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Fluoroquinolone Antibiotics Associated With Nervous System Damage

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The labels for fluoroquinolone antibiotics, Cipro, Levaquin, Avelox, etc. have two black box warnings, warnings reserved for only the most serious and severe adverse effects of drugs:

Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.

Fluoroquinolones may exacerbate muscle weakness with myasthenia gravis.  Avoid fluoroquinolones in patients with a known history of myasthenia gravis.

It is later noted that death can result from administration of fluoroquinolone antibiotics in people with myasthenia gravis, hence the warning that these drugs should be avoided in that population.

Central and Peripheral Nervous System Damage

In addition to the black box warnings, there is a 212 word warning of the adverse effects of these drugs on the central nervous system including, “dizziness, confusion, tremors, hallucinations, depression, and, rarely, psychotic reactions have progressed to suicidal ideations/thoughts and self-injurious behavior such as attempted or completed suicide” and seizures.

On August 15, 2013, the FDA announced that they were changing the warning labels for fluoroquinolones to more adequately describe the risk of permanent peripheral neuropathy.  The new warning labels will now note that peripheral neuropathy symptoms including “pain, burning, tingling, numbness, weakness, or a change in sensation to light touch, pain or temperature, or the sense of body position” can be caused by fluoroquinolones. They also note that peripheral neuropathy “can occur at any time during treatment with fluoroquinolones and can last for months to years after the drug is stopped or be permanent.”

Label Changes Based on Patient Reports

Also noted in the August 15th announcement was that the FDA was adding the warning of permanent peripheral neuropathy based on patient reports to their Adverse Event Reporting System (AERS) database. They note that, “the recent AERS review evaluated cases of fluoroquinolone-associated peripheral neuropathy with an outcome of ‘disability,’ reported between January 1, 2003 and August 1, 2012. The review showed a continued association between fluoroquinolones use and disabling peripheral neuropathy.”

Cipro was patented in 1983.  It took 30 years of people reporting their peripheral neuropathy to the FDA for them to add an appropriate warning to the label.

Additional Warning – Autonomic Nervous System Damage

Since the FDA is slow on the uptake of vital information that should be listed on the warning labels of drugs, I will let you know that, in addition to the central nervous system and the peripheral nervous system, the autonomic nervous system is also damaged by fluoroquinolone antibiotics. The autonomic nervous system, also known as the involuntary nervous system, is composed of the nerves that control heart rate, digestion, respiratory rate, salivation, perspiration, pupil dilation, urination and sexual arousal.  Damage to all of these body parts, controlled by the autonomic nervous system, are associated with fluoroquinolones.

How do I know this?  In addition to the patient led research and patient descriptions of autonomic system damage, I know this by personal experience. Every one of those autonomic functions was negatively affected when I had a severe adverse reaction to Cipro that began December of 2011.

Though we don’t yet have scientific proof, as no studies have been published, I have personally heard from hundreds of patients experiencing similar symptoms. Since it took 30 years for the FDA to recognize the peripheral neuropathy, I wouldn’t be too keen to disregard the possibility that the autonomic systems is also affected.

Why hasn’t the FDA investigated autonomic neuropathy potentially associated with the fluoroquinolones?  Perhaps because the malfunctions of the autonomic nervous system are very difficult to describe and detect and, though they are common among those who are suffering from Fluoroquinolone Toxicity Syndrome, they may not have risen to the top of the list of complaints in the AERS database.  However, seeing as damage to the autonomic nervous system is serious and potentially life-threatening, the FDA should connect the dots and add an additional warning of autonomic nervous system damage to fluoroquinolone labels.

Overall Nerve Damage

Since multiple nervous systems are damaged by fluoroquinolones, it leads me to believe that fluoroquinolones damage nerves generally.  Some early theories suggest that the fluoroquinolones induce the axons of nerves to degenerate and damage the myelin sheath protecting the nerves. Though I have several theories as to the damage mechanism for fluoroquinolones, anything conclusive other than reporting on what I experienced and have seen, is beyond my level of expertise. I do know that symptoms of nervous system damage are suffered from by the victims of fluoroquinolones and that they suffer mightily, sometimes permanently.

The possibility of fluoroquinolone toxicity is serious. With 26.9 million prescriptions for fluoroquinolone antibiotics dispensed in 2011 alone and the rate of fluoroquinolone induced peripheral neuropathy suspected at 1 per 6000, the number of potentially injured people is staggering. Worse yet, a 2011 study published in BioMed Central, found that 39% of fluoroquinolone therapy in hospital patients was unnecessary. Who knows what the rate of unnecessary fluoroquinolone use is in the general population.

Fluoroquinolones are dangerous antibiotics that are often used to treat sinus infections, urinary tract infections, upper respiratory infections, prostate infections, etc., infections that could be treated with a safer antibiotics. It is absurd and wrong for people to suffer from chronic and often debilitating nerve damage and other health conditions as a result of a prescription antibiotic, especially when other, safer alternatives can be used.

Information about Fluoroquinolone Toxicity

Information about the author, and adverse reactions to fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin) can be found on www.floxiehope.com.

