section of the label. The Indications and Usage section contains new limitation-of-use statements to reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI). The patient Medication Guide that is required to be given to the patient with each fluoroquinolone prescription describes the safety issues associated with these medicines. We are continuing to assess safety issues with fluoroquinolones as part of FDA’s usual ongoing review of drugs and will update the public if additional actions are needed.

We urge health care professionals and patients to report side effects involving fluoroquinolone antibacterials and other drugs to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

ADDITIONAL INFORMATION FOR PATIENTS

  • Fluoroquinolone antibiotic medicines are associated with disabling and potentially permanent serious side effects that can occur together in the same patient and should not be used to treat certain uncomplicated infections. These uncomplicated infections include acute bacterial sinusitis (ABS), acute worsening of bacterial chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI).
  • These side effects can involve the tendons, muscles, joints, nerves, and central nervous system, and can occur within hours to weeks after starting a fluoroquinolone medicine.
  • FDA has updated the Boxed Warning in the labels, added new warnings, and has revised the patient Medication Guide of all fluoroquinolone antibiotics.
  • Contact your health care professional immediately if you experience any serious side effects while you are taking your fluoroquinolone medicine.
  • Before starting a new fluoroquinolone medicine, inform your health care professional if you have previously experienced any serious side effects with another antibiotic.
  • Serious side effects involving the tendons, muscles, joints and nerves include:
    • Swelling or inflammation of the tendons
    • Tendon rupture
    • Tingling or pricking sensation (“pins and needles”)
    • Numbness in arms or legs
    • Muscle pain
    • Joint pain
    • Joint swelling
  • Serious central nervous system side effects include:
    • Depression
    • Hallucinations
    • Suicidal thoughts
    • Confusion
    • Anxiety
  • Other side effects include:
    • Abnormally rapid or irregular heart beat
    • Ringing or buzzing in the ears
    • Vision problems
    • Skin rash
    • Sensitivity of skin to sunlight
    • Headache
    • Trouble falling asleep
    • Fatigue
  • Read the patient Medication Guide you receive with your fluoroquinolone antibiotic prescriptions, which explains the benefits and risks of the medicine.
  • Talk to your health care professional if you have questions or concerns about fluoroquinolone antibiotic medicines.
  • We communicated safety information associated with fluoroquinolones in May 2016, August 2013, andJuly 2008.
  • Report side effects from a fluoroquinolone or any drug to your health care professional and the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of this page.

ADDITIONAL INFORMATION FOR HEALTH CARE PROFESSIONALS

  • FDA has approved label changes that reserve the use of fluoroquinolone antibacterial medicines when treating acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) for patients who do not have alternative treatment options.

  • FDA has also updated the Boxed Warning and the Warnings and Precautions sections of the labels and revised the patient Medication Guide of the fluoroquinolone drug class to describe the serious risk of multiple disabling and potentially irreversible adverse reactions that can occur together.

  • These adverse reactions primarily include tendinitis and tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy, and central nervous system effects.

  • The adverse reactions can occur within hours to weeks after starting treatment with a fluoroquinolone medicine.

  • Discontinue the fluoroquinolone medicine immediately at the first signs or symptoms of any serious adverse reaction.

  • Avoid fluoroquinolones in patients who have previously experienced serious adverse reactions associated with fluoroquinolones.

  • Serious Adverse reactions of the musculoskeletal system and peripheral nervous system include:

    • Tendinitis/Tendon rupture

    • Muscle pain

    • Muscle weakness

    • Joint pain

    • Joint swelling

    • Peripheral Neuropathy

    • Serious Central nervous system effects include:

      • Psychosis
      • Anxiety
      •  Insomnia
      • Depression
      • Hallucinations
      • Suicidal thoughts
      • Confusion
    • Other adverse reactions include:

      • Exacerbation of myasthenia gravis
      • Prolongation of the QT interval
      • Hypersensitivity reactions/anaphylaxis
      • Photosensitivity/phototoxicity
      • Blood glucose disturbances
      • Clostridium difficile-associated diarrhea
    • Encourage patients to read the Medication Guide that they receive with their fluoroquinolone prescriptions.

    • FDA convened a public advisory committee meeting in November 2015 to discuss the risks and benefits of fluoroquinolone antibacterial medicines for the treatment of ABS, ABECB, and uncomplicated UTI. We also communicated safety information associated with fluoroquinolones in May 2016, August 2013, and July 2008.

    • Report adverse reactions involving a fluoroquinolone or any drug to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of this page.

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Levaquin/levofloxacin Warning Label Changes (Please see July, 2016 Drug Safety Labeling Changes for the other fluoroquinolone label changes:

BOX WARNING (revised)

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS

  • Fluoroquinolones, including LEVAQUIN®, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including:
    • Tendinitis and tendon rupture
    • Peripheral neuropathy
    • Central nervous system effects
  • Discontinue LEVAQUIN immediately and avoid the use of fluoroquinolones, including LEVAQUIN, in patients who experience any of these serious adverse reactions. Fluoroquinolones, including LEVAQUIN, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid LEVAQUIN in patients with known history of myasthenia gravis.
  • Because fluoroquinolones, including LEVAQUIN, have been associated with serious adverse reactions, reserve LEVAQUIN for use in patients who have no alternative treatment options for the following indications:
    • Acute exacerbation of chronic bronchitis
    • Acute uncomplicated cystitis
    • Acute sinusitis

WARNINGS AND PRECAUTIONS

Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects (addition)
  • Fluoroquinolones, including LEVAQUIN, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting LEVAQUIN. Patients of any age or without pre-existing risk factors have experienced these adverse reactions.
  • Discontinue LEVAQUIN immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including LEVAQUIN, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.
Tendinitis and Tendon Rupture replaces Tendinopathy
  • Fluoroquinolones, including LEVAQUIN, have been associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons. Tendinitis or tendon rupture can occur, within hours or days of starting LEVAQUIN, or as long as several months after completion of fluoroquinolone therapy… Tendinitis and tendon rupture can occur bilaterally.
  • The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Discontinue LEVAQUIN immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Avoid fluoroquinolones, including LEVAQUIN, in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture.
Peripheral Neuropathy (new sentences added)
  • Fluoroquinolones, including LEVAQUIN, have been associated with an increased risk of peripheral neuropathy. Cases of sensory…
  • …minimize the development of an irreversible condition…Avoid fluoroquinolones, including LEVAQUIN, in patients who have previously experienced peripheral neuropathy.

ADVERSE REACTIONS

  • The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:
    • Disabling and Potentially Irreversible Serious Adverse Reactions (addition)
    • Tendinitis and Tendon Rupture (replaces Tendon Effects)

PATIENT COUNSELING INFORMATION

Serious Adverse Reactions
  • Advise patients to stop taking LEVAQUIN if they experience an adverse reaction and to call their healthcare provider for advice on completing the full course of treatment with another antibacterial drug. Inform patients of the following serious adverse reactions that have been associated with LEVAQUIN or other fluoroquinolone use:
  • Disabling and potentially irreversible serious adverse reactions that may occur together: Inform patients that disabling and potentially irreversible serious adverse reactions, including tendinitis and tendon rupture, peripheral neuropathies, and central nervous system effects, have been associated with use of LEVAQUIN and may occur together in the same patient. Inform patients to stop taking LEVAQUIN immediately if they experience an adverse reaction and to call their healthcare provider. (addition)
  • Tendinitis and tendon rupture replaces Tendon Disorders

MEDICATION GUIDE

What is the most important information I should know about LEVAQUIN?

Tendon rupture or swelling of the tendon (tendinitis).

  • Stop taking LEVAQUIN immediately and get medical help right away…
  • Worsening of myasthenia gravis (a problem that causes muscle weakness). Tell your healthcare provider if you have a history of myasthenia gravis before you start taking LEVAQUIN. (addition)

What is LEVAQUIN?

  • LEVAQUIN should not be used in patients with acute exacerbation of chronic bronchitis, acute uncomplicated cystitis, and sinus infections, if there are other treatment options available.
  • LEVAQUIN should not be used as the first choice of antibacterial medicine to treat lower respiratory tract infections cause by a certain type of bacterial called Streptococcus pneumoniae.

Before you take LEVAQUIN, tell your healthcare provider if you:

  • have a disease that causes muscle weakness (myasthenia gravis); LEVAQUIN should not be used in patients who have a known history of myasthenia gravis.
  • have nerve problems; LEVAQUIN should not be used in patients who have a history of a nerve problem called peripheral neuropathy

How should I take LEVAQUIN?

Do not skip any doses of LEVAQUIN, or stop taking it, even if you begin to feel better, until you finish your prescribed treatment unless:

  • you have nerve problems. See “What is the most important information I should know about LEVAQUIN?”

  • you have central nervous system problems. See “What is the most important information I should know about LEVAQUIN?”

     

All help in spreading the word about these FDA warnings will be greatly appreciated!

 

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Fluoroquinolones Removed From the Market

Several fluoroquinolones have been removed from the market because they caused acute toxicity and death. The fluoroquinolones that have been removed from the market are not terribly different from the ones that remain on the market in terms of damage done or damage mechanisms.

Here are some of the fluoroquinolones that have been removed from the market:

Omniflox/temafloxacin

In 1992 the fluoroquinolone antibiotic Omniflox/temifloxacin was removed from the US market after causing three deaths.

To note the removal from the market, the FDA released the following statement:

            “The Food and Drug Administration today announced that Abbott Laboratories of Abbott Park, Ill., is voluntarily recalling the broad-spectrum anti-infective drug Omniflox (temafloxacin) tablets, and will halt all further distribution of the drug.

This action is being taken because of severe adverse events associated with the use of the drug that have been reported to the company and to FDA in the first three months of marketing.

Temafloxacin was approved in late January 1992 and marketed in mid-February.  Since that time there have been approximately 50 reports of serious adverse reactions, including three deaths.  There were several cases of severe low blood sugar, especially in very elderly patients with decreased kidney function.  Among the severe reactions there were a number of cases of an unusual complex of adverse reactions consisting of hemolitic anemia (destruction of red blood cells) and other blood cell abnormalities.”

The fluoroquinolones that remain on the market also impair kidney function. From the 2013 Science Daily article, Risk of kidney disease doubled with use of fluoroquinolone antibiotics, “The risk of acute kidney disease is doubled for people taking oral fluoroquinolone antibiotics, according to a new study.” The article pointed out that the risk of acute kidney disease was increased for patients taking cipro/ciprofloxacin, levaquin/levofloxacin, avelox/moxifloxacin and floxin/ofloxacin – fluoroquinolones that remain on the market today.

The fluoroquinolones that remain on the market also cause blood-sugar abnormalities, including severe low blood sugar. A large 2013 study out of Taiwan looked at more than 78,000 patient records and found that, “The researchers found that patients with diabetes who had taken fluoroquinolone antibiotics had higher rates of both hyperglycemia and hypoglycemia compared with those who had taken macrolide antibiotics.” (source) Additionally, in the article, Fluoroquinolone antibiotics and type 2 diabetes mellitus, it is noted that, “Exposure to fluoroquinolone antibiotics is postulated as a risk factor for subsequent development of type 2 diabetes. It is hypothesized that fluoroquinolones induce an intracellular magnesium deficit that can lead to insulin resistance.”

Raxar/grepafloxacin

Raxar/grepafloxacin was removed from the worldwide market in 1999. The FDA withdrawal notice stated:

RAXAR is a fluoroquinolone antibiotic indicated for the treatment of infections caused by strains of bacteria susceptible to grepafloxacin in the following diseases: community-acquired pneumonia; acute bacterial exacerbations of chronic bronchitis; uncomplicated gonorrhea (urethral in males and endocervical and rectal in females); non-gonococcal urethritis and cervicitis.

Glaxo Wellcome has recently concluded an extensive review of the safety of RAXAR and determined that due to an effect of RAXAR on cardiac repolarization, manifested as QT interval prolongation on the electrocardiogram (ECG), some patients may be at risk of a very rare but serious ventricular arrhythmia known as torsade de pointes when treated with the product.

The warning label for Levaquin/levofloxacin (and the other fluoroquinolones that remain on the market) notes that:

“Prolongation of the QT interval and isolated cases of torsade de pointes have been reported. Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval.”

Additionally, a study entitled “Azithromycin and Levofloxacin Use and Increased Risk of Cardiac Arrhythmia and Death” compared the risk of cardiac arrhythmia for U.S. Veterans taking amoxicillin, azithromycin and levofloxacin. The study concluded that:

“Compared with amoxicillin, azithromycin resulted in a statistically significant increase in mortality and arrhythmia risks on days 1 to 5, but not 6 to 10. Levofloxacin, which was predominantly dispensed for a minimum of 10 days, resulted in an increased risk throughout the 10-day period.”

Just like Raxar/grepafloxacin, the fluoroquinolones that are still on the market prolong the QT interval and cause torsade de pointes, which can lead to arrhythmia and death.

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Zagam/sparfloxacin

Zagam/Sparfloxacin was also removed from the market because it caused QT interval prolongation.

Zagam/Sparfloxacin also caused incidents of Stevens Johnson Syndrome:

“When a patient using  Zagam develops SJS or TEN after taking the fluoroquinolone antibiotic treatment, the individual’s topmost skin cells die and fall off. This leaves the deeper layers exposed and unprotected, making it likely for a patient to experience infection and scarring. The sensitive mucous membrane also becomes exposed when the upper layer of skin sloughs off, and may be prone to blistering.” (source)

Trovan/trovafloxacin

Trovan/Trovafloxacin was removed from the market because of its high potential for inducing serious, sometimes fatal liver damage (hepatotoxicity). The wiki entry for Trovafloxacin notes that:

In June 1999 the U.S. Food and Drug Administration advised doctors to limit the prescription of Trovan after it had been found “strongly associated” with 14 cases of acute liver failure and six deaths. The FDA had received over 100 reports of liver problems in people taking Trovan, which was at that time being prescribed at a rate of 300,000 patients per month in the United States. Two days later the Committee for Proprietary Medicinal Products recommended to the European Commission that marketing approval of Trovan be suspended for a year.

One of the best articles about the hepatotoxicity of Trovan/Trovofloxacin is Trovafloxacin, a fluoroquinolone antibiotic with hepatotoxic potential, causes mitochondrial peroxynitrite stress in a mouse model of underlying mitochondrial dysfunction. The article, Mechanisms of Pathogenesis in Drug Hepatotoxicity Putting the Stress on Mitochondria, by some of the same authors, is also enlightening. Liver damage, mitochondrial damage, and ROS overload/oxidative stress are all intricately connected. I highly recommend that you read the two articles linked to (but, man, they’re both really difficult articles). I suspect that both articles hold many of the keys to understanding all fluoroquinolone toxicity reactions. In the post, Article Breakdown – “Mechanisms of Pathogenesis in Drug Hepatotoxicity Putting the Stress on Mitochondria,” I go over some of the implications Mechanisms of Pathogenesis in Drug Hepatotoxicity Putting the Stress on Mitochondria has for floxies.