We Need Your Help

More people than ever are reading Hormones Matter, a testament to the need for independent voices in health and medicine. We are not funded and accept limited advertising. Unlike many health sites, we don’t force you to purchase a subscription. We believe health information should be open to all. If you read Hormones Matter, like it, please help support it. Contribute now.

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This post was published previously on Hormones Matter in 2013.

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Repeated Use Doesn’t Make Fluoroquinolones Safe

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“I’ve prescribed fluoroquinolone antibiotics to hundreds of patients and I’ve never seen problems like yours. It’s a good drug with an excellent safety record.” 

Some version of that statement is said to many patients who approach doctors with the many symptoms of fluoroquinolone toxicity syndrome. Fluoroquinolones (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin) have been shown to damage connective tissue (tendons, ligaments, cartilage, fascia, etc.) throughout the body, damage the nervous systems (central, peripheral and autonomic), and lead to multi-symptom, often chronic, illness. Most of the symptoms of fluoroquinolone toxicity are listed on the 43 page warning label for cipro/ciprofloxacin.  However, disregard of patients with fluoroquinolone toxicity syndrome is, unfortunately, common. Statements like the one above are wrong-headed and foolish – here’s why:

  1. The statement of, “I’ve prescribed fluoroquinolone antibiotics to hundreds of patients and I’ve never seen problems like yours” and implying that therefore fluoroquinolones are safe, is an illogical argument based in ego, not fact.  Prescribing a drug hundreds of times does not make it a good, or safe, drug. The fact that something has been done millions times before does not mean that it’s the right way to do things. As an example, millions of people were given Vioxx before it was taken off the market because it causes heart attacks and strokes. If a physician never saw a heart attack result from Vioxx use, that doesn’t mean that they didn’t happen. They did. Thousands of people had heart attacks and died because of Vioxx. A history of doing something wrong does not make it right.  Implied in the statement that a physician has never seen fluoroquinolone damage is the assumption that what a physician sees is factual and without bias.  If a doctor regularly prescribes a drug, he or she is going to believe in its safety and efficacy based on a desire to see him or herself as one who helps patients, regardless of its actual safety and efficacy. Doctors have bias and ego just like the rest of us.  Anecdotal evidence, even anecdotal evidence from a doctor, is not able to trump experimental evidence.  Drugs need to hold up in scientific experiments and controlled trials – not in the opinion court of doctors.  In multiple experiments, fluoroquinolones have been shown to damage cells (by depleting mitochondrial DNA, magnesium, lipids, enzymes, etc.).  Science wins every time, and the scientific evidence comes down on the side of fluoroquinolones being dangerous drugs.
  2. It shows an unwillingness/inability to connect pharmaceutical drugs to multi-symptom diseases. Fluoroquinolones deplete mitochondrial DNA and lead to mitochondrial dysfunction. When mitochondria aren’t functioning properly, cells aren’t functioning properly. Mitochondria are the energy centers of eukaryotic cells – the engines. If cellular engines are malfunctioning, many systems shut down. This shut-down can lead to a cascade of damage – much of it self-perpetuating and difficult to repair. The details of the biochemistry behind this are incredibly complex and difficult, but the basic concept of drugs that cause mitochondrial damage lead to multi-symptom, chronic illness, isn’t so difficult that someone who went through med school shouldn’t be able to grasp it. But many doctors are loathe to admit that the drugs that they prescribe cause mitochondrial damage.  Many studies have shown that fluoroquinolones damage mitochondria (HERE and HERE). Even the FDA acknowledges that the mechanism through which fluoroquinolones do damage is through mitochondrial toxicity. Mitochondrial toxicity = multi-symptom, often chronic, illness. It’s not that hard. But if doctors admitted that fluoroquinolones cause multi-symptom, chronic illness, they may have to look at the relationship between all mitochondria damaging drugs (statins, SSRIs and even acetaminophen are on the list along with fluoroquinolones) and the rise in mysterious multi-symptom illnesses. If they did that, they may have to admit that the drugs they prescribed, ‘hundreds of times’ are hurting people – and who wants to do that?  It’s much easier to repeat the lie of, “these drugs have an excellent record of safety and efficacy,” than it is to admit to inflicting harm (even inadvertently) on patients.
  3. They’re not looking at delayed reactions or tolerance thresholds. Despite the fact that both delayed adverse reactions and tolerance thresholds for fluoroquinolones are documented (it all goes back to how mitochondria respond to damage – more HERE), reactions that occur after administration of the drug have stopped are not connected to the drug by many physicians. “It should be out of your system by now,” is repeated often.  That may be the case, but the drug set off an intracellular bomb and now the damage is self-perpetuating. Delayed reactions and tolerance thresholds may make recognition of adverse drug reactions difficult, but it doesn’t make them go away. Unfortunately, cells don’t always act as they “should” – they act as they do – with messy things like non-linear reactions, negative feedback loops, etc.
  4. The specialist model keeps many doctors from seeing the damage that fluoroquinolones cause. For example, ER doctors often prescribe fluoroquinolones because they’re powerful broad-spectrum antibiotics. But when people have an adverse reaction a week later that looks and feels a lot like an autoimmune disease, they’re not going to the ER for treatment because autoimmune-disease-like symptoms are for a rheumatologist or general practitioner to treat, not an ER doctor. This disconnect keeps many doctors from seeing the harm done by fluoroquinolones.
  5. Statements like, “I’ve prescribed fluoroquinolone antibiotics to hundreds of patients and I’ve never seen problems like yours. It’s a good drug with an excellent safety record.” communicate to patients that a physician’s anecdotal evidence is more important than a patient’s pain. It communicates that it’s okay for side-effects of a drug to be devastating as long as the doctor perceives the adverse reactions as rare. It’s not okay for a doctor to disobey his or her Hippocratic Oath and hurt patients – even inadvertently. And I would argue that adverse reactions to fluoroquinolones are far less rare than anyone would like to believe (arguments HERE and HERE).
  6. It shows that doctors don’t believe the warning labels on drugs. The warning label for Cipro/ ciprofloxacin is 43 PAGES long and lists many musculoskeletal and nervous system adverse effects of cipro and other fluoroquinolones. Do doctors think that the FDA is just kidding when they put all those adverse effects on the warning label?
  7. The mantra of, “fluoroquinolones have an excellent safety record” has been repeated so many times that it is assumed to be true. It is not true. There are hundreds of studies showing that fluoroquinolones profoundly damage cells and there are zero studies that show that people are immune to the damage caused by fluoroquinolones. The perception of safety is based on an unwillingness to recognize tolerance thresholds for fluoroquinolones, delayed adverse reactions to fluoroquinolones and the connection between fluoroquinolones and multi-symptom diseases.
  8. It shows that they’re afraid. Some of the fear is legitimate.  Antibiotic resistance is on the rise.  If fluoroquinolones are restricted to only being used appropriately – i.e. in life-or-death situations after all other antibiotics have failed – doctors will have fewer tools at their disposal and they may not be able to fight a nasty infection without inflicting cellular damage that results in chronic illness. No one wants to have to choose between an infection and multi-symptom, chronic illness.  It would be better to have neither. But if there aren’t any options of antibiotics that don’t cause the cellular damage that leads to oxidative stress and multi-symptom illness… well, that’s a possibility that is too frightening and daunting to think about.
  9. Too many doctors are attached to lazy medicine – throwing strong, broad-spectrum antibiotics at everyone who comes in the door with an infection (or just a high white blood cell count). If the adverse effects of fluoroquinolones were acknowledged, the pros and cons would have to be careful weighed before administering them.  A long discussion with patients about tendon ruptures, peripheral neuropathy, increased chance of diabetes, central nervous system damage, etc., would have to be had along with every prescription for Cipro, Levaquin or Avelox in order for an obligation of informed consent to be met. If broad-spectrum fluoroquinolones couldn’t be thrown at every infection, bacterial cultures would need to be done to figure out exactly what antibiotics would work best.  That takes time and money and it’s easier to do things as they have been done – even if it involves denying the damage that fluoroquinolones do.  Those pesky tests to make sure that the Hippocratic Oath is upheld may get in the way of business.