Interestingly, Trovan/Trovafloxacin has another area of shady history. In Kano, Nigeria, it was used in an improperly conducted trial on children with meningitis. Per the wiki entry for Trovafloxacin:

In 1996, during a meningitis epidemic in Kano, Nigeria, the drug was administered to approximately 200 [3] infected children. Eleven children died in the trial: five after taking Trovan and six after taking an older antibiotic used for comparison in the clinical trial. Others suffered blindness, deafness and brain damage, common sequalae of meningitis that have not been seen in patients treated with trovafloxacin for other infection types.[4][5][6] An investigation by the Washington Post concluded that Pfizer had administered the drug as part of an illegal clinical trial without authorization from the Nigerian government or consent from the children’s parents.[7] The case came to light in December 2000 as the result of an investigation by The Washington Post, and sparked significant public outcry. The most serious error was the falsification and backdating of an ethics approval leader by the lead investigator of the trial, Dr. Abdulhamid Isa Dutse. Dr. Dutse is now the chief medical officer of Aminu Kano Teaching Hospital. The result of the trial was that children treated with oral trovafloxacin had a 5% (5/100) mortality rate compared to a 6% (6/100) mortality rate with intramuscular ceftriaxone.

Between 2002 and 2005 the victims of the Trovan tests in Nigeria filed a series of unsuccessful lawsuits in the United States. However, in January 2009, the United States Court of Appeals for the Second Circuit ruled that the Nigerian victims and their families were entitled to bring suit against Pfizer in the United States under the Alien Tort Statute. A US$75 million settlement with the State of Kano was reached July 30, 2009.[8] Additionally two lawsuits also remain pending in New York, United States.[8] According to Wikileaked US embassy cables, Pfizer’s country manager admitted that “Pfizer had hired investigators to uncover corruption links to federal attorney general Michael Aondoakaa to expose him and put pressure on him to drop the federal cases.”[9]

Additional information about the Kano trial can be found in The Guardian article, Pfizer pays out to Nigerian families of meningitis drug trial victims.

Tequin/gatifloxacin

Tequin/Gatifloxacin was pulled from the market because it caused severe blood sugar reactions such as hyperglycemia and hypoglycemia.

The New England Journal of Medicine article, Outpatient Gatifloxacin Therapy and Dysglycemia in Older Adults, noted that:

“Between April 2002 and March 2004, we identified 788 patients treated for hypoglycemia within 30 days after antibiotic therapy. As compared with macrolide antibiotics, gatifloxacin was associated with an increased risk of hypoglycemia (adjusted odds ratio, 4.3; 95 percent confidence interval, 2.9 to 6.3). Levofloxacin was also associated with a slightly increased risk (adjusted odds ratio, 1.5; 95 percent confidence interval, 1.2 to 2.0), but no such risk was seen with moxifloxacin, ciprofloxacin, or cephalosporins. We then identified 470 patients treated for hyperglycemia within 30 days after antibiotic therapy. As compared with macrolides, gatifloxacin was associated with a considerably increased risk of hyperglycemia (adjusted odds ratio, 16.7; 95 percent confidence interval, 10.4 to 26.8), but no risk was noted with the other antibiotics. Risks were similar in the two studies regardless of the presence or absence of diabetes.”

A more recent study, that looked at a larger population than the NEJM study, Risk of Severe Dysglycemia Among Diabetic Patients Receiving Levofloxacin, Ciprofloxacin, or Moxifloxacin in Taiwan, found that all of the fluoroquinolones on the market increased the likelihood of both hyper and hypo glycemia in diabetic patients:

“A total of 78 433 diabetic patients receiving the antibiotics of interest were included in the study. The absolute risk of hyperglycemia per 1000 persons was 6.9 for moxifloxacin and 1.6 for macrolides. In contrast, the risk of hypoglycemia was 10.0 for moxifloxacin and 3.7 for macrolides. The adjusted odds ratios (AORs) and 95% confidence intervals (CIs) of levofloxacin, ciprofloxacin, and moxifloxacin compared with macrolides were 1.75 (1.12–2.73), 1.87 (1.20–2.93), and 2.48 (1.50–4.12), respectively, for hyperglycemia and 1.79 (1.33–2.42), 1.46 (1.07–2.00), and 2.13 (1.44–3.14), respectively, for hypoglycemia. Patients taking moxifloxacin faced a significantly higher risk of hypoglycemia than those receiving ciprofloxacin. A significant increase in the risk of hypoglycemia was also observed among patients receiving moxifloxacin concomitantly with insulin (AOR, 2.28; 95% CI, 1.22–4.24).”

As mentioned in the Temafloxacin section of this post, fluoroquinolone use has been linked to development of diabetes. Given that all fluoroquinolones cause blood-sugar dysregulation, and two fluoroquinolones have been removed from the market because they caused severe blood-sugar fluctuations, perhaps fluoroquinolones are behind the dramatic increase in both type 1 and type 2 diabetes over the last 30 years. It is a hypothesis that should certainly be looked into.

Conclusion

I struggle with whether or not I think all fluoroquinolones should be taken off the market. Even though I know that they are all dangerous, and sometimes even deadly, drugs, I also know that we are running out of antibiotics in our arsenal and that sometimes dangerous drugs are necessary in order to save a person’s life. I tend to think that Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin, and the other fluoroquinolones, should be severely restricted, and that there should be strict procedures followed when they are prescribed so that it is ensured that they will only be used in life-or-death situations where informed consent is given.

When looking at the fluoroquinolones that have been removed from the market, it always strikes me that they were removed from the market quickly after just a few deaths or a few studies that showed that they are dangerous drugs. The fluoroquinolones that remain on the market (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin) have also killed people. According to an FDA review with the subject, “Pediatric Exclusivity Postmarketing Adverse Event Review,” between 12/20/1996 and 08/27/2008, 924 people were killed by Levaquin/levofloxacin, including three children. The figures for Cipro/ciprofloxacin, Avelox/moxifloxacin, and Floxin/ofloxacin are similar. So, why do Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin have such staying power? Why are they still on the market when Temafloxacin/Omniflox, Raxar/grepafloxacin, Zagam /Sparfloxacin, Trovan/Trovafloxacin, and Tequin/Gatifloxacin have been removed from the market? I don’t know the answers to those questions–I wish I did. It seems to me that the FDA used to be a stronger, more independent, more effective organization than it is today, and that it used to actually pull dangerous drugs from the market.

Rather than removing dangerous fluoroquinolones from the market, or even imposing meaningful restrictions on the fluoroquinolones that remain on the market, the FDA has instead chosen to increase the size of the fluoroquinolone warning labels. As I have noted before, changed warning labels open the door for lawsuits and that’s a good thing, but it is overall a useless move that is devoid of real change. Not enough doctors or patients read warning labels, and they are a lousy way to communicate the real risks of pharmaceuticals.

The fluoroquinolones that remain on the market are not significantly different from the fluoroquinolones that have been removed from the market. Updating warning labels isn’t keeping people from getting hurt by these dangerous drugs. I understand hesitation to remove them from the market completely, but there should be significant restrictions put on their use. Right now they are not being used prudently or appropriately. That must change. Too many people are being hurt by these dangerous drugs.

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Can Fluoroquinolones Activate Mast Cells?

What is the connection between fluoroquinolone toxicity and mast cell activation / histamine intolerance? Can fluoroquinolones trigger mast cell activation and histamine intolerance?

The symptoms of mast cell activation are similar to those of fluoroquinolone toxicity. According to Mastocytosis Society Canada, the symptoms of mast cell activation are:

skin lesions or sores, skin rash, spots, redness, hives, persistent fatigue, itching, flushing & severe sweating, joint, bone pain, headaches, tachycardia (racing heartrate), eyes tearing/dry, eye pain, persistent body/tissue pain, difficulty exercising, vertigo, episodes of low body temperature, unexplained Vitamin B12 deficiency, scents/odors/chemical reactions, difficult menses (females), numbness & tingling in face and extremities, skin feels on fire, unexplained anxiety, sudden drops in blood pressure, fainting, persistent diarrhea, vomiting, unexplained weight loss, cognitive impairment, sinus problems, chest pain, vision problems, hair loss, mouth sores, nausea, swelling & inflammation, odd reactions to insect stings, anesthesia difficulties, anemia, thyroid problems, decreased bone density, unexplained weakness, shortness of breath, sunlight sensitivity, temperature (hot/cold) sensitivity, difficulty with foods, drinks, anaphylactoid reactions, anaphylaxis, gastrointestinal pain, bloating, unexplained medication reactions, enlarged liver/spleen, liver/spleen/bladder/kidney pain, enlarged lymph nodes, frequent urination, recurring infections, neuropathic pain, constipation, iron deficiency, unexplained bruising, bleeding, malabsorption, intermittent tinnitus or hearing problems.

That’s a pretty comprehensive list of fluoroquinolone toxicity symptoms too. (Though, as I discussed with Dr. Wahls in episode 14 of The Floxie Hope Podcast, all of the multi-symptom, chronic diseases of modernity have more in common with each other than they don’t, and should probably all just be categorized as cellular dysfunction disorders and treated similarly.)

Several floxies who have been able to get a diagnosis from a doctor have come back with a diagnosis of mast cell activation, or a disease that is related to mast cells. For example, one floxie friend’s doctors have diagnosed him with eosinophilia, a disorder that is related to mast cells and histamine intolerance. Other floxies have been diagnosed as histamine intolerant, and instructed to go on a low-histamine diet. As noted above, many floxies have symptoms of mastocytosis, and it is possible that fluoroquinolones activate mast cells and trigger mastocytosis.

Mast cell disorders are considered to be rare, but, according to Mastocytosis Society Canada, “escalation in the prevalence of these patients worldwide has resulted in a flurry of medical research ongoing in numerous countries. This indicates that these disorders may not be rare, but rather have been commonly misidentified and unfortunately for patients worldwide, commonly undiagnosed. Since approximately 2005, every year there are new theories, classifications, and adjustments to the mastocytosis definitions due to escalation of patients presenting with these disorders worldwide.”

I found the following information connecting fluoroquinolones and mast cell activation / mastocytosis:

  • From the International Journal of Tissue Reaction’s article, Effect of levofloxacin and ciprofloxacin injection on permeability of the tail vein in mice and skin microvasculature in rats, “These results suggest that LVFX and CPFX increase vascular permeability through the induction of histamine release from mast cells in rodents.” (LVFX is levofloxacin and CPFX is ciprofloxacin.)
  • From the Journal of Pharmacy and Pharmacology’s article, Characterization of Histamine Release Induced by Fluoroquinolone Antibacterial Agents In-vivo and In-vitro, “Intravenous injection of levofloxacin and ciprofloxacin at 1–10 mg kg−1 produced dose-related elevations in plasma histamine level in anaesthetized dogs. In contrast, levofloxacin was devoid of plasma histamine increment in anaesthetized rats at 100 mg kg−1, whereas ciprofloxacin at the same dose caused endogenous histamine release. Levofloxacin and ciprofloxacin induced non-cytotoxic secretion of histamine from all mast cells tested in a concentration-dependent manner, whereas rat skin and peritoneal mast cells were thirty- to one-hundred-times less sensitive to the effect of fluoroquinolones as compared with the canine skin mast cells.” Note that in studies beagle puppies have been made lame by fluoroquinolones.
  • From the Archives of Toxicology’s article, Differential response of mast cells separated from various organs and basophils of dogs to the fluoroquinolone antimicrobial levofloxacin, “Histamine releases induced by the fluoroquinolone antimicrobial levofloxacin (LVFX) were investigated using mast cells separated from various organs and peripheral basophils of dogs, being the most susceptible species to quinolone derivatives, in both in vivo and in vitro systems. An intravenous infusion of LVFX at 30 mg/kg over a 30-min period produced endogenous histamine release from 5 min, and a maximum at 30 min, in which the plasma LVFX concentration was approximately 50 µM. A close correlation (r=0.87, n=20) between histamine and LVFX concentrations in plasma during the infusion was observed. In the in vitro study, LVFX at 30 µM or more caused histamine release from mast cells separated from the liver and skin, but not from the gastric mucosa, lung, and peripheral basophils. More exactly, the liver mast cells were most susceptible to LVFX among the organs tested. On the other hand, compound 48/80, a prototype histamine liberator, elicited the histamine release from the liver or skin mast cells at 10 µg/ml, and the calcium ionophore A23187 at 1 µM exhibited the histamine release from the mast cells derived from all organs examined. Histochemical analysis revealed that the liver and skin mast cells had positive reaction for both alcian blue and safranin staining, but the gastric mucosa and lung mast cells were only positive for alcian blue staining, indicating that LVFX preferably activated the connective tissue-type mast cells rather than the mucosal-type mast cells. The degranulation of the liver and skin mast cells brought about by either LVFX or compound 48/80, unlike the calcium ionophore A23187, was blocked by pretreatment with pertussis toxin, suggesting the involvement of pertussis toxin-sensitive G proteins. The results obtained from the canine experiments strongly suggest that LVFX induces histamine release from the connective tissue-type mast cells distributed mainly in the liver, somewhat in the cutaneous tissue, through the activation of pertussis toxin-sensitive G proteins.”

The articles noted above are all from animal studies, not human studies, but they show that fluoroquinolones can activate mast cells and histamine release in mammals, and it’s reasonable to think that they may do the same things to humans that they do to dogs. Also, the similarity between fluoroquinolone toxicity symptoms and mastocytosis symptoms, though not a smoking gun, indicate that further studies of the affects of fluoroquinolones on mast cells should be done.

A few good resources for people with mastocytosis, and it’s possible that floxies are in that category, are:

  1. Dr. Theoharides web site
  2. Mastocytosis Society Canada web site
  3. The Low Histamine Chef web site
  4. Alison Vickery’s web site

I suspect that mast cells are profoundly affected by fluoroquinolones and that mast cell activation is a big part of fluoroquinolone toxicity. The potential options, and mechanisms for fluoroquinolone toxicity, are mind-boggling. Add mast cell activation to the list.

 

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Fluoroquinolones and Mercury Poisoning

I recently received a message from a floxie friend that raised an interesting question. My friend asked:

Have you ever heard that FQ antibiotics can release stored toxins like mercury into the body? It has been two years since Cipro for me, and one month ago they found out I am highly mercury poisoned. But before I took Cipro, I was okay. The doctors are guessing that I have been mercury poisoned for a long time but somehow it is showing up in my blood now. Since the symptoms of Cipro toxicity and mercury poisoning are about the same, I’m wondering if they’re related.”

Over the years, several people have raised the question of whether or not fluoroquinolone toxicity is related to mercury poisoning, but I hadn’t heard of test-documented increases in mercury levels after taking fluoroquinolones until my friend sent me the message above.

The symptoms of mercury poisoning are similar to those of fluoroquinolone toxicity. The symptoms of mercury poisoning are:

skin rashes and dermatitis; mood swings; memory loss; mental disturbances; muscle weakness; nervousness, irritability, and other emotional changes; insomnia; headache; abnormal sensations; muscle twitching; tremors; decreased cognitive functions; peripheral neuropathy and more.

According to Dr. Thomas Nissen, “ Symptoms of mercury toxicity are many and varied, since mercury can both reach and affect nearly every cell in the body! Systemic (overall) effects can occur for this reason. The particular symptoms you experience first depend on your own genetic weakest links and on other toxic suppressors.”

Similarity of symptoms does not necessarily mean that two disorders are one in the same. For example, Chronic Lyme Disease and AIDS have similar symptoms, but that doesn’t mean they’re the same diseases. But it’s still interesting to explore the possibility of fluoroquinolone toxicity being related to mercury poisoning.

I searched for journal articles about the effects of quinolones on mercury. Unfortunately, I didn’t find much information. Most of the information I have is anecdotal and stems from me attempting to understand fluoroquinolone toxicity (with zero background in biochemistry), so please take this information for what it’s worth.

Fluoroquinolones have been documented to chelate magnesium and iron from cells. I wonder if mercury in the body is bound by these minerals, and then gets released into the body when the fluoroquinolone chelates the necessary mineral from the body (or when the quinolone binds to the mineral, stealing it from whatever it’s currently bound to).

Dr. Nissen points out that mercury can displace other minerals in the body, and that mineral displacement can cause serious health problems:

Replacement reactions, also called fight for site, occur when mercury (usually with a +2 charge) grabs the biological spaces which should be filled by necessary minerals. Symptoms that can be caused by a deficiency of minerals displaced by mercury include:

  • Magnesium: irregular heartbeat, receding gums
  • Iron: anemia
  • Copper: anemia, thyroid dysfunction, impaired digestion
  • Zinc: anorexia nervosa, loss of taste and smell, loss of appetite, low libido, PMS
  • Iodine: thyroid dysfunction”

For floxies, I wonder if the fluoroquinolone begins the cycle of mineral replacement. Fluoroquinolones chelate minerals, then mercury binds to the site that was vacated by the mineral, then mercury toxicity leads to chronic health conditions.

There are many “drug muggers” out there – drugs that deplete vital minerals and nutrients from the body. I wonder if all the drugs that deplete necessary minerals from the body are opening people up to mercury poisoning.

There are a variety of factors that determine how well one’s body can deal with mercury. Genetic factors such as MTHFR mutations (which play a role in determining how well a person deals with toxins) certainly play a role, as do an individual’s antioxidant levels. Many floxies have MTHFR mutations, and fluoroquinolones have also been shown to deplete glutathione and other antioxidants. Some floxies, including Richard and the author of Say Friend and Enter, have dealt with mercury poisoning issues as well as fluoroquinolone toxicity issues. Obviously, people who suffer from fluoroquinolone toxicity are less adept at metabolizing and clearing fluoroquinolones than those who take Cipro, Levaquin and Avelox without ill effects. Perhaps floxies are less able to handle other toxins, including heavy metals, as well.

There are a variety of mercury detoxification protocols that you can find online. Dr. Mercola’s protocol seems like a good place to start – http://www.mercola.com/article/mercury/detox_protocol.htm. He suggests:

  1. Avoid sugar, milk, grains and processed foods
  2. Eat foods that increase glutathione
  3. Take probiotics and eat probiotic rich foods
  4. Supplement magnesium
  5. Supplement chlorella
  6. Supplement MSM
  7. Eat garlic and cilantro
  8. Supplement minerals
  9. Make sure that you have sufficient hydrochloric acid levels to absorb minerals from your food
  10. Supplement vitamins C and E
  11. DMPS therapy

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Please note that chelation therapies (DMPS) can be dangerous and they should not be done without the direct supervision of a doctor. They can be hard on the kidneys, so they should also not be done unless absolutely necessary. Be careful, please!

As I noted earlier, this post is about possible connections, not established facts. Fluoroquinolones are not documented to have anything to do with mercury toxicity according to the journals I could find. The symptoms of fluoroquinolone toxicity and mercury poisoning are similar though, and given that fluoroquinolones have been documented to have profound effects on cellular mineral homeostasis, I think that it’s a hypothesis that’s worth exploring.

Post-script – If anyone reading this gets their mercury levels tested, please let me know what the tests say – I’m quite curious. Thank you!

Post-post-script – I wanted to point out some comments that Jason recently made on the floxie hope home-page about mercury. He has done extensive research on the topic and what he has to say is certainly valuable:

Toxic Metals and other Toxic substances (like Cipro…) are a HUGE issue, and as I guess you have gathered a mouth full of Mercury is bad situation to be in, and a major potential cause of Brain Fog and many many more issues for someone. This can be grossly exaggerated with someone with a MTHFR Gene issue, since they will NOT be able to detox Metals, Fluorides, Chlorine’s, and all the other Toxic Waste/Toxic Metals/Chemicals that we are subjected to on a daily basis properly, thus they will build up in the body and make the person more and more unwell. Since you are in the USA, for $99 the 23andme test is definitely a “no-brainer” in my opinion if you have not done it already, to find out if you do have these issues or not, on top of potentially being toxic in Mercury and other Metals.

Pretty much every living person has a toxic burden, Metals, Halides, and more; many people are able to keep it low enough to be healthy because their Methylation pathway works properly, actively detox, etc but others are not so lucky, and are even more unlucky if they do not realize this is the cause of most/all their issues. There was a whole bunch of discussion on Genes and the 23andme test last page starting from post 2 if you are interested in finding out more about this important part of someone’s health.

I would suggest to find a good ND, but be very careful with “Challenge Tests”. Many of them will want to give you a dose of DMSA or something else like DMPS, EDTA, etc and often the doses are VERY big, and quite dangerous (a big dose will ensure high levels show up on test, ensuring more money for them since you will “need” treatment = dangerous greed tactic). DMSA will mobilize several toxins in the body all at once, and if a person’s toxic load is large enough the body will not be able to handle all the poison being in the system at one time, and terrible damage can result. If you google Andy Cutler you will see he recommends not doing a challenge test at all, many people are following his advice and his Protocol for detoxing the body of Metals, he believes it needs to be done is slow safe fashion, which makes sense to me.

I myself am a little torn on the “testing issue”. I had a hair test done for Metals and Minerals which is what many people recommend you do to find out your toxic load. The things is it does NOT give you the whole picture, it is really telling you what the body is “expelling”, it is NOT telling you what your body is potentially harboring, since many of the Metals are hidden/stored in the body in Fat Cells, like the Brain, and if not mobilized they just sit there and screw you over, and will not come out in the hair, thus your hair test could say you are “low” in Uranium, or Nickel, but in fact you are not low, you are just not efficiently expelling/detoxing it at the time of the test. However, if the test shows you are high in something, there is a good chance you are actually too high and your body is trying to detox the excess of which some of it ends up in the hair. So these levels that show up, are somewhat dependent on if someone has a Methylation issue also, since poor Methylators are poor detoxer’s potentially skewing the results.

Having said all that, it is one of the best tests to do for this, and highly recommended to do regardless to find out what your Mineral profile looks like, though I still think there might be some viability of a “safe challenge test”, which would be as described above only with a smaller safer amount of a Chelator given right before a Urine test. Yet the reliability of the Hair test for Minerals is too somewhat questionable, out of the 100 or so labs around the USA that do these tests, 98 of them WASH the hair before doing the test. The trouble with this is many of the Minerals are water soluble, so washing the hair with a mild detergent and acetate like most do can skew the results of many of the Minerals. Google “Dr. Wilson Hair Test” and you will see more of what I am talking about. You will also find recommended ND’s on his site that use the one good lab in the USA that do not wash the hair.

This is all my opinion, one that is shared but none-the-less where I stand on the whole thing. I apologize for not giving a “Clear” solution, but this is frankly because in my opinion there isn’t one. As a result, for many years I did “nothing”, I now regret this and don’t recommend that course of action either. For yourself, my unprofessional recommendation is to “not” have a challenge test done, especially with Mercury still in your mouth, also do NOT take any chelators, and avoid Cilantro too, as this crosses the Blood Brain Barrier and taking this can bring Metal from the Mouth/Body right into the Brain. Doing the Hair test is a good idea, it will give you at least some idea on what is going on in your body, and if we are to believe Dr. Wilson, a VERY good idea, he has written a very long book on Hair Tests (his Mentor invented the idea) and how to interpret them, one I wish I had, but there is a lot of info on his website and ARL Labs website (the one he recommends) about how to interpret the results, and a good ND will hopefully be educated on these methodologies. Regardless of the results, if you can afford it if I was you I would find a good Huggins Dentist (trained in removing Mercury fillings safely) asap and start getting those removed. I had one that was “cracked”, and have no doubt it has caused me issues. Good luck, if you do have a heavy toxic load please be patient in its removal.

AND

I think the most popular is the Andy Cutler Protocol, which is a very slow/safe but PITA method, and uses synthetic Amino Acid Chelators DMSA, DMPS and also ALA all in small doses on a very strict time schedule due to their half lives. Lots of info on net about this you will see, chelators are bought from company out of Africa IIRC, there is a good Yahoo support group/forum where people answer questions etc (poorly organized unfortunately)

There are some others of note, and some are opposed to Cutler method such as Dr. Lawrence Wilson http://drlwilson.com/articles/chelation.htm (very good website with a TON of info on everything health). EDTA can be used, Dr. Mercola has made some suggestions like using Cilantro and others, funny enough Cutler warns against using EDTA and Cilantro, for potentially valid reasons, confusing the issue further. 😦

I think the best course of action for someone depends on many things. Do they still have Mercury fillings? Do they have the MTHFR & other mutations in their Genes? (found out with 23andme test) How big is their toxic load?

The first course of action is always to get fillings removed safely, and then getting a Hair metal/mineral test done. To me getting the 23andme test for $99 should be done too, for reasons I noted on FH. Then with that done, and with that information a suitable course of action can be recommended (I sound like a bluddy Naturopath here….) If someone has a huge toxin burden, I think the Cutler method makes sense, but the MTHFR could complicate this. If someone is moderately toxic, Cutler method might still be good, or a combination of ideas might be good enough, again depending on the MTHFR issue. If someone is only mildly toxic, they should for sure address the MTHFR issues first and foremost, which would help the body alleviate the burden on it’s own (of course with a MTHFR issue someone is likely NOT going to have small burden, depending on their age and exposures of course). Also with smaller toxic burden, things like Cilantro, Wheat Grass and regular exercise and Saunas should be enough to bring the burden down, assuming they limit their future exposures.

I hope that helps, unfortunately the waters are a little muddy on this, not unlike Cipro poisoning.

Just a final note that these are only my “untrained” opinions. Toxic load is a serious wide-spread issue, causes very serious health issues, and removal has to be taken very seriously and not “toyed” with, someone needs to put their trust in a professional or do a whole lot of research. There are many complicating factors, such as Candida overgrowth (something DMSA potentially stimulates), MTHFR & other Genes, current past/health problems of the person and things like condition of Liver/Kidney’s, Cancer, FQ toxicity, etc. (Emphasis added by Lisa.)

I also forgot to mention Spirulina & Chlorella, although I did mention Dr. Mercola, and this is 2 things he advocates. They are also something Dr. Sircus recommends (along with a few others, see link), here is a good article on the whole topic here: http://drsircus.com/medicine/essentials-natural-chelation

He actually gives a LOT of accurate advice in this article in my opinion, like his notes on ALA which are important, and note what he says about Magnesium too, which applies 10 fold to a Floxie with Heavy Metals. He notes that some studies found Chlorella on its own, did not seem to chelate anything effectively. However when used with Cilantro, it does, and this makes perfect sense to me because Cilantro is a “mobilizer”, it irritates the Metals stored and Chlorella is a “binder”, it is extremely absorbent and will bind to Metals to help them exit the body and not be “re-absorbed” once they are mobile, which is critical. Done wrong, the Metals from one area can mobilize and then be re-absorbed in other areas causing great oxidative damage like to the Brain.

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But Antibiotics Save Lives!!!

David Wolfe, a health, eco, nutrition and natural beauty expert (more information about him can be found HERE) posted the picture above on facebook.  He has more than 1,200,000 facebook followers and I greatly appreciate his help in spreading the word about the dangers of fluoroquinolones!  Many people commented on picture and told their story of how fluoroquinolones hurt them.  There are a lot of us out there, and the more the word gets spread, the more likely change is.

As always, there were some nay-sayers.  Honestly, there were a lot more people sharing their stories than there were nay-sayers, and I’m not suggesting that we all gang up on them, but I have some thoughts about the some of the nay-saying comments.  Here are some examples of the nay-saying comments:

“Want to go back to the dark ages before antibiotics?”

“If we didn’t have antibiotics…alot of people would die..”

“People who don’t believe in medicine should live on their own island of ignorance and watch their life expectancy drop to that of their intelligence.”

“Without antibiotics you can’t treat people with bacterial infections. Aka ur screwed. Pls don’t mislead the public. stick to quotes. My sincere request. Please.”

“Antibiotics have saved over 1 billion lives. Mr Wolfe’s irresponsible comments will cause deaths!!”

“WAIT! Are you trying to scare people off antibiotics now??? How many people would have to die of preventable illnesses before you retract this?”

Sigh.  Why do these people think that all antibiotics are the same?  Why do they think that all antibiotics are safe?  Why do they think that warning people about the dangers of fluoroquinolones equates to being anti-antibiotic?  Where is the grey area?  Can’t some antibiotics be appropriate for use in some circumstances but not others?  Can’t different antibiotics have different safety profiles?  Isn’t information about the dangers of drugs valuable so that people can make informed choices?  Doesn’t it matter that fluoroquinolones damage nerves, the musculoskeletal system, the eyes and kidneys?  Can’t that information lead to greater consumer knowledge and informed consent when fluoroquinolones are prescribed?  Can’t the dangers of fluoroquinolones be acknowledged without being “anti-antibiotic?”  Can’t we fight for prudent and appropriate use of all antibiotics (especially FQs) without negating the lives that have been saved by antibiotics (including FQs)?  GREY AREA, folks!  The world isn’t black and white.  Sigh.

A quote from my most recent post, “‘The 21st Century Cures Act’ Is On Its Way – Here’s Why You Haven’t Heard About It” seemed like an appropriate response to a lot of the nay-sayers.  Feel free to use this if you want it:

“A healthy and balanced microbiome (“the ecological community of commensal, symbiotic and pathogenic microorganisms that literally share our body space”) is crucial for all areas of health, and a disturbed microbiome has been linked to all of the diseases of modernity, including mental health disorders, neurodegenerative diseases like Parkinson’s and Alzheimer’s, autoimmune diseases, inflammatory bowel disease and Crohn’s disease, mysterious diseases like fibromyalgia, autism, etc. And while there is acknowledgement of the role that a healthy microbiome plays in these diseases, researchers and journalists alike have been loath to acknowledge the role antibiotics have played in contributing to these diseases of modernity. No one wants to be anti-antibiotic. Everyone knows that antibiotics have saved millions of lives, but that doesn’t mean they are without consequences. And the good that penicillin has done doesn’t mean that all antibiotics are equally safe or effective. I can make a pretty thorough argument that fluoroquinolone antibiotics, like Cipro/ciprofloxacin and Levaquin/levofloxacin, drugs that work by “inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV (both Type II topoisomerases), which are required for bacterial DNA replication, transcription, repair, and recombination,” are at least partially responsible for many of the diseases of modernity (more information can be found HERE, HERE and HERE). Fluoroquinolone antibiotics do not have the same safety profile as amoxicillin, and to assume that they do because both are categorized as antibiotics, is foolish on multiple levels.”