Adverse drug reactions don’t stop happening just because they’re inconvenient; or because they’re unrecognized or misdiagnosed. They don’t become rare or insignificant just because they are complicated and difficult to recognize.

Fluoroquinolones are dangerous drugs that damage cells on multiple levels. This has been shown in laboratories many times. The cellular damage caused by fluoroquinolones (along with the destruction of the microbiome) leads to multi-symptom, often chronic, illness. This has been shown by multiple patient reports.

Many doctors haven’t read the memo about how dangerous fluoroquinolones are though. Shouldn’t they know the dangers of the drugs that they prescribe?  Shouldn’t they have learned about adverse drug reactions in school?  It doesn’t seem like too much to ask for.  There are hundreds of studies showing that fluoroquinolones damage eukaryotic cells. Shouldn’t they have read them, or at least been told about them by the FDA?

You’d think so.  But the mantra of, “Fluoroquinolones have an excellent record of safety and efficacy” has been repeated so many times that it’s thought to be true just because it’s been heard over and over again.  Let’s change the mantra. How about, “fluoroquinolones are dangerous drugs that should only be used in life-or-death situations?” That mantra sounds much better.  It’s more appropriate, and it’s closer to the truth. If we keep on repeating it, maybe doctors will start to listen.

We Need Your Help

More people than ever are reading Hormones Matter, a testament to the need for independent voices in health and medicine. We are not funded and accept limited advertising. Unlike many health sites, we don’t force you to purchase a subscription. We believe health information should be open to all. If you read Hormones Matter, like it, please help support it. Contribute now.

Yes, I would like to support Hormones Matter. 

This post was first published on October 1, 2014.

Information about Fluoroquinolone Toxicity

Information about the author, and adverse reactions to fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin) can be found on Lisa Bloomquist’s site, www.floxiehope.com.

Photo by karatara: https://www.pexels.com/photo/male-statue-decor-931317/

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The Fluoroquinolone Time Bomb – Answers in the Mitochondria

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Two of the more perplexing features of Fluoroquinolone Toxicity (an adverse reaction to a fluoroquinolone antibiotic – Cipro/Ciprofloxacin, Levaquin/Levofloxacin, Avelox/Moxifloxacin or Floxin/Ofloxacin) are delayed reactions and tolerance thresholds. Both of these features of Fluoroquinolone Toxicity can be explained by noting that fluoroquinolones have been shown to damage mitochondria and cause oxidative stress, and that delayed onset of a disease state, as well as tolerance thresholds, are features of illnesses brought on by pharmaceutical induced mitochondrial damage and oxidative stress.