That’s my two cents of a response to the people who say things like the quotes above.  Also, quit giving carte blanche to the pharmaceutical companies if they label their dangerous drug as an antibiotic, because that’s just stupid.

Now I’m done.  🙂

 

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What is Fluoroquinolone Toxicity? (Part 2)

 

The first post I wrote on Floxie Hope was a post entitled, What is Fluoroquinolone Toxicity???  It went over some theories that I had heard about FQ toxicity, and, more importantly, what FQ toxicity felt like.  It was a good start.

Since I wrote that post, I have done hundreds of hours of research on fluoroquinolones.  The research has resulted in this, updated post –

WHAT IS FLUOROQUINOLONE TOXICITY? on Hormones Matter.

It goes over some theories about the damage that fluoroquinolones do to the body.  It’s clear that fluoroquinolones do a lot of damage.  I wish that there were more researchers putting all the pieces together.

Luckily, understanding exactly what fluoroquinolone toxicity IS, isn’t required for healing.

 

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The Floxie Hope Podcast Episode 12 – Elise

Elise Floxie Hope Podcast

 

I had the pleasure of interviewing Elise for Episode 12 of The Floxie Hope Podcast.

Elise shares a lot of valuable information in her podcast.  She goes over her long journey of fluoroquinolone toxicity, and things that she has done to heal, in the podcast.

You can listen to the podcast through these links –

http://www.floxiehopepodcast.com/episode-012-elise/

https://itunes.apple.com/us/podcast/floxie-hope-podcast/id945226010

Elise has generously offered to help anyone who wants to reach out to her –

Elise’s facebook info: https://www.facebook.com/elise.child.5

Email: elisedchild@gmail.com

In the podcast, Elise mentions that her naturopathic doctor, Dr. Cynthia Buxton, has helped her immensely.  Dr. Buxton can be found through this link – http://naturalhealthcarenw.com/?p=346

Elise was also helped by eating for her blood type.  Information about that can be found here – http://www.4yourtype.com/

The TQI diet also helped Elise – http://toquietinflammation.com/

Univera Xtra also helped Elise – https://www.newunivera.com/en-us/search?Text=xtra&Area=Products

Elise also found Cleansing/gut health options to be helpful: https://humaworm.com/, http://www.renewlife.com/herbal-cleansing/paragone.html

Liver support: Elise currently takes a tincture with milk thistle, dandelion, etc.

Elise noted, “I forgot to mention the value of amino acid therapy in my own healing, which can be extremely helpful with depression, anxiety, insomnia, getting off of antidepressants, etc. I feel it is very important to do this with one’s doctor for dosage, length of use and quality of supplements. Amino Acid Therapy Info: (some examples, lots of info out there) http://www.neurogistics.com/thescience/aminoacids.asp, http://www.antianxietyfoodsolution.com/wp/wp-content/uploads/2014/11/Anxiety-mood-emotional-eating-sugar-cravings-mood-quiz-by-Trudy-ScottV2.pdf

If you have any questions about any of these products, please contact Elise.

Thank you for listening to The Floxie Hope Podcast!  Stay hopeful, friends!

 

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FDA Testimony

Generic Fluoroquinolone Testimony FDA

Me practicing my speech. I won’t wear my fleece hoodie for the real thing. :p

I’m in Washington D.C. and will be testifying to the FDA at approximately 8:30 am EST on Friday March 27, 2015.  Rachel Brummert, President of the QVF will be testifying at approximately 3:50 pm EST the same day.

You can view our testimony through the webcast link noted in this FDA meeting announcement – http://www.fda.gov/Drugs/NewsEvents/ucm431265.htm

Rachel and I will do our best to tell stories of pain and suffering caused by fluoroquinolones, and to encourage the FDA to change the rules that are keeping people who are hurt by generic drugs from gaining recourse through the justice system.

A couple of notes – I wasn’t able to fit in all of the stories that were sent to me.  I had to cut many poignant stories because of time–I’m allowed to speak for 5 minutes.  Everyone who sent me your story – THANK YOU!  I wish that I could tell them all!

Also, this hearing is not about fluoroquinolones specifically.  It is about the fact that generic drug manufacturers cannot be held legally responsible for the damage done by their products.  Many people who have been hurt by various generic drugs will be testifying.  Generic drug manufacturers will also be testifying.  I can’t imagine what they’ll say though.  Are they actually going to argue that they shouldn’t be held responsible for the safety of their products?  Probably.  But if they can’t be held responsible for the damage done by their products, who will be held responsible?  The FDA?  Last I checked, suing government agencies wasn’t possible.  Generic drug manufacturers need to be held responsible for the damage caused by their drugs.  I hope that the FDA does what is in their power to make generic pharmaceutical companies liable for the drugs they make.

 

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The Floxie Hope Podcast Episode 11 – Diego

Diego Floxie Hope Podcast

I had the pleasure of interviewing Diego Vasquez for Episode 11 of The Floxie Hope Podcast.

Diego is thoughtful and wise.  His perspective on his floxing journey is poignant and beautiful.  I very much enjoyed speaking to Diego and he even brought me to tears during the interview.  I encourage all of you to listen to this podcast and share it with friends.  Diego has an amazing, uplifting, inspirational spirit.  You will be sure to be touched by this interview.

You can read about Diego’s Journey here – https://floxiehope.com/diegos-story-levaquin-side-effects/

You can listen to Diego’s Journey through these links –

https://itunes.apple.com/us/podcast/floxie-hope-podcast/id945226010

http://www.floxiehopepodcast.com/episode-011-diego/

Diego mentions that he is being treated for peripheral neuropathy by The San Antonio Neuropathy Center.  You can learn about the Center from this video –

 

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Testifying for Justice for Victims of Generic Drugs

Thousands of victims of generic ciprofloxacin, levofloxacin, moxifloxacin and ofloxacin have been unable to pursue legal recourse because of a couple of Supreme Court decisions that ruled that generic drug manufacturers cannot be held liable for harm caused by their products.

You can read more about these horrible Supreme Court decisions in this June, 2013 New York Times article, “In 5-4 Ruling, Justices Say Generic Makers Are Not Liable for Design of Drugs.

People are just as legitimately hurt by generic drugs as they are by name-brand drugs.  Arbitrarily taking justice away from a person because they were hurt by a generic drug is infuriating and wrong.

I have been given the opportunity to do something about this horribly unjust situation.

I have been invited by the American Association for Justice to speak at a Congressional Hearing on Capitol Hill on March 26th and to testify at a FDA hearing on March 27th regarding the lack of legal recourse for those hurt by generic pharmaceuticals.

This is a VERY exciting opportunity and I am honored to be able to tell Congress and the FDA about the harm that generic fluoroquinolones have done, and to encourage them to enact legislative changes that enable those who have been harmed by generic drugs to seek recourse and gain justice.

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Rachel Brummert, President of the Quinolone Vigilance Foundation, will also be presenting/testifying and you can learn more about what this opportunity will involve for both of us by reading the March 6th post on www.saferpills.org, “Executive Director Rachel Brummert speaking at Congressional Hearing and FDA Hearing.

It would be great if as many stories as possible about the pain caused by generic fluoroquinolones could be heard.  There are a couple of ways that you can share your story of pain caused by a generic fluoroquinolone, and the lack of justice available to you.

First, you can submit a comment to the FDA.  Instructions on how to do so can be found in the March 4th post on www.saferpills.org, “Generic Drug Victims: Share your story.”  I encourage EVERYONE to submit their story as a public comment.  Public comments really do make a difference!

Second, both Rachel and I would love to share some of your stories in our testimonies.  If you can please email either of us your stories, and what you would like us to say on your behalf to Congress and the FDA, we will appreciate it!  My email address is floxiehope@gmail.com and Rachel’s is Rachel@saferpills.org.  Rachel and I will coordinate so that we can tell as many stories as possible within the time allotted to us.  We can’t promise that we’ll be able to get to everyone’s story, and we will need to edit the stories for time and relevance, but we would love to share as many impactful stories as possible.  Please send either me or Rachel your stories / what you want us to say on your behalf, asap.  We need to get a drafts of what we are going to say to the American Association for Justice by the end of this week.  Sorry for the time crunch and thank you very much!

Thank you,

Lisa

 

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Why Hasn’t Levaquin Been Taken Off The Market?

In 1992 the fluoroquinolone antibiotic Omniflox/temifloxacin was removed from the US market after causing three deaths.

To note the removal from the market, the FDA released the following statement:

            “The Food and Drug Administration today announced that Abbott Laboratories of Abbott Park, Ill., is voluntarily recalling the broad-spectrum anti-infective drug Omniflox (temafloxacin) tablets, and will halt all further distribution of the drug.

            This action is being taken because of severe adverse events associated with the use of the drug that have been reported to the company and to FDA in the first three months of marketing.

            Temafloxacin was approved in late January 1992 and marketed in mid-February.  Since that time there have been approximately 50 reports of serious adverse reactions, including three deaths.  There were several cases of severe low blood sugar, especially in very elderly patients with decreased kidney function.  Among the severe reactions there were a number of cases of an unusual complex of adverse reactions consisting of hemolitic anemia (destruction of red blood cells) and other blood cell abnormalities.”

I’m glad that Omniflox/temafloxacin was removed from the market.  I’m glad that, in 1992, the FDA was able to move quickly to do the right thing and take a dangerous drug off the market.

It begs the question though – Why is Levaquin/levofloxacin still on the market? 

Levaquin/levofloxacin has caused far more than three deaths.  According to an FDA review with the subject, “Pediatric Exclusivity Postmarketing Adverse Event Review,” between 12/20/1996 and 08/27/2008, 924 people were killed by Levaquin/levofloxacin, including three children.

levofloxacin AERS Data

It should be noted that, “Many studies have documented that only 10%-15% of serious adverse reactions are reported” to the FDA.  Seeing as adverse reactions to Levaquin/levofloxacin, and other fluoroquinolone antibiotics, are often delayed and bizarre in their nature (who would think that multi-symptom, chronic illness could result from taking an antibiotic?), it is reasonable to think that only 10% of the reactions to  Levaquin/levofloxacin are reported to the FDA.

Assuming that only 10% of the harm was reported, 9,240 people (including 30 children) were killed by Levaquin/levofloxacin in the 12 years measured.

Additionally, there were 10,166 reports of harm done by Levaquin/levofloxacin in that time period.  If that’s 10% of the actual harm done, 101,660 people were harmed by Levaquin/levofloxacin in that 12 year period.

Again, THREE people died from Omniflox/temafloxacin before it was promptly pulled from the market in 1992.  Johnson & Johnson is apparently on friendlier terms with the FDA than Abbott Labs.

Rest in Peace Chris Dannelly

Since 2008, Levaquin/levofloxacin has claimed many more victims.  Chris Dannelly is one of the people who tragically died after taking levofloxacin in January, 2013.  Chris was a 41 year old husband and father of two young kids.  He was an athlete at the prime of his life.

Chris FQWall

Chris was killed by two pills of levofloxacin.  You can read Chris’s story HERE.  From Chris’s Story, “After reviewing the autopsy report, doctors stated that ‘all signs point to Levaquin’ as being the cause of death.” And, “Chris was a healthy, active man in the prime of his life. He worked out five days per week, and enjoyed playing both indoor and outdoor soccer regularly. Within a matter of less than a week’s time he went from being perfectly healthy, to losing his life…all because he took two little pills of Levaquin.”

Chris’s tragic story, highlighted by WSB-TV 2 out of Atlanta, Georgia, and told by Chris’s brave wife Kathy, can be viewed here –

Kathy states in the interview, “If I can get involved in this drug somehow coming off the market one day – then that’s the least I can do.”

Because Chris was given levofloxacin, the generic form of the drug, and the Supreme Court decided that drug manufacturers couldn’t be held responsible for harm caused by generic drugs, neither Kathy nor her children have the opportunity to pursue legal recourse for Chris’s tragic death.  Taking this horrible drug that killed her husband off the market is the least the FDA can do to right this tragic situation of a husband, father and athlete being killed by a dangerous drug like Levaquin/levofloxacin.

Rest in Peace Richard Davis

Also on  WSB-TV 2 Atlanta, Sandy Davis tells the story of how her husband Richard was killed by Levquin/levofloxacin:

Sandy Davis states, “I don’t think it should even be on the market.  If it’s killing people – No.”  Indeed.  Richard was 60 years old when he passed.

But, but, but…

People will argue that we need Levaquin/levofloxacin because bacterial resistance to antibiotics is making more powerful antibiotics necessary.  There may be some truth to that argument.  But rather than seeing dangerous, complex drugs like Levaquin/levofloxacin in simplistic black and white terms, perhaps some thoughtful consideration of the grey area is in order.

IF it is deemed impossible for the FDA to remove Levaquin/levofloxacin from the market (and I do believe that it should be taken off the market – it is, after all, KILLING PEOPLE), it should be severely restricted.  Levaquin/levofloxacin should ONLY be used in life or death situations.  It should ONLY be used when all other non-fluoroquinolone antibiotic options have been exhausted.  It should ONLY be used in patients who haven’t previously been exposed to fluoroquinolones.  It should ONLY be used in people who are not genetically predisposed toward an adverse reaction to fluoroquinolones.  (Who is genetically predisposed toward an adverse reaction to Levaquin/levofloxacin?  Good question.  Figure it out, FDA.)  It should NEVER be given to children, athletes, the elderly, those with an autoimmune disease, those with autonomic nervous system dysfunction, those with a history of psychiatric illness, or anyone who needs to use contraindicated drugs, like steroids and NSAIDs, to survive.

IF Levaquin/levofloxacin must stay on the market, everyone who takes it should be provided with information that ensures that they know that Levaquin/levofloxacin can cripple or kill them.

Before anyone insists that Levaquin/levofloxacin must stay on the market, perhaps we (collectively) should do some due diligence to make sure that it, and other fluoroquinolone antibiotics, don’t have intergenerational adverse effects.  After all, their mechanism of action is interruption of topoisomerase enzymes, enzymes that are necessary for DNA and RNA replication.  In case it needs to be said, disrupting the DNA and RNA replication process of cells may have some deleterious effects on future generations.  Don’t assume for a second that this concern has been examined.  Warnings about the DNA toxicity of fluoroquinolone antibiotics have been ignored.

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Though I understand that antibiotic resistance and loss of antibiotic efficacy is a problem, I can’t say that I entirely buy arguments that Levaquin/levofloxacin must stay on the market.  No one claims that we are worse off because Omniflox/temafloxacin was removed from the market.  Infections were also being adequately treated by non-fluoroquinolone antibiotics prior to 1987, when Levaquin/levofloxacin was approved by the FDA.