Delayed Reactions and Tolerance Thresholds with Fluoroquinolone Reactions

By “delayed reactions” I mean that adverse reactions to fluoroquinolones can occur weeks, months or even years after administration of the fluoroquinolone has stopped.  For the lawsuit filed by Public Citizen on behalf of patients who tore or ruptured tendons after taking a fluoroquinolone, (a suit that prompted the addition of the black box warning on all orally and IV administered fluoroquinolones) notes that “Fluoroquinolones, including CIPRO®, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants”. Tendon tears and ruptures that occurred within one year of the patient taking the fluoroquinolone were accepted as being related to the patient’s fluoroquinolone use. Patient reports have noted that new adverse symptoms of fluoroquinolone toxicity have occurred years after administration of the fluoroquinolone has ceased.

Many patients also experience a tolerance threshold for fluoroquinolone use.  A patient can tolerate fluoroquinolones well, experiencing few or no side-effects, until his or her threshold is reached.  After the patient’s tolerance threshold is reached, multisymptom systemic illness ensues. This patient’s story, found on the Fluoroquinolone Wall of Pain, illustrates the issue of tolerance thresholds:

On April 15, 2013 I was prescribed Avelox. I had been on this drug many times for chronic sinus infections. This time was different. Within 10 minutes of the first dose I went into anaphylaxis. I stopped breathing, had numerous convulsions and two grand Mal seizures. Since that day I have suffered with seizures, convulsions, tremors, debilitating fatigue, muscle weakness, vision loss, severe neuropathic pain, vomiting, nausea, lack of appetite, tendon, and vein problems.

This patient tolerated Avelox (moxifloxacin – a fluoroquinolone) well until her tolerance threshold was reached. Once her tolerance threshold was reached, she experienced multi-symptom systemic illness.

I personally experienced both a delayed reaction to Cipro/Ciprofloxacin (also a fluoroquinolone) and a tolerance threshold for it. I took 7 500-milligram pills of Cipro in 2009 without notable incident. I was even able to hike the entire 500-mile Colorado Trail in 2010 (no peripheral neuropathy or weakness were present at that time). When I took 7 more 500-milligram pills in 2011 I experienced a severe adverse reaction that began two full weeks after I was done taking the pills. I experienced multiple musculoskeletal (I couldn’t walk more than a block) and nervous system symptoms (I lost my memory and reading comprehension), and I would describe the reaction as feeling like a bomb had gone off in my body.

Fluoroquinolone Time Bomb: It’s All About the Mitochondria

My experience of a delayed onset of systemic health issues after having previously tolerated Cipro/Ciprofloxacin well, is typical of diseases that are brought on by a pharmaceutical causing mitochondrial dysfunction. (Multiple journal articles have noted that fluoroquinolones cause mitochondrial damage and oxidative stress.)

In “Mechanisms of Pathogenesis in Drug Hepatotoxicity Putting the Stress on Mitochondria” it is noted that:

…damage to mitochondria often reflects successive chemical insults, such that no immediate cause for functional changes or pathological alterations can be established. There is indeed experimental evidence that prolonged injury to mitochondria, such as that which typifies oxidative injury to mitochondrial DNA or to components of the electron transport chain (ETC), has to cross a certain threshold (or a number of thresholds) before cell damage or cell death becomes manifest.

Each time mitochondria is injured, the patient gets closer to his or her personal tolerance threshold for mitochondrial damage. Once the threshold is crossed, cell damage and apoptosis occur – which manifest themselves in various states of illness.

It is further explained in “Mechanisms of Pathogenesis” that:

…approximately 60% of mitochondrial DNA must be deleted from the mouse genome before complex IV activity is compromised and serum levels of lactate are elevated. This non-linear response can be explained upon consideration that the molecules that subserve mitochondrial function (e.g., mitochondrial DNA, mRNA, and ETC proteins) are present in excess of amounts required for normal cell function. This reserve (or buffering) capacity acts as a protective mechanism; however, at a certain stage of damage, the supply of biomolecules needed to support wild-type mitochondrial function becomes compromised.

The lay person’s summary of the above excerpts is that we have excess mitochondrial DNA and that excess mitochondrial DNA keeps each of us from developing a systemic multi-symptom illness whenever mitochondrial DNA is adversely affected (many pharmaceuticals and environmental toxins adversely affect mitochondrial DNA). However, when mitochondrial DNA is depleted sufficiently, cellular dysfunction, oxidative stress and cell death, ensue.

Multiple studies have noted that fluoroquinolones deplete mitochondrial DNA (here, here and here).  When enough mitochondrial DNA are depleted, adverse reactions that are systemic and include multiple symptoms simultaneously, occur.

Multi-Symptom Reaction: Look to Mitochondrial Damage

It is often difficult for the patient who is experiencing a systemic multi-symptom illness to connect his or her illness to the mitochondria damaging drug or toxin that hurt him or her because of the time delay between the cause (mitochondria damaging chemical) and the effect (bomb going off in body and mind). Though the delayed onset of fluoroquinolone toxicity and mitochondrial dysfunction symptoms are noted in many articles (here, here), the reason for the delayed onset of symptoms is not known.  In “Mechanisms of Pathogenesis” it is hypothesized that “an initial adaptive response was followed by a toxic response” when cells are exposed to a mitochondria damaging chemical. Perhaps the delay in adverse reaction onset is due to a toxic response taking time to develop.

Many pharmaceuticals damage mitochondria. Bactericidal antibiotics (including fluoroquinolones), Statins, acetaminophen, some chemotherapy drugs, vaccines, and many others, cause mitochondrial dysfunction, oxidative stress and cell death. Mitochondrial dysfunction and oxidative stress are connected to a variety of ailments, from chronic fatigue syndrome to Alzheimer’s disease and obesity. However, the FDA and other drug regulatory agencies have systematically ignored damage to mitochondria caused by pharmaceuticals and “mitochondrial toxicity testing is not required by the US FDA for drug approval.”

The recognition of delayed adverse reactions and tolerance thresholds for mitochondrial damaging drugs and vaccines will go far in helping both doctors and patients to recognize mitochondrial damage related adverse drug reactions (and adverse vaccine reactions). Once the reactions are recognized, perhaps some pressure can be put on the FDA and/or the pharmaceutical companies to test how drugs affect mitochondria before they are released onto the market. After all, mitochondrial damage and oxidative stress are causally related to almost every chronic illness.  It would be nice if doctors, those in the pharmaceutical industry, the FDA regulators, and others, recognized the harm that drugs do to mitochondria, and the symptoms of iatrogenic mitochondrial dysfunction.

Information about Fluoroquinolone Toxicity

Information about the author, and adverse reactions to fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin) can be found on Lisa Bloomquist’s site, www.floxiehope.com.

Share Your Story

If you have suffered from a fluoroquinolone or any other medication reaction, please consider sharing it on Hormones Matter.

We Need Your Help

More people than ever are reading Hormones Matter, a testament to the need for independent voices in health and medicine. We are not funded and accept limited advertising. Unlike many health sites, we don’t force you to purchase a subscription. We believe health information should be open to all. If you read Hormones Matter, like it, please help support it. Contribute now.

Yes, I would like to support Hormones Matter.

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This story was published originally on Hormones Matter in March 2014.

 

 

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Friends Don’t Let Friends Take Fluoroquinolones: Four Stories

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I’ve been writing about the dangers of fluoroquinolone antibiotics (cipro/ciprofloxacin, levaquin/levofloxacin, avelox/moxifloxacin, floxin/ofloxacin and a few others) for a little over a year. As my friends, family, and associates have read what I’ve written, their skepticism has waned and many of them have realized that I actually know what I’m talking about when I say that fluoroquinolones are dangerous drugs that lead to destruction of connective tissues and nerves throughout the body. They have glanced at my source articles and noted that there are peer-reviewed journal articles that back up what I say.  It feels nice to be believed. It feels even nicer when those people let me know that they didn’t take fluoroquinolones because of the information that I gave them. It’s nice to know that they won’t get “floxed.”

In the last few months, several friends have approached me, asking about alternatives to fluoroquinolones. Here are some of their stories. All their names have been changed, but the stories are true.

Rick and the Sinus Infection

Rick was prescribed Levaquin to treat a sinus infection. He read through the warning label and noted that two of the listed side-effects are tendon ruptures and seizures. Rick has a seizure disorder and had surgery on a tendon in his foot six months earlier. He refused the Levaquin prescription and asked for something else. He was prescribed Bactrim. The Bactrim cleared up his sinus infection.

Question – What was that doctor thinking? Why would a doctor prescribe a drug that is well-documented as causing destruction of tendons to a patient who has a history of tendon problems?  Rick told the doctor that he had surgery on his tendon in his foot. Did the doctor think that the tendon issues that are severe enough to lead to a black box warning on all fluoroquinolones was something to be dismissed and disregarded?  And why would a doctor prescribe a drug that can cause seizures, along with a myriad of other central nervous system problems, to a person who has a pre-existing seizure disorder?  It seems like a negligent decision – or at least a horribly uninformed decision.  Unfortunately, the disregard of well established side-effects happens all the time. The contraindications for fluoroquinolones are routinely ignored and patients with pre-existing conditions are frequently prescribed fluoroquinolones for non-serious infections where other antibiotics would be sufficient. If Rick hadn’t read the warning label himself, and insisted on being prescribed a more benign antibiotic, he might have become one of the millions suffering from and adverse reaction to fluoroquinolones.

Melissa and the Use of Cipro in Children

Melissa’s 2-year old daughter suffered from ear infections. She was prescribed Cipro twice to treat the ear infections. Both times, Melissa refused the prescription for Cipro and was given something else.  A more benign antibiotic, then tubes put in her daughter’s ears, cleared up the infections.