Kathy Dannelly and her children, Sandy Davis and her loved ones, and all other loved ones of victims of Levaquin/levofloxacin deserve justice.  Many of them aren’t getting justice.  The least that the FDA can do is keep others from dying in pain from fluoroquinolone toxicity caused by Levaquin/levofloxacin.

 

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Media Coverage of Fluoroquinolone Antibiotic Dangers

WSB-TV 2 out of Atlanta, Georgia has run several news segments about the dangers of fluoroquinolone antibiotics – focusing on the death and destruction caused by Levaquin/levofloxacin.

A HUGE THANK YOU TO EVERYONE INVOLVED IN MAKING THIS POSSIBLE!  WSB-TV 2 producers and other staff, Jim Strickland, Kathy Dannelly, Donna Schultz, Jeff Stephens, Lynne Whitcopf, Dr. Keith Jeffords, Sandy Davis and everyone else who spoke up about the dangers of these drugs – THANK YOU!

Here are the video clips from WSB-TV 2 –

You can read the story here – http://www.wsbtv.com/news/news/local/local-woman-says-popular-antibiotic-killed-her-hus/njzwj/

Per The Quinolone Vigilance Foundation‘s facebook page, “QVF has just been informed moments ago by ABC2 WSB-TV that the number of shares from the news stories have increased from 2 million to 3.9 million.”  WOW!  Great job getting the word out!

Here is another story featuring Lynne Whitcopf and Dr. Keith Jeffords, and their stories of pain –

http://www.wsbtv.com/news/news/local/patients-suffer-devastating-side-effects-popular-a/nj4Br/

When a doctor reports that, “It was an amazing amount of pain, to the point that I couldn’t walk,” and has to crawl out of the hospital to avoid more fluoroquinolones, you KNOW that the situation is bad.

Sandy Davis sadly lost her husband Richard to levofloxacin.  Here is her story –

http://www.wsbtv.com/news/news/local/woman-says-popular-antibiotic-levofloxacin-killed-/nj5jY/

I’m so sorry for the pain that was experienced by all those who were interviewed.  I appreciate that each of you told your story of pain!  These stories are important!

 

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The Floxie Hope Podcast Episode 7 – Brett Peto

Brett Peto The Floxie Hope Podcast

On episode 7 of The Floxie Hope Podcast I had the opportunity to interview Brett Peto.  Brett was only 21 years old when he got floxed by levofloxacin.  After taking levofloxacin, Brett went from being in the peak of his physical fitness (as 21 year olds should be) to having aches, pains, muscle freezing, weakness and more musculoskeletal problems.

Brett and I discussed the things that have helped him through fluoroquinolone toxicity.  In addition to magnesium and the information that he got from Floxie Hope, he was also helped by the support and love of his friends and family.  We discuss the healing that art and laughter and community can bring.  We also discuss how Bret’s perspective was changed by his experience with fluoroquinolone toxicity.  The medical system lost credibility with Brett after he was poisoned by levofloxacin.  He has found a good doctor to work with though, and is trying not to be too jaded from his experience.

Brett mentions his book, The Updraft, in the podcast, and how writing was healing for him.  You can purchase The Updraft HERE.

You can listen to Episode 7 of The Floxie Hope Podcast featuring Brett Peto through the following links –

http://www.floxiehopepodcast.com/episode-007-brett-peto/

https://itunes.apple.com/us/podcast/floxie-hope-podcast/id945226010

Thank you very much for listening to The Floxie Hope Podcast!

Reviews of The Floxie Hope Podcast on iTunes are GREATLY appreciated!

If you have any topic suggestions, or if you would like to be on The Floxie Hope Podcast, please let me know.  You can reach me through the Contact link on this site.

 

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The Floxie Hope Podcast Episode 5 – Rose Casanova

Floxie.Hope.Podcast.1800.72.dpi

Rose joined me for Episode 005 of The Floxie Hope Podcast.  In this episode, Rose shares her journey through fluoroquiolone toxicity and discusses how getting floxed changed her perspective on medicine.

You can listen to Episode 005 of The Floxie Hope Podcast through iTunes –

https://itunes.apple.com/us/podcast/floxie-hope-podcast/id945226010

It will be greatly appreciated if you log into iTunes and leave a review of The Floxie Hope Podcast.  Subscriptions through iTunes (or any other podcatcher) are greatly appreciated too.  Thanks!!

You can also listen to the podcast directly through this link –

http://www.floxiehopepodcast.com/episode-005-rose-casanova/

Thank you very much for listening to The Floxie Hope Podcast!  Getting our voices out there, and telling our stories, is helpful.

Thank you, Rose, for sharing your story!!!!

 

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Antibiotic Resistance – Can We Please Stop Being Stupid?

Can I just complain about how ridiculously STUPID the over-use of antibiotics in agriculture is?  Antibiotics are regularly used prophylactically in livestock in order to fatten up the animals and to compensate for the abhorrently unsanitary conditions in commercial feedlots.   Neither of those things are okay in the least.  They are appalling in themselves.

But if you don’t care that pigs, cows, chickens and turkeys are dirty and fat, you may say, “so what?”

The “so what” is that pathogenic bacteria are QUICKLY adapting to antibiotics and are getting stronger.  This is speeding up the process of antibiotic resistance among bacteria that can not only make livestock sick, but can also make humans sick.  When YOU get sick with one of these bacterial infections that is resistant to antibiotics, well, you may be screwed, because even fluoroquinolones don’t touch some of these nasty, antibiotic resistant, bacteria.

According to the CDC:

“Each year in the United States, at least 2 million people become infected with bacteria that are resistant to antibiotics and at least 23,000 people die each year as a direct result of these infections. Many more people die from other conditions that were complicated by an antibiotic-resistant infection.”

For a while the CDC, FDA and others, led by the pharma and big-ag lobbies, tried to BS (lie to) us all by saying that antibiotic resistance in livestock had nothing to do with antibiotic resistance to humans.  The 2013 CDC Report on Antibiotic / Antibmicrobial Resistance settled that argument as it noted that:

“Antibiotics are widely used in food-producing animals, and according to data published by FDA, there are more kilograms of antibiotics sold in the United States for food-producing animals than for people… This use contributes to the emergence of antibiotic-resistant bacteria in food-producing animals. Resistant bacteria in food-producing animals are of particular concern because these animals serve as carriers. Resistant bacteria can contaminate the foods that come from those animals, and people who consume these foods can develop antibiotic-resistant infections. Antibiotics must be used judiciously in humans and animals because both uses contribute to not only the emergence, but also the persistence and spread of antibiotic-resistant bacteria.”

Here is a good article in Wired explaining the CDC report – “CDC Threat Report: Yes, Agricultural Antibiotics Play a Role in Drug Resistance.”

The reports are in.  The scientific consensus has been stated.  Over-use of antibiotics in agriculture is hurting humans.  So, perhaps we should stop over-using antibiotics in agriculture.  That seems like a good idea.  Too bad the big-ag and pharma pockets are deep and they control the hearts and minds of legislators.  More info on that can be found here – http://www.healthline.com/health/antibiotics/politics-pork-and-poultry-why-legislation-has-not-passed

As bacteria in livestock become resistant to penicillin and sulfa antibiotics, fluoroquinolones will be used more frequently.  Fluoroquinolones already are being used in livestock, just not as frequently as other, safer, antibiotics.  But as bacteria become resistant to safer antibiotics, fluoroquinolone use will surely increase.  For humans as well, as antibiotic resistance increases, fluoroquinolone use will increase.  Doctors will have to pull out the “big guns” because the smaller ones will no longer work.

Antibiotic resistant bacteria are not only harming livestock and people, they are harming the earth itself.  The animals that are given antibiotics excrete those antibiotics (everybody poops – and pees) and the antibiotics go onto the earth / the soil.  This messes up the microbiome of the soil (yes, soil has a microbiome) and more antibiotic resistant bacteria thrive in the soil.  That’s the topic of THIS POST.  Our earth is, literally, getting floxed.  It’s going to get worse too, as stronger and stronger antibiotics become preferred in agriculture, because the traditional ones are no longer doing the job.  The fluoroquinolones will hurt the animals that they are given to, destroy the microbiome of the soil, and leave us Floxies with nothing to eat.  Great.

I wish I didn’t think this was going to happen in my lifetime, but I fear that it will.

The antibiotic arms race will likely continue, with increasingly powerful antibiotics being developed to compensate for antibiotic resistance.  Those synthetic antibiotics will likely have the same, or worse, devastating “side-effects” as fluoroquinolones.  Destruction of the microbiome and destruction of mitochondria is consequential for human health, animal health, and the health of the earth itself – the soil.  Though the importance of the microbiome is starting to be recognized, it may be too late to stop destroying our microbiome with antibiotics.  (The alternative is to fight pathogenic bacteria with helpful bacteria.)  We are accustomed to turning to drugs, and to wantonly killing bacteria.  I don’t see us stopping any time soon.

The bacteria will die – because there isn’t any political will to stop being foolish with antibiotics.  The insects (pests) will die – because there isn’t any political will to protect them from pesticides.  The bees will die – because corporate profits are, apparently, more important than our food supply.  The frogs will die – because no one understands non-linear hormonal responses.

Perhaps, with a painful number of human deaths from this ridiculousness, we’ll, collectively, stop being so stupid.  Maybe.  Because 23,000 human deaths per year (from antibiotic resistant bacteria) haven’t made policy-makers do squat about the over-use of antibiotics in agriculture.  Recommendations for prudent antibiotic use are put into place, but no actual changes are made.  Recommendations.  Recommendations will do nothing to solve this problem – nothing.

P.S. – Sorry for not being hopeful.  Here’s something I hope – I hope that the canaries in the coal mine are listened to.  That’s what we are – canaries.  Is anyone listening?

 

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Fluoroquinolone Induced Gene Upregulation and ROS

The article, “The Fluoroquinolone Levofloxacin Triggers the Transcriptional Activation of Iron Transport Genes That Contribute to Cell Death in Streptococcus pneumonia” is difficult.  It’s not light reading.  I wish it was.  I wish the articles that have information about how fluoroquinolones affect cells were easy to understand and to read.  I wish that we had easy, simple answers about how fluoroquinolones lead to the myriad of adverse events that are listed on the FDA warning labels for them.  I wish that more was known about how fluoroquinolones work.  I wish that a list of definitions wasn’t necessary at the beginning of this blog post.  But this stuff is hard, and a list of definitions is necessary, so, hereyago (some definitions paraphrased from the Wikipedia article because it’s easiest and I’m not a biochemist – for more info, go to the wiki page, or elsewhere):

Reactive Oxygen Species (ROS):  “Reactive oxygen species (ROS) are chemically reactive molecules containing oxygen. Examples include oxygen ions and peroxides. ROS are formed as a natural byproduct of the normal metabolism of oxygen and have important roles in cell signaling and homeostasis.  However, during times of environmental stress (e.g., UV or heat exposure), ROS levels can increase dramatically. This may result in significant damage to cell structures. Cumulatively, this is known as oxidative stress. ROS are also generated by exogenous sources such as ionizing radiation.”  ROS can be incredibly nasty.  They can lead to cellular damage, including DNA damage, and are related to every chronic disease there is.  They’re also related to ageing.  As damage from ROS (also called oxidative stress and free radicals) accumulates, ageing and the diseases of old age occur.  Interestingly though, ROS are not all bad.  They serve as signaling mechanisms within cells and play a large role in turning genes on and off (epigenetics).  They need to be in balance.  If they’re not in balance, a whole lot of things can go wrong.  They’re kind of like tequila.  A shot of tequila mixed with lime juice and other goodies, is excellent in a margarita.  But if you drink the whole bottle, and then mix it with some whiskey, it’s really bad and destructive.  The ways that ROS work within cells is not linear and difficult to study.  Not a whole lot is known about ROS or how they affect human health.  The article, “Exercise-Induced Oxidative Stress: Cellular Mechanisms and Impact on Muscle Force Production” has a really nice over-view of various ROS and their effects.  It’s easier to think of them as different  alcoholic drinks though.  Some are beer – pretty benign unless you have a ridiculous amount of them.  Others are potent – more like Everclear – and they can do a lot of damage to you quickly.

Fenton Reaction:  “Iron(II) is oxidized by hydrogen peroxide to iron(III), forming a hydroxyl radical and a hydroxide ion in the process. Iron(III) is then reduced back to iron(II) by another molecule of hydrogen peroxide, forming a hydroperoxyl radical and a proton. The net effect is a disproportionation of hydrogen peroxide to create two different oxygen-radical species, with water (H+ + OH–) as a byproduct.”  Basically, iron can “donate or accept free electrons via intracellular reactions and help in creating free radicals.”  Free radicals are ROS.  Some of the nastiest ROS are created in the Fenton Reaction – hydroxyl radicals and hydroperoxyl radicals.  (“Exercise-Induced Oxidative Stress: Cellular Mechanisms and Impact on Muscle Force Production” has good info on both of those.)

Type II topoisomerases, gyrase and topoisomerase IV:  “Type II topoisomerases maintain DNA topology and solve the topological problems associated with DNA replication, transcription, and recombination (20). Gyrase introduces negative supercoils into DNA (21), whereas topo IV relaxes DNA and participates in chromosome partitioning (22). Chromosomal topology in Escherichia coli is maintained homeostatically by the opposing activities of topoisomerases that relax DNA (topo I and topo IV) and by gyrase.” (from “The Fluoroquinolone Levofloxacin Triggers the Transcriptional Activation of Iron Transport Genes That Contribute to Cell Death in Streptococcus pneumonia”)

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You got all that?  Even the definitions are difficult.  Now onto some highlights of the article, “The Fluoroquinolone Levofloxacin Triggers the Transcriptional Activation of Iron Transport Genes That Contribute to Cell Death in Streptococcus pneumonia.”

Basically, the researchers found that levofloxacin upregulated genes that are involved in iron uptake and triggered the Fenton reaction in certain bacteria.  The increase in reactive oxygen species that ensued contributed to the lethality of the levofloxacin.

There are a few interesting things that should be noted about this.  First, levofloxacin can upregulate genes.  How consequential is this?  Can eukaryotic genes be upregulated, or can only bacterial genes be upregulated?  What about mitochondrial genes?  What does upregulation of bacterial, mitochondrial and even eukaryotic nuclear genes do to the person who has taken levofloxacin?

Some interesting research is being conducted about the relationship between the microbiome and genetic, heritable traits.  This National Geographic article, “The Most Heritable Gut Bacterium is… Wait, What is That?” notes some of the relationships that are being explored.  Our genes can affect our microbiome, our microbiome can affect our genes, can the genes of our microbiome affect…. US?  Where does the microbiome stop and where do we begin?  Those are all questions that have not yet been answered.  Unfortunately, fluoroquinolones, like levofloxacin, are thoroughly messing up our microbiomes and even causing the upregulation/expression of certain genes.