Again, what was the doctor thinking? Fluoroquinolones are contraindicated in the pediatric population because they have been shown to damage the cartilage and joints of juvenile animals (source).  A review in U.S. Pharmacist noted that:

“Fluoroquinolones have demonstrated adverse effects on cartilage development in juvenile animals through the inflammation and destruction of weight-bearing joints.  These arthropathies were often irreversible, and their potential occurrence in children limited the use of fluoroquinolones in this population. In one pediatric study, ciprofloxacin had a 3.3% (9.3% vs. 6.0%) absolute risk increase in musculoskeletal events within 6 weeks of treatment compared with control agents used to treat complicated UTIs or pyelonephritis. Adefurin and colleagues found a 57% increased relative risk of arthropathy in children given ciprofloxacin (21% overall) versus those in a non-fluoroquinolone comparator arm. In contrast to animal models, neither dose nor duration had an effect on the rate or severity of arthropathy.  A 2007 study by Noel and colleagues determined the incidence of musculoskeletal events (primarily arthralgias) to be greater in children treated with levofloxacin compared with nonfluoroquinolone-treated children at 2 months (2.1% vs. 0.9%; P = .04) and 12 months (3.4% vs. 1.8%; P = .03).  These results and the severity of the effects should be weighed heavily when initiation of fluoroquinolones is being contemplated in pediatric patients.” (source)

Fluoroquinolones can cause irreversible damage to the cartilage of juvenile animals, and adult humans, so did Melissa’s daughter’s doctor think that somehow toddlers with ear infections were exempt from being damaged by Cipro? Melissa’s daughter could have been hurt. She could have been damaged by the Cipro. She could have developed permanently weakened tendons, lesions on her cartilage, destruction of her joints, etc. None of the damaging effects of fluoroquinolones are easy to treat, and their severe side-effects should not be the trade off when treating pediatric ear infections.

Did that pediatrician completely forget his or her Hippocratic Oath?  She must have, because Cipro could have done severe, irreversible, life-long harm to the toddler.

Fluoroquinolones during Pregnancy? Denise’s Story

Denise was eight months pregnant when she came down with an upper respiratory infection. Her doctor tried to prescribe her Cipro. She refused the Cipro and instead took Azithromycin.

Azithromycin just happens to be the only antibiotic ever studied in pregnant women, at least partially. That is, there is one study showing basic pharmacokinetic or dosing information for its use during pregnancy. There are no data on the health and well-being of the offspring.

Given the total lack of data for medication use during pregnancy, one has to wonder what that doctor was thinking prescribing Cipro, one of the most potent and dangerous antibiotics, to a pregnant woman.  Why in the world would he prescribe a fluoroquinolone to a pregnant woman?  In big, bold, capitalized words on the Cipro warning label, it is stated that, “THE SAFETY AND EFFECTIVENESS OF CIPROFLOXACIN IN PREGNANT AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED.”  The warning label goes on to note that, “No differences in the rates of prematurity, spontaneous abortions, or birth weight were seen in women exposed to ciprofloxacin during pregnancy. However, these small post-marketing epidemiology studies, of which most experience is from short-term, first trimester exposure, are insufficient to evaluate the risk for less common defects or to permit reliable and definitive conclusions regarding the safety of ciprofloxacin in pregnant women and their developing fetuses.”  Note that no research has ever been done to investigate the effects of fluorquinolones on fetal development and child development post pregnancy when used during the second or third trimesters.

Differences in musculoskeletal development, cognitive development, mitochondrial and microbiome health, etc. of the children of women given Cipro while pregnant weren’t looked at in the first trimester studies that were done. Those are the things that should be examined – not just spontaneous abortions and low birth weights. Indeed, these effects should be looked into for all meds prescribed during pregnancy, as very few medications routinely prescribed to pregnant women have ever been tested. Most physicians know this, or should know this, but over the last few decades, have ignored it and prescription medication use during pregnancy has increased by 60%. Concurrently, the rates of chronic childhood disorders from autism and neurodevelopmental disorders, to obesity and Type 2 diabetes have increased significantly.  Perhaps before we so cavalierly prescribe medications to pregnant women, we ought to investigate the long-term effects on their children.

Violet and Cipro for Traveler’s Diarrhea?

Violet was planning a trip to Ecuador. Her travel doctor wanted to give her Cipro just in case she got traveler’s diarrhea. Many other, less problematic antibiotics are available and equally effective in treatment of traveler’s diarrhea – doxycycline, Bactrim or sepra.  She asked for a prescription for something other than Cipro.  

The appropriate situation for fluoroquinolones to be used is when they are needed to save a life and when a life-threatening infection doesn’t respond to other antibiotics. To prescribe fluoroquinolones in situations where life-threatening infections are not present is absurd and it is wrong. To prescribe fluoroquinolones prophylactically, when no infection is present, for treatment of traveler’s diarrhea, is to completely disregard all of the dangers of fluoroquinolones that are listed on the 43 PAGE warning label (for Cipro – the ones for levaquin, avelox and floxin are equally as bad).  The adverse effects for the fluoroquinolones include: permanent peripheral neuropathy, tendon ruptures, Stevens-Johnson syndrome, hepatic failure, hallucinations, suicidal ideation, and more.

Fluoroquinolones should not be prescribed frivolously. They should not be prescribed to anyone who is not in a life-threatening situation. The risk for adverse effects of these drugs are such that their use is not appropriate in situations that are not life-threatening and they certainly should not be used prophylactically for traveler’s diarrhea.

To all the doctors who prescribe Cipro and other fluoroquinolones prophylactically to people for traveler’s diarrhea – What are you thinking? There is nothing that is okay about giving a drug to a healthy person that can injure them grievously. Even if the chances are low (but no one really knows the incidence of fluoroquinolone toxicity), the severity of the adverse effects of fluoroquinolones are so extreme that fluoroquinolones shouldn’t even be considered as a treatment until other antibiotics have been tried, and have failed.

To all the doctors whose knowledge of the drugs that they prescribe I have questioned – please, please, please read some of the articles about how dangerous fluoroquinolones are. I have more than 100 peer reviewed articles listed HERE.  Or, just read the warning labels and note that all of the horrible symptoms listed on the warning label can happen to your patients at once. You don’t want to do that to your patients.  Please DON’T do that to your patients. Prescribe more benign antibiotics. They’re available. Use them first.  Please.

Information about Fluoroquinolone Toxicity

Information about the author, and adverse reactions to fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin) can be found on Lisa Bloomquist’s site, www.floxiehope.com.

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Image credit: Lisa Bloomquist.

This article was published originally on Hormones Matter on June 30, 2014.

 

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Fluoroquinolones 101 – Antibiotics to Avoid

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Fluoroquinolone antibiotics, Cipro, Levaquin, Avelox, etc. are broad-spectrum antibiotics used to treat a variety of infections, from urinary tract infections to anthrax and everything in between.  The first quinolone created was Nalidixic Acid which was discovered by George Lesher in 1962.  (Nalidixic Acid was added to the OEHHA prop 65 list of carcinogens in 1998.) Cipro (ciprofloxacin) is a second generation fluoroquinolone patented in 1983 by Bayer, Levaquin (levofloxacin) is a third generation fluroquinolone  patented in 1987 by Ortho-McNeil-Janssen (a division of Johnson & Johnson), and Avelox (moxifloxacin) is a fourth generation fluoroquinolone patented in 1991 by Bayer.

Fluoroquinolone Antibiotics – Still on the Market

Of the 30 quinolones that have made it to market since the 1980s, all but 6 have either been removed from the US market or have severely restricted use.

The fluoroquinolone antibiotics that are still on the market are some of the most commonly prescribed antibiotics. Per the FDA, “Approximately 23.1 million unique patients received a dispensed prescription for an oral fluoroquinolone product from outpatient retail pharmacies during 2011,” and “Within the hospital setting, there were approximately 3.8 million unique patients billed for an injectable fluoroquinolone product during 2011.”

When used properly, such as in cases of life-threatening hospital acquired pneumonia, fluroquinolone antibiotics can save lives.

Fluoroquinolone Antibiotic Side-Effects and Adverse Reactions

When used improperly, fluoroquinolone antibiotics can needlessly cause devastating side-effects.  Devastating side-effects can also occur when fluoroquinolone antibiotics are used properly, but the devastation can be justified by weighing it against the alternative – death.  In 2001, Dr. Jay S. Cohen published an article on the severe and often disabling reactions some people sustained  as a result of taking a fluoroquinolone antibiotic.  Dr. Cohen says,

“It is difficult to describe the severity of these reactions. They are devastating. Many of the people in my study were healthy before their reactions. Some were high intensity athletes. Suddenly they were disabled, in terrible pain, unable to work, walk, or sleep.”

Dr. Cohen’s study of 45 subjects suffering from Fluoroquinolone Toxicity Syndrome, a name that I’m pushing for, (without an official name, it is difficult get the word out) showed that they had the following symptoms:

  • Peripheral Nervous System: Tingling, numbness, prickling, burning pain, pins/needles sensation, electrical or shooting pain, skin crawling, sensation, hyperesthesia, hypoesthesia, allodynia (sensitivity to touch) numbness, weakness, twitching, tremors, spasms.
  • Central Nervous System: Dizziness, malaise, weakness, impaired coordination, nightmares, insomnia, headaches, agitation, anxiety, panic attacks, disorientation, impaired concentration or memory, confusion, depersonalization, hallucinations, psychoses.
  • Musculoskeletal: Muscle pain, weakness, soreness, joint swelling, pain, tendon pain, ruptures.
  • Special Senses: Diminished or altered visual, olfactory, auditory functioning, tinnitus (ringing in the ears).
  • Cardiovascular: Tachycardia, shortness of breath, hypertension, palpitations, chest pain.
  • Skin: Rash, swelling, hair loss, sweating, intolerance to heat and\or cold.
  • Gastrointestinal: Nausea, vomiting, diarrhea, abdominal pain.

When a fluoroquinolone antibiotic triggers a toxic reaction in a person, multiple symptoms are often experienced. I experienced all of the symptoms that are italicized.