The second thing of note from the article is that the upregulated genes caused the activation of the Fenton reaction in the bacterial cells.  Again, how does this affect our microbiome?  How does it affect US?  Hydroxyl radicals and superoxide anions are nasty ROS that damage everything in their wake.  What happens to the health of the microbiome, and the host (the person) when their gut is suddenly full of toxic ROS?  Leaky gut syndrome?  Autoimmune reactions?  The multi-symptom, chronic illness that is fluoroquinolone toxicity syndrome?

There is quite a bit of evidence that fluoroquinolones do to mitochondria what they do to bacteria – disrupt the process of DNA replication and reproduction and lead to destruction and cell death.  I think that mitochondrial destruction has a lot to do with fluoroquinolone toxicity.  However, I don’t think that the role of disruption of our microbiome and destruction of our gut bacteria should be overlooked.  The signaling that goes on within our microbiome, and between “us” and our microbiome, is critically important and poorly understood.  Triggering bacterial DNA destruction and death, upregulation of genes and the Fenton reaction – which leads to production of highly destructive ROS, is a very, very, very bad idea – even if it just stays within the microbiome.

The conclusion of “The Fluoroquinolone Levofloxacin Triggers the Transcriptional Activation of Iron Transport Genes That Contribute to Cell Death in Streptococcus pneumonia” is that:

“In conclusion, we have shown for the first time that fatDCEB transcription is regulated by the supercoiling level. The primary effect of the interaction of LVX-topo IV is the upregulation of the operon by local increase in DNA supercoiling. This upregulation would increase the intracellular level of iron, which activates the Fenton reaction, increasing the concentration of hydroxyl radicals. These effects were observed before the inhibition of protein synthesis mediated by LVX. All these effects, together with the DNA damage caused by the inhibition of topo IV, would account for LVX lethality. The possibility to increase FQs’ efficacy by elevating the levels of intracellular ferrous iron remains open.”

Because, apparently, seeing the big picture of the symbiotic relationship between the microbiome and the rest of the organism (the person), isn’t the goal.  The goal is to kill bacteria.  It’s ridiculously short sighted.  Sigh.

Because we’re in Floxieville, there has to be a paradox.  Supplementing iron helped me more than just about anything else.  Iron is one of the few supplements that made me feel markedly better immediately after taking it.  Other Floxies have reported that their ferritin levels are low post-flox.  The role of the Fenton reaction in fluoroquinolone toxicity would lead one to think that iron should be the last thing that a Floxie might need or want.  It helped me though.  I had more energy and even my tendons felt better when I started supplementing iron.  I don’t know if this has something to do with the kind of iron in my supplement/body – FE3 or FE2 – or if the iron had been converted to other chemical compounds and I needed to replace it, or what.  I do know that, as I said in the beginning of this post, this stuff is hard.

The Fluoroquinolone Levofloxacin Triggers the Transcriptional Activation of Iron Transport Genes That Contribute to Cell Death in Streptococcus pneumonia provides a good description of how fluoroquinolones work:

“The killing effect of FQs has been related to the resolution of reaction intermediates of DNA-FQ-topoisomerase complexes, which generates irreparable double-stranded DNA breaks (31). This could occur in E. coli by two pathways, one dependent on protein synthesis and the other independent of it. It has been shown that hydroxyl radical action contributes to FQ-mediated cell death occurring via a protein-dependent pathway (32). This result agrees with a recent proposal suggesting that, following gyrase poisoning, hydroxyl radical formation utilizing internal iron and the Fenton reaction (33) is generated and contributes to cell killing by FQs (34) as well as by other bactericidal antibiotics (35, 36). In this mechanism, proposed for Enterobacteriaceae (35, 37), the primary drug interactions stimulate oxidation of NADH via the electron transport chain that is dependent on the tricarboxylic acid cycle. Hyperactivation of the electron transport chain stimulates superoxide formation. Superoxide destabilizes the iron-sulfur clusters of enzymes, making Fe2+ available for oxidation by the Fenton reaction. The Fenton reaction leads to the formation of hydroxyl radicals that would damage DNA, proteins, and lipids (38), which results in cell death. Instead of a generalized oxidative damage, a recent study supports that the main action of hydroxyl radicals is the oxidation of guanine (to 8-oxo-guanine) of the nucleotide pool. The incomplete repair of closely spaced 8-oxo-deoxyguanosine lesions caused lethal double-strand DNA breaks, which would underlie much of the cell death caused by beta-lactams and FQs (39). However, recent investigations have questioned the role of hydroxyl radicals and intracellular iron levels in antibiotic-mediated lethality using antibiotic concentrations either similar to (40) or higher than (41) those used previously. The disparate results obtained using diverse antibiotic concentrations and times of treatment emphasize the complexity of the lethal stress response (42).”

Similar destruction happens in mitochondria.  As I mentioned though, even if it didn’t happen in mitochondria, and only happened in bacteria, that destruction and those reactions are horrible things to do to a person’s microbiome.  It is, after all, part of us.

All of the people at the FDA who think that it’s okay not to strictly regulate drugs that disrupt the process of DNA replication and reproduction, and lead to the upregulation of genes and induction of the Fenton reaction, which leads to high levels of highly reactive ROS, should be fired.  I’ve learned enough biochem in the last 3 years to know that induction of the Fenton reaction in any part of the body is a really bad idea.  The scientists at the FDA should be able to figure this out.

 

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Shades of Grey – The Good and Bad of Fluoroquinolones

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Here is a new post about fluoroquinolones on Hormones Matter –

Shades of Grey – The Good and Bad of Fluoroquinolones

From it –

“Fluoroquinolones can do good, but they can do harm too. Categorizing things in terms of good or bad is the natural inclination of most people, but it’s never that simple for drugs. All drugs can do good, but they can do harm too – hence the list of side-effects that comes with each prescription. We can’t yet ask for drugs to only do good, and never do harm – that’s not the way the world works. But we can ask for dangerous drugs to be used appropriately. It is ONLY appropriate for fluoroquinolones to be used in life-or-death situations when other antibiotics aren’t effective. To use them flippantly, and when they aren’t entirely necessary, is inappropriate and a violation of the Hippocratic Oath.”

I hate that cipro hurt me.  I hate that fluoroquinolones hurt any of us.  But I still don’t think that they should be banned entirely.  It is not unreasonable to demand that they be used sensibly though.  The amount of collateral damage done by FQs is unacceptable.  Collateral damage should be minimized.  It’s not too much to ask for.

 

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Antibiotics After Fluoroquinolone Toxicity

People often ask about what they should do to treat infections post-flox.  Here are my tips.

First, please INSIST on getting your infection cultured and confirmed before you take any antibiotics.  As anyone who has had an adverse reaction to an antibiotic can tell you, antibiotics are not benign drugs.  They have side-effects (HERE is the 43 PAGE warning label for Cipro/Ciprofloxacin).  Some of those side-effects are life-altering and/or life-threatening.  You don’t want to put any drugs into your body unless you absolutely need them.  A culture should be done to confirm that an infection is present before you take an antibiotic – no matter what.

Because antibiotics have been shown to wreak havoc on the microbiome and bactericidal antibiotics damage mitochondria – and because both microbiome disruptions and mitochondrial dysfunctions are linked with every chronic disease there is – I highly recommend looking into some non-pharmaceutical options first.  Garlic has been shown to have antibiotic qualities and to be more effective against biofilms than many antibiotics.  For urinary tract infections, D-mannose has effectively helped thousands of people get rid of their infection.  Some other non-pharmaceutical remedies for urinary tract infections can be found HERECoconut oil has been shown to have anti-bacterial qualities and it may be good for treating skin and GI infections.  Colloidal silver not only has anti-bacterial qualities on its own, it also has been shown to increase the effectiveness of pharmaceutical antibiotics when used in conjunction with them.  Andrographis is an herb that has antibiotic qualities.

If non-pharmaceutical options aren’t working and you need an antibiotic to get rid of your confirmed infection, here are the antibiotics that I recommend along with reasons as to why I recommend them (or not).

  1. Most Floxies seem to do well with doxycycline and other tetracyclines. Tetracyclines are bacteriostatic antibiotics that, “stops bacteria from multiplying but does not kill them.” (source)
  2. Several Floxies have taken Z-pack’s without incident
  3. Amoxicillin seems to be about as benign as antibiotics get. So, it’s not harmless, but it’s well tolerated generally.
  4. Penicillin seems to be well tolerated – unless you’re allergic to it.
  5. Cephalosporins seem to be well tolerated

There are probably some other antibiotics that are fine for Floxies, I just haven’t heard about them.  Please feel free to leave a comment below if there is an effective and relatively safe one that I’m missing.

Here are the antibiotics that I recommend avoiding because they have side-effects that are similar to those of fluoroquinolones, and because many Floxies react badly to them –

  1. Macrobid / Nitrofurantoin
  2. Flagyl / Metronidazole
  3. Bactrim / Trimethoprim / Sulfamethoxazole
  4. Augmentin

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Fluoroquinolones – Cipro/Ciprofloxacin, Levaquin/Levofloxacin, Avelox/Moxifloxacin, Floxin/Ofloxacin and a few others – should be avoided entirely unless you are dying and make the decision that getting “floxed” is preferred to death.  Every warning label for every fluoroquinolone says that people who have an existing hypersensitivity to a fluoroquinolone should not take them again.  “Ciprofloxacin is contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antimicrobial agents, or any of the product components.” (Warning Label)

Before you take an antibiotic, or any pharmaceutical for that matter, I highly recommend that you look up the review for that drug on http://www.askapatient.com/ and look it up on http://www.peoplespharmacy.com/.  Also, look up the drug’s warning label.  Be informed.  Make an informed decision.

Here is a list of antibiotics – http://en.wikipedia.org/wiki/List_of_antibiotics  I didn’t get close to going through all of them.  But I hope that this post gives you some guidance when/if you are faced with an infection.

I’m not a doctor, so please take this advice for what it’s worth.  Doctors should be consulted when you have an infection.  The internet should be consulted too though, because doctors aren’t capable of knowing everything and informed consent is really important.

 

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Crowdfunding Floxie Hope

Floxie.Hope.1800.72.dpi

I’m asking for support of Floxie Hope.  Thank you very much for your consideration!

I’m trying crowd-funding.  The basic premise of crowd-funding is that many people each give a little money to support a cause or organization because they find value in it.

I’m a bit biased, but I think that a lot of value is offered through Floxie Hope.  The stories of healing and recovery offer hope and tips to those going through the horror of fluoroquinolone toxicity. The posts offer information that Floxies can share with their families and friends to help spread the word about the dangers of fluoroquinolones. The posts also help friends and family members to understand what is experienced when the fluoroquinolone toxicity bomb goes off in a Floxie’s body.  The Links & Resources page links to articles explaining the science behind fluoroquinolone toxicity – and gives Floxies something that they can show to their doctors to help them to understand what is happening in the Floxie’s body.  People have reached me through the “contact me” link and I hope that I have helped them through offering guidance and support.

I hope that everyone who visits Floxie Hope gains knowledge, strength, community, information, support, and even amusement.  I hope that it makes the journey through fluoroquinolone toxicity a little bit easier to bare.

If you would like to support Floxie Hope, here is a link to support Floxie Hope monetarily:

 

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Additionally, there are lots of non-monetary ways that you can support Floxie Hope.  I greatly appreciate everyone who:

  1. Shares posts and articles about fluoroquinolone toxicity on social media
  2. Comments on Floxie Hope (a huge THANK YOU to everyone who has helped to form a community of support on Floxie Hope)
  3. Talks to your friends and family about the dangers of fluoroquinolones

It’s a good site.  If you agree, please donate a few dollars through the link above, spread the warning to those you love, and/or spread the hope to those who are suffering.

Thank you for your time, consideration and support – in whatever form it takes!

Wishing you hope and healing,

Lisa

 

P.S. – If you are in a giving mood, here are some other organizations that are providing value to the Floxie community, who will also appreciate support/money:

 

 

Fluoroquinolones Surpass Vioxx and Thalidomide in Harm Done

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In a May, 2014 letter to the U.S. SenateDoctor Jay S. Cohen said of fluoroquinolones, “In my 40+ years in pharmacovigilance, FQs (fluoroquinolones) surpass Vioxx and Thalidomide in the degree of permanent harm done.”  Let that sink in for a bit.

Fluoroquinolones – cipro/ciprofloxacin, levaquin/levofloxacin, avelox/moxifloxacin and floxin/ofloxacin – drugs that are seen as simple antibiotics (though they do severe cellular harm and are more appropriate for use as chemotherapy drugs), that are prescribed more than 20 million times per year in the U.S. alone – are doing more harm than Vioxx – a drug that led to more than 140,000 American heart attacks, and Thalidomide – a drug that has caused birth-defects and deaths of thousands of children world-wide.

Vioxx has been removed from the market, and the use of Thalidomide is severely restricted.  Fluoroquinolones, on the other hand, are prescribed with abandon, despite the fact that hundreds of studies have shown that they do severe cellular damage and thousands of patients have filed reports with the FDA noting that a variety of severe health problems have been experienced after taking a fluoroquinolone.

Transgenerational Side-Effects

I have argued that fluoroquinolones have transgenerational ill effects and that children are suffering because of the epigenetic effects of fluoroquinolones (HERE and HERE).  I have never hoped to be wrong about anything more than my assertions that fluoroquinolones are related to autism, but the possibility exists – because we really don’t know what the transgenerational effects of microbiome destruction and depletion of mitochondrial DNA are – and fluoroquinolones do, indeed, both obliterate the microbiome and deplete the only non-redundant form of DNA that we have – mitochondrial DNA.  (1)………………………………..

READ MORE ON COLLECTIVE EVOLUTION

http://www.collective-evolution.com/2014/06/25/these-popular-antibiotics-are-prescribed-to-millions-every-year-they-have-detrimental-effects-everyone-needs-to-be-aware-of-this/

 

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Adverse Drug Reactions are Like Earthquakes

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Here is a post about how adverse drug reactions are like Earthquakes –

http://www.hormonesmatter.com/adverse-drug-reactions-like-earthquakes/

Drugs, just like earthquakes, can shake your world and cause damage and destruction.

 

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Epigenetics and Fluoroquinolones: Now What?

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Per Dr. Chandler Marrs (who runs www.hormonesmatter.com), “Above and around genetic codes reside the on/off switches to many processes (the switching of genes on and off is epigenetics). If common medications, including fluoroquinolones, up or downregulate these processes and create new diseases, what is someone who takes them supposed to do? Can epigenetic changes be reversed? What is the patient to do with all the recent research on epigenetics? The research is all well and good, but what does it mean to the patient?”

Indeed.

Here is a post about how fluoroquinolones, and other common pharmaceuticals, affect epigenetics. There are currently more questions than answers and the right path is far from clear.

https://www.hormonesmatter.com/epigenetics-common-medications/

 

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Articles About Fluoroquinolone Toxicity to Give to Your Doctor

People often ask for articles about fluoroquinolone toxicity to share with their doctors.  Following are a few articles that I recommend.

What you should share with your doctor depends on your doctor’s willingness to read what you give him or her.  Doctors are busy.  Most of them don’t have the time, energy or inclination to keep up with all of the latest drug research.  They depend on the FDA to regulate drugs and they assume that if a drug has been on the market for years, it must be safe.  They are wrong in those assumptions.  It would be more appropriate for them to assume that all of the mysterious diseases of modernity (fibromyalgia, chronic fatigue syndrome / M.E., autoimmune diseases, allergies, dietary intolerances, autism, etc.) are due to the damage that pharmaceuticals are doing to the mitochondria, microbiome, endocrine system, etc.; and the feedback loops between those delicate systems.  Unfortunately, most doctors haven’t had that epiphany quite yet.  Here are some articles that can at least introduce Fluoroquinolone Toxicity Syndrome to them:

Show your doctor this if 4 sentences is his/her limit:

I’m going to ruffle feathers, but I’ll tell you anyway” By Suzy Cohen

SuzyCohen

Here are more details on fluoroquinolones being chemo drugs, as Suzy Cohen notes: “ CIPRO, LEVAQUIN AND AVELOX ARE CHEMO DRUGS” by me (Lisa Bloomquist) on Hormones Matter.

For doctors who are willing to take the time to read a few articles, but aren’t going to spend a lot of time looking into FQ toxicity, I recommend that you show them these:

  1.  Dear Doctor letter written by Dr. Plumb, a doctor who was Floxed
  2. New York Times article by Jane Brody, “Popular Antibiotics May Carry Serious Side Effects
  3. PBS Frontline expose about fluoroquinolones
  4. Forbes article by Melanie Haiken, “Antibiotic Alert: The Drug the Doctor Ordered Could Cause Deadly Side Effects
  5. Fluoroquinolones 101” by me (Lisa Bloomquist) on Hormones Matter.

For doctors who are willing to read journal articles about fluoroquinolones, I recommend these:

  1. Physical Medicine and Rehabilitation (PM & R) “Musculoskeletal Complications of Fluoroquinolones: Guidelines and Precautions for Usage in the Athletic Population
  2. Science Translational Medicine, “Bactericidal Antibiotics Induce Mitochondrial Dysfunction and Oxidative Damage in Mammalian Cells
  3. Journal of Young Pharmacists, “Oxidative Stress Induced by Fluoroquinolones on Treatment for Complicated Urinary Tract Infections in Indian Patients
  4. Molecular Pharmacology, “Delayed Cytotocicity and Cleavage of Mitochondrial DNA in Ciprofloxacin Treated Mammalian Cells

There are more than 100 other useful peer-reviewed research articles on the Links & Resources page of Floxie Hope.

Another thing that you can do is go over the FDA warning labels for the fluoroquinolones with your doctor:

  1. FDA Datasheet – Ciprofloxacin (Cipro)
  2. FDA Datasheet – Levofloxacin (Levaquin)
  3. FDA Datasheet – Moxifloxacin (Avelox)

The severity of adverse reactions to fluoroquinolones isn’t noted anywhere on the labels.  Nor is the fact that symptoms can be delayed.  It is assumed, by everyone, that adverse drug reactions are transient and that they will stop when administration of the drug has stopped.  This isn’t true for fluoroquinolones.  The adverse effects listed on the fluoroquinolone warning labels are multi-systemic and perhaps your doctor should wonder how and why fluoroquinolones cause multi-symptom, chronic illness.

Most people, doctors and patients alike, think that adverse reactions to fluoroquinolones are rare.  If you feel like going over this post with your doctor, I think that I make some good points in it:  “Is Fluoroquinolone Toxicity Rare?

Multi-symptom chronic illness brought on by a chemotherapy drug masquerading as an antibiotic is something to take seriously.  If your concerns are not taken seriously, I highly recommend finding another doctor.

And please thank the doctors who listen to you, read the articles that you give them and start being more prudent with their use of fluoroquinolones.  When a critical mass of doctors realize the dangers of these drugs, we’ll start seeing change.  I thank every one of you who takes the time to talk to your doctors about fluoroquinolone toxicity.  It does a lot of good.

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Don’t take Cipro, Levaquin or Avelox if….

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Post on Hormones Matter –

http://www.hormonesmatter.com/dont-take-cipro-levaquin-avelox-fluoroquinolone-toxicity/

In an ideal world, fluoroquinolones would be reserved for use in life-or-death situations. Until then, and until medicine can be completely customized and individualized, these groups of people should avoid fluoroquinolones:

1.  People who have reacted badly to a fluoroquinolone in the past.

2.  Athletes.

3.  People on steroids (corticosteroids).

4.  People who need to take NSAIDs regularly.

5.  Immunocompromised Individuals.

6.  People with Mitochondrial Dysfunction.

7.  Children.

 

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Conflicting Study Results: Do DNA Breaks Hold Answers?

There is a lot of conflicting information about fluoroquinolone antibiotics (Cipro, Levaquin, Avelox, Floxin and a few others) noted in scientific journals.  One study will conclude one thing about how fluoroquinolones effect human cells and another study will reach the opposite conclusion.  It’s frustrating for everyone involved and it leads to the conclusion, that is also noted in most journal articles about fluoroquinolones, that, “Despite their widespread application, the exact mechanism of action of the quinolones is not fully understood.” (1)  Despite the fact that the exact mechanism of action of fluoroquinolones is unknown, shouldn’t some of the details of their effects on human cells be known?  Shouldn’t there be some clarity in how these drugs affect cells, if not how they work or sometimes don’t work?  Basic, verifiable, answers are sought, but they remain elusive.  Some interesting, and possibly useful, information may be found in examining why clear answers are so difficult to obtain.

Shouldn’t it be testable whether fluoroquinolones increase or decrease levels of Reactive Oxygen Species (ROS)?  Shouldn’t the question of whether fluoroquinolones increase or decrease cellular inflammation be verifiable?  Shouldn’t Scientists know whether fluoroquinolones activate or inhibit t-cell gene expression?  These things can be studied in laboratories.  Answering these questions doesn’t require long-term studies, surveys that are subject to interpretation or vague definitions.  They should be answerable questions and the answers should be clear.  It’s science, not philosophy.  The answers should be black or white, yes or no, not shades of grey.

Yet with each of these questions there are multiple conflicting reports.  No one seems to be able to consistently verify what happens to human cells when they are exposed to fluoroquinolones.  Some studies done by well-run institutions and published in reputable journals say that fluoroquinolones decrease ROS, reduce inflammation and inhibit t-cell gene expression (2).  Other articles in equally well-respected journals say the opposite (3, 4, 5, 6).  So which is true?  Does the arrow go up or down?  I’m sure that answering these questions isn’t easy, but they should be answerable and the answers should be the same each time an experiment is done, right?

So why are there differing answers?  Why can’t Scientists, many of whom are undoubtedly brilliant and capable, figure this out?  A couple of possible answers are that one group of Scientists’ methods are wrong, or that cells react differently to fluoroquinolones with each exposure.  Both possibilities are fascinating on some level.  If the methodologies of one group of Scientists produce an anti-inflammatory response within cells, but the methodologies of another group of Scientists produce an inflammatory response within cells, perhaps the difference in methodologies holds the key to limiting an inflammatory response in living humans.  A cure, or an antidote to the inflammation that is definitely experienced by some people having an adverse reaction to fluoroquinolones, may be revealed from the study methodologies in which an anti-inflammatory response was induced/observed.

An even more interesting possibility is that how cells react to fluoroquinolones depends on which strand of DNA the quinolone molecules attach to.  Studies have found that fluoroquinolones form a poisonous adduct to DNA (7, 8).  Perhaps the reaction of the cell in response to exposure to fluoroquinolones depends on which DNA strands are broken, where they’re broken and where the quinolone molecule attaches to the DNA.  It is plausible that there are some places where DNA could be broken and adducted to that would create an inflammatory response and there are other places where DNA could be broken and adducted to that would create an anti-inflammatory response.  I have neither the tools nor the expertise to test this hypothesis, but from the perspective of someone who has been studying adverse reactions to fluoroquinolones for the past 2 years, the notion that fluoroquinolones break and attach to DNA makes sense of many perplexing aspects about fluoroquinolone toxicity.  If we assume that DNA breaks and quinolone adduction to DNA is behind adverse reactions to fluoroquinolones, the following questions may have the following answers:

Why are some people adversely affected by fluoroquinolones while others aren’t?  Potential answer – some people have important strands of DNA affected while other people have unimportant strands of DNA affected.  And/Or, some people have DNA affected that triggers and inflammatory response and the over-production of ROS, while others don’t because their DNA is broken in less consequential spots.

Why could I handle Cipro for 3 prescriptions but the 4th prescription hurt me?  Potential answer – the Cipro affected inconsequential strands of DNA the first 3 times it was administered, but it damaged an important strand of DNA the 4th time it was administered.

Why did I experience a delayed adverse reaction to Levaquin?  Potential answer – it takes time for damaged DNA to replicate.

Why can’t anyone seem to figure out how these drugs work?  Potential answer – because the human genome is not fully mapped out and most Researchers aren’t looking at how fluoroquinolones affect DNA.

I’m not a Scientist.  I certainly could be wrong about the above hypothesis.  But I do find it both frustrating and interesting that Scientists, who are undoubtedly smarter than I am, can’t seem to figure out some basic facts about how fluoroquinolones work.  I think that there are some answers in their inability to find clear answers.  I suspect that the answers lie in quinolone adducts to DNA.  Perhaps someone with the tools to determine whether I’m right or wrong will design an experiment (that is consistently verifiable) to determine the effects of fluoroquinolones on DNA, and to determine whether or not DNA damage results in differing effects of the drugs.

Sources:

  1. Inorganic Chemistry, “New uses for old drugs: attempts to convert quinolone antibacterials into potential anticancer agents containing ruthenium.
  2. The Journal of Immunology, “Mitochondrial Reactive Oxygen Species Control T Cell Activation by Regulating IL-2 and IL-4 Expression:  Mechanism of Ciprofloxacin Mediated Immunosuppression
  3. The Tohoku Journal of Experimental Medicine, “Fluoroquinolone Induced Tendinopathy: Etiology and Preventative Measures
  4. Nepal Medical College Journal, “Genotoxic and cytotoxic effects of antibacterial drug, ciprofloxacin, on human lymphocytes in vitro”
  5. Journal of Young Pharmacists, “Oxidative Stress Induced by Fluoroquinolones on Treatment for Complicated Urinary Tract Infections in Indian Patients
  6. Science Translational Medicine, “Bactericidal Antibiotics Induce Mitochondrial Dysfunction and Oxidative Damage in Mammalian Cells
  7. The Journal of Biological Chemistry, “The Mechanism of Inhibition of Topoisomerase IV by Quinolone Antibacterials.”
  8. Proceedings of the National Academy of Sciences of the United States, Biochemistry, “Quinolone Binding to DNA Mediated by Magnesium Ions”

 

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Doctor Referral List

Several people have asked me for referrals to doctors who specialize in Fluoroquinolone Toxicity.  Unfortunately, there are very few doctors who claim any expertise in Fluoroquinolone Toxicity (I say claim because even the most in-depth medical journals say that the mechanisms through which fluoroquinolones work, and sometimes don’t work, are unknown at this time).  But there are doctors who have read-up on fluoroquinolone toxicity, who are familiar with the issues of Floxies, who are willing and able to listen and to help, when possible.  Here is a list of the doctors who have been identified thus far –

 

https://docs.google.com/spreadsheets/d/10HdvKMTV1YGPyubf9KCYivtG8i2jo8w1kZjBDjNdt38/edit#gid=7

 

If you find a good doctor that you like who you would like to refer other Floxies to, please add the doctor, or other medical professional that helps you, to the referral list –

 

https://docs.google.com/forms/d/e/1FAIpQLSeSLS4uxb4P8g05Jo7MomnuLle9qGaIPValUL22v-AKwuXy6Q/viewform

 

I did not create these google documents.  I want to thank the person who did (I’m not sure who that person is, sorry).  Thank you for putting this together!

 

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Antioxidant Depletion by Fluoroquinolones

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One of my favorite journal articles about the adverse effects of fluroquinolones is Oxidative Stress Induced by Fluoroquinolones on Treatment for Complicated Urinary Tract Infections in Indian Patients written by V. Talla and P.R. Veerareddy and published in the Journal of Young Pharmacists.  It’s a pretty damning article and it’s easy to read.  I highly recommend that you read it yourself.  Here is the link –

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3249743/?report=printable

Even though it’s written at a level that most people can understand, there are a few terms that I’m assuming aren’t known by the average person reading this blog.  So, I have taken the main points from the study, as I see them, and explained them to the best of my ability.  Basically, I did the Google and Wiki look-ups so you don’t have to.

Here are the main points of the article:

1. “There is a significant and gradual elevation of lipid peroxide levels in patients on ciprofloxacin and levofloxacin dosage regimen but not with gatifloxacin.” What is lipid peroxide and do we want our levels to be high or low?  Wikipedia tells us that, “Lipid peroxidation refers to the oxidative degradation of lipids. It is the process in which free radicals “steal” electrons from the lipids in cell membranes, resulting in cell damage.”  (1)  Basically, lipid peroxidation is not something you want going on in your body.  You don’t want your lipids to be degraded via oxidation.  You don’t want cell damage.  Drugs that significantly increase levels of lipid peroxide are hurting you – at least on that level.


2. “There was substantial depletion in both SOD and glutathione levels particularly with ciprofloxacin.”  Superoxide dismutases (SODs) “are enzymes that catalyze the dismutation of superoxide (O2−) into oxygen and hydrogen peroxide. Thus, they are an important antioxidant defense in nearly all cells exposed to oxygen.” (2)  Additionally, “Within a cell, the superoxide dismutases (SODs) constitute the first line of defence against ROS.” (3)  SOD is “Present both inside and outside cell membranes, SOD is one of the body’s primary internal anti-oxidant defenses, and plays a critical role in reducing the oxidative stress implicated in atherosclerosis and other life-threatening diseases. Studies have shown that SOD can play a critical role in reducing internal inflammation and lessening pain associated with conditions such as arthritis.” (4) SODs are necessary for neutralizing the oxidative damage done by reactive oxygen species (ROS) (more on ROS below).

Glutathione is also depleted by fluoroquinolones.  Per Dr. Mark Hyman, Glutathione is “the most important molecule you need to stay healthy and prevent disease.”  (5)  Dr. Hyman notes that glutathione depletion “leaves you susceptible to unrestrained cell disintegration from oxidative stress, free radicals, infections and cancer.  And your liver gets overloaded and damaged, making it unable to do its job of detoxification.”  Glutathione is an extremely important antioxidant.

SOD and glutathione work together to neutralize oxidative damage done by ROS.  Here is a brief description of how SOD and glutathione work together:

SOD is responsible for catalyzing the conversion of superoxide to elemental oxygen and hydrogen peroxide. This transformation is called dismutation, hence the enzyme’s name. Although hydrogen peroxide is also a pro-oxidant compound, it is subsequently converted by the enzymes catalase and glutathione peroxidase to simple water and oxygen. (4)

Without the proper amount of SOD or glutathione in your body, ROS will wreak havoc on your system, causing oxidative stress and damage to every bodily system.   

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3. “On the 5th day of treatment, plasma antioxidant status decreased by 77.6%, 50.5%, 7.56% for ciprofloxacin, levofloxacin and gatifloxacin respectively.”  Antioxidants are molecules “that inhibit the oxidation of other molecules. Oxidation is a chemical reaction that transfers electrons or hydrogen from a substance to an oxidizing agent. Oxidation reactions can produce free radicals. In turn, these radicals can start chain reactions. When the chain reaction occurs in a cell, it can cause damage or death to the cell.” (6)  Oxidation is bad, antioxidants are good, cell death is bad – we want plasma antioxidant levels to be high, not low.  Decreasing plasma antioxidant status is bad for your health on a cellular level.

4. “In conclusion ciprofloxacin and levofloxacin induce more reactive oxygen species that lead to cell damage than gatifloxacin.”  The researchers also note that, “Several in vitro and in vivo study using animals revealed that fluoroquinolones induced oxidative stress by producing reactive oxygen species (ROS).”  ROS are described as follows:

Without oxygen, we could not exist. However, in the process of generating energy by “burning” nutrients with oxygen, certain “rogue” oxygen molecules are created as inevitable byproducts. Known as free radicals and reactive oxygen species, these unstable, highly reactive molecules play a role in cell signaling and other beneficial processes when they exist in benign concentrations.  But when their numbers climb, as may occur as a result of aging and other conditions, they may wreak havoc with other molecules with which they come into contact, such as DNA, proteins, and lipids. As such, these “pro-oxidant” molecules become especially toxic.

In fact, a prevailing theory of disease and aging states that the gradual accumulation of pro-oxidant molecules, and the harm they incur, is responsible for many of the adverse changes that eventually cause various diseases. These include cancer (possibly triggered by free radical-induced damage to cellular DNA) and inflammatory and degenerative diseases such as Alzheimer’s, arthritis, atherosclerosis, and diabetes. While scientists have not yet reached consensus on the topic, accumulated evidence overwhelmingly identifies increased oxidative stress with age as a source of damage to cellular structure and function.  (4)

Additionally, the wikipedia article on ROS does a nice job of explaining the damage that ROS can do – http://en.wikipedia.org/wiki/Reactive_oxygen_species

5. The authors of the study also note that, “The efforts of the endogenous antioxidant enzymes like SOD to remove the continuously generated free radicals initially increase due to an induction but later enzyme depletion occurs by 73.3% and 32.2% for ciprofloxacin and levofloxacin respectively, resulting in oxidative cell damage. Hence when the generation of reactive free radicals overwhelms the antioxidant defence, lipid peroxidation of the cell membrane occurs. This causes disturbances in cell integrity leading to cell damage/death. In the present study the repeated administration of CFX (ciprofloxacin) (recommended dosage regimen of CFX for UTI) resulted in increase free radical adduct generation by CYP450 mediated metabolism that cumulate and may result in increased ROS and substantial reduction in antioxidant defense.”

I think it’s a pretty damning article.  It’s easy to read and understand.  It doesn’t answer all questions about the damage done by fluoroquinolones, but it does a nice job at describing some of the issues that go on in the body when fluoroquinolones are ingested.  I suggest that you bring a copy to your next doctor’s appointment.

Sources:

  1. http://en.wikipedia.org/wiki/Lipid_peroxidation
  2. http://en.wikipedia.org/wiki/Superoxide_dismutase
  3. Alscher RGErturk NHeath LS., “Role of superoxide dismutases (SODs) in controlling oxidative stress in plants” Journal of Experimental Botany 2002 May; 53(372):1331-41. http://www.ncbi.nlm.nih.gov/pubmed/11997379
  4. Dale Keifer, “Superoxide Dismutase Boosting the Body’s Primary Antioxidant Defense” Life Extension Magazine.  June, 2006 http://www.lef.org/magazine/mag2006/jun2006_report_sod_01.htm
  5. Mark Hyman, MD, “Glutathione:  The Mother of All Antioxidants” 04/10/2010 http://www.huffingtonpost.com/dr-mark-hyman/glutathione-the-mother-of_b_530494.html
  6. http://en.wikipedia.org/wiki/Antioxidant

 

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Fluoroquinolone Antibiotics and Nerve Damage/Malfunction

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This post about how fluoroquinolones are associated with Central, Peripheral and Autonomic Nervous System Damage was published on Hormones Matter on 09/09/2013.  

http://www.hormonesmatter.com/fluoroquinolone-antibiotics-associated-with-nervous-system-damage/

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Fluoroquinolones 101

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I wrote the following article for Hormones Matter:

http://www.hormonesmatter.com/fluoroquinolones-101-antibiotics-to-avoid/

Thanks for reading it!

-Lisa

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Adverse Reactions to Fluoroquinolone Antibiotics and Gardasil

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I wrote an article for another web site, Hormones Matter about what Gardasil and Fluoroquinolones have in common.  Here’s the article –

http://www.hormonesmatter.com/fluoroquinolone-antibiotics-gardasil/

Here are some tragic stories of how young women have been hurt by Gardasil –

http://www.hormonesmatter.com/life-of-alexis-wolf-post-gardasil/

http://www.hormonesmatter.com/five-years-after-gardasil/

http://www.hormonesmatter.com/before-and-after-gardasil/

http://www.hormonesmatter.com/day-in-the-life-post-gardasil/

These stories matter.  These young women deserve to be heard.  Please read their stories with an open mind and heart.

Thank you.

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Is Our Meat Floxed?

My favorite theory about the pathology/cause of floxing (of course, fluoroquinolone use is the CAUSE of floxing, but not all people who use fluoroquinolones get floxed – something goes horribly wrong in the bodies of the people who do), is that a neurotoxin is produced by the damaged bacteria within the body and that neurotoxin is the actual cause of the health problems that Floxies experience. More information on this theory can be found on https://floxiehope.com/2013/06/20/test-post/ and at the bottom of this page.

This theory, that neurotoxins are produced when fluoroquinolones mess up the bacteria, makes me think about a lot of things. One of these things is our meat.

Fluoroquinolones are used rampantly in agriculture, even though there has been some regulation limiting their use. If fluoroquinolones cause the production of neurotoxins, could it be possible that these neurotoxins are in the flesh of the animals that are exposed to fluoroquinolones – the meat that we eat? If so, what are the health consequences of this to the humans who eat that meat?

I believe that meat is tested for antibiotics and other agriculturally utilized pharmaceuticals before it goes to market, but if the meat is actually contaminated with a neurotoxic byproduct of the pharmaceutical, as opposed to the pharmaceutical itself, then maybe the wrong thing is being tested for. Is our meat contaminated with neurotoxic byproducts of fluorquinolone antibiotics? I don’t know, but it’s something that is definitely worth looking into.

Admittedly, this line of thinking involves a lot of unproven jumps and assumptions, but I don’t think that I’m being completely unreasonable. The theories described below seem more than reasonable, they seem right, and I think that looking into the health consequences of eating meat that is from animals that have been floxed is something that we should do. Question everything. It’ll keep you safer and make you smarter.

There are many good reasons not to use fluoroquinolone antibiotics on livestock animals. Antibiotic resistance is becoming a bigger and bigger problem and the thought that we may be breeding antibiotic resistant bacteria in our feedlots is appalling. This problem, though not without controversy, is generally acknowledged and some regulation is being put into place to try to prevent an atrocity from happening. However, humans are slow to change the status quo unless there is an emergency and I doubt that real, meaningful regulation will come about until an antibiotic resistant bacteria is bred in feedlots and that bacteria infects people. Antibiotic use in livestock also enables ranchers to keep their animals in dirty, unsanitary, inhumane conditions – something that is also appalling. Even though I haven’t done a whole lot of research into the topic, I think that with the research that has been done, we can add potential contamination with neurotoxic byproducts to the list of reasons that antibiotics generally, and fluoroquinolones specifically, should not be used in livestock.

I like meat and I eat it, but I’ve tried to exclusively consume organic meat since I got floxed. I’m going to try harder now. I suggest that you do the same.

From https://floxiehope.com/2013/06/20/test-post/

Is a neurotoxin produced by the damaged/bad bacteria after exposure to fluoroquinolones (or the die-off of the “good” bacteria that keep the bad ones in check)?  There are several interesting things noted in Beyond Antibiotics by Michael Schmidt.  Dr. Schmidt points out that both tartaric acid and tricarbalyte are noxious compounds produced by bad gut bacteria when good gut bacteria in the gut are not available to keep them in check.  Tartaric acid “is a known poison of the energy system of mitochondria,” and tricarbalyte “binds to magnesium and may reduce the availability of dietary magnesium.”  (pages 28-29) Dr. Schmidt also says that antibiotics cause the production of clostridiam which is a known neurotoxin producing organism (p. 44). And, on page 47 he says, “Whever a CPY enzyme is blocked or slowed, its ability to detoxify other drugs can be impaired.”  My thought on this is that the fluoroquinolones slowed our CPY enzymes then the NSAIDs, steroids, other toxins in our system, did other damage – and maybe that’s why each of us have so many different symptoms.

Also, John Travis reported in Science News (July 2003;164) that research performed by John F. Prescott found that certain antibiotics, such as the fluoroquinolones, the class of antibiotics that includes the name-brands and generic brands of Levaquin[R], Cipro[R], Tequin[R], and Avelox[R], actually are known to trigger a type of virus called bacteriophages (viruses that can infect bacteria) to change the genetic sequencing of the bacteria, causing the bacterium they have infected to start producing toxins. These viruses can act as genetic delivery vans, invading bacteria, such as spirochetes, often lying dormant, until activated by a change in the host (your body’s) environment. Once activated, these viruses insert their toxin-generating genes into the bacterial chromosomes. These viruses can turn basically harmless bacterium into killers through this genetic sequencing of toxins (Travis 2003).  Not only are these toxins released through bacteria die-off and not only can antibiotics actually increase the production of the toxins, but these viruses can cause the bacteria to rupture, spilling their toxins into the body (Waldor 2004).  http://www.benbrew.com/lb/lyme5.pdf

* I haven’t had the time to do a whole lot of research into this theory, so if anyone has any articles about it, please forward them on to me.

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Fixing Fluoroquinolone Toxicity is IMPORTANT!

Your health is important.  Fight for it.  Because it matters.

Your voice is important.  Scream for justice.  Because it matters.

Your life is important.  Live life like it’s important.  Because it is.

Showing others that their life matters is important.  Because it does.

Doing something, anything, and I’m honestly not sure what direction to go, about the problems associated with fluoroquinolones, is IMPORTANT.  It’s not okay that any of us were hurt by a prescription antibiotic.  There is nothing okay about that.  We are not collateral damage, we are not small numbers (of people) (of people is in parentheses because it barely matters to some – we’re numbers ) who are adversely effected by an otherwise good drug – we’re PEOPLE whose lives matter.  And it’s important that we scream and let the people and the system that is disregarding us know that WE MATTER!  It’s important for us to change the medical (and maybe the American, and maybe the world) culture that views it as okay to treat people as if they don’t matter, as if they’re collateral damage.  It’s really important.

There are children, even babies, who are given fluoroquinolones – typically in the form of ear and eye drops to treat ear infections and pink-eye.  It is our biological and moral imperative to protect our children.  And by our children, I don’t just mean our biological children, I mean all children.  IT IS REALLY IMPORTANT THAT WE PROTECT CHILDREN FROM THESE DRUGS!  The knowledge that fluoroquinolones are contraindicated in the pediatric population is as easy to access as a Wikipedia article, yet kids, innocent babies that are depending on us to protect them, are being given these drugs because their doctors are not heeding the warnings.  We MUST protect the children.  We must.  Because it’s really, really, really IMPORTANT.

In prescribing a fluoroquinolone in a situation that was not life threatening, and where other, safer drug alternatives were available, our doctors disregarded their Hippocratic Oath.  THE HIPPOCRATIC OATH IS IMPORTANT.  We need to scream at our doctors, nurses, pharmacists, etc. until they start following their Hippocratic Oath again.  It’s the moral basis of our medical system, or at least it should be, and it’s really, really important.

Another basis of our medical system that has been lost is INFORMED CONSENT.  It’s also quite important.  When drugs have dangerous, and sometimes permanent, side effects, as is the case with fluoroquinolones, it’s really, really important that informed consent be obtained before the drug is prescribed.  This rarely happens.  Patients are prescribed what they assume is a benign antibiotic.  They probably don’t even think about the side effects.  It’s an antibiotic, people take antibiotics all the time.  How could an antibiotic be harmful?  The sheet listing the side effects is included in the baggie when the prescription is filled, but the pharmacist doesn’t take the time to go over the side effects.  No one ever says, “This can damage your CENTRAL NERVOUS SYSTEM” or “This may permanently weaken all of the connective tissues in your body to the point where you become bed-ridden” or any number of warnings that can describe the horror of fluoroquinolone toxicity.  It is really important that a protocol be established when prescribing and filling prescriptions for fluoroquinolones.  All gatekeepers, at all steps in the process, should be informing patients of the possible consequences of taking these drugs.  To not obtain real informed consent is WRONG.

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It is important for side effects to be relevant.  It is important that doctors, nurses, pharmacists and especially patients know the RISKS associated with every drug.  Everyone involved in the system, including the patients, are guilty of disregarding warnings of side-effects.  Warnings are disregarded because they’re seen as arbitrary and unimportant.  They’re seen as arbitrary and unimportant because the FDA puts one-size-fits-all rules around what is said on drug packaging instead of adequately communicating REAL RISKS of each and every drug to doctors and patients alike.  If warnings are seen as arbitrary, if they’re not seen as real, they will not be heeded and people will get hurt.  It’s important that proper information be given to patients and that they know the risks associated with every drug that we put into our body.

The system let us down.  It’s important that we try to fix it so that it doesn’t let other people down.

Sometimes I wonder if fighting Bayer and Johnson & Johnson is possible.  I know that it is the right thing for me to do, but I get tired.  Fear takes over.  I wonder if I’m getting stuck in the past and stuck in a time in my life when I was sick, when I’m largely recovered, and that’s not a healthy thing to do.  Winning is borderline unimaginable.  Bayer and Johnson & Johnson are huge, powerful and have resources beyond my comprehension.  But then I think, who am I not to fight?  Not that many people see that there are some REALLY BIG PROBLEMS in the medical system, but I do, because of what I’ve been through, so I should take this (unwanted) gift of insight and use it – to scream.  Injustice is being done, people are being hurt and the system needs to be fixed.  So I will scream.  I will find a way to scream.  This blog is a start (maybe it’ll go viral – you never know (yes, that means share this post)), but bigger, better, louder ways of screaming are possible and I will do my best to find them.  BECAUSE BABIES ARE BEING POISONED.  Until they stop giving Cipro ear drops to 1-year-olds, I will scream – because it’s IMPORTANT to keep babies from being poisoned.  The fact that that needs to be said means that we live in a crazy world.  Let’s try to make it a little more sane.

 

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