Fluoroquinolone Antibiotic Damage – Technical Aspects

Fluoroquinolones are eukaryotic DNA gyrase and topoisomerase inhibitors very similar to many antineoplastic agents (source).  What this means in plain English is that these drugs work the same way as chemotherapeutic drugs; they disrupt DNA and lead to destruction of cells.  A recent (2013) study conducted by a team of scientists at the Wyss Institute for Biologically Inspired Engineering at Harvard University Studies showed that Ciprofloxacin, along with a couple of other non-fluoroquinolone antibiotics, causes oxidative stress and mitochondrial malfunction. A 2011 study published in the Journal of Young Pharmacists found that, “There is significant and gradual elevation of lipid peroxide levels in patients on ciprofloxacin and levofloxacin.”  They also found that “There was substantial depletion in both SOD (superoxide dismutase, “a free radical scavenging enzyme”) and glutathione levels” and that “On the 5th day of treatment, plasma antioxidant status decreased by 77.6%, 50.5% (and) 7.56% for ciprofloxacin, levofloxacin and gatifloxacin respectively.” The study also notes that administration of fluoroquinolones leads to a marked increase in the formation of Reactive Oxygen Species (ROS) and that “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.”

How Many People are at Risk?

The exact rate of adverse reactions to fluoroquinolones is difficult to determine.  Studies of adverse reactions to fluoroquinolones have noted that, “During clinical trials, the overall frequencies of adverse effects associated with (fluoroquinolones) to vary between 4.4 and 20%.”  Just the fact that the spread is so large, a 15.6% spread in frequency of adverse reactions is a HUGE difference, implies that the actual occurrence of adverse reactions is difficult to establish or unknown.

With the FDA figures above noting that 26.9 million unique patients were given fluoroquinolones in 2011, if you just take the conservative adverse reaction figure of 4.4%, you’ll get a horrifying number of people with adverse reactions in 2011 alone – 1,183,600 people.  20% of 26.9 million is 5,380,000 people adversely effected.  That is scary.  Those numbers are truly frightening given the severity of the adverse effects described above.

Fluoroquinolone Toxicity Syndrome

I see fluoroquinolone toxicity everywhere, and even I think that those numbers are high for severe, disabling reactions like mine where multiple symptoms develop simultaneously.  Not everyone who has an adverse reaction to a fluoroquinolone has a reaction like mine, or even develops Fluoroquinolone Toxicity Syndrome – thank God.  Many people have milder reactions.  Milder symptoms include any one of the symptoms listed above as well as  diarrhea, vomiting, mild tendonitis, decreased energy, painless muscle twitches, memory loss, urgency of urination, or any number of reactions that the body may have to a massive depletion of antioxidants and increases in lipid peroxide levels and reactive oxygen species production.

Even though severe adverse reactions to fluoroquinolones antibiotics can be painful and disabling for years, many (possibly most, but certainly not all) people recover from Fluoroquinolone Toxicity Syndrome with time.  I anticipate that I will be fully recovered 2 years after my reaction started. Sadly, there are some people who don’t recover.  They suffer from chronic pain, disability, impaired cognitive abilities, etc. permanently.

It is absurd, to say the least, that an acute problem, an infection, that can easily be taken care of with administration of an antibiotic that is not a fluoroquinolone, is converted into a chronic problem, a  syndrome that can disable a person for years, by a prescription ANTIBIOTIC, used as prescribed. In my case, a urinary tract infection that could have likely been taken care of with macrobid or even cranberry juice and d-mannos, was treated with Cipro which left me unable to do many physical and mental tasks that I had previously been able to do with ease. It’s a crazy, absurd situation.  It’s absurd and it’s wrong.

Some Antibiotics are More Dangerous than Others

The bottom line is that these popularly prescribed antibiotics are dangerous drugs that have caused thousands of people to suffer with a myriad of maladies. Undeniably, they have their place, in treating life-threatening infections.  Unfortunately, they are not being reserved for use in life-threatening situations and people are being hurt after taking them for simple sinus, urinary tract, bronchial and prostate infections. A strict and rigorous protocol needs to be established to limit the damage that they cause; because it’s not right to maim and disable people to treat their sinus infections.

Information about Fluoroquinolone Toxicity

Information about the author, and adverse reactions to fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin) can be found on Lisa Bloomquist’s site, www.floxiehope.com.

This article was published previously in August 2013 and is being re-posted in light of the recent press coverage warning of fluoroquinolone dangers.

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Shades of Grey – The Good and Bad of Fluoroquinolones

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Lisa Bloomquist flouroquinolone antibiotics

A friend of mine recently commented on one of my posts about fluoroquinolone toxicity, “I totally appreciate these articles and my heart goes out to those suffering, but are there people who have benefited from these antibiotics? I’m not trying to stir the pot, I’m curious as I would think many readers would be.”

I really appreciate the inquiry, and I’m sure he’s right in thinking that many people have the same question. Here is my response:

Yes – absolutely – lives have been saved by fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin). They are powerful, broad-spectrum antibiotics and, as such, they have saved the lives of people who are suffering from severe, life-threatening infections.

Unfortunately, fluoroquinolones come with severe side-effects that include cellular damage. They have been shown to deplete mitochondrial DNA and induce large amounts of oxidative stress (also known as reactive oxygen species or ROS). Both mitochondrial damage and oxidative stress have been linked to many chronic, multi-symptom diseases, including chronic fatigue syndrome / M.E., Alzheimer’s, diabetes, Parkinson’s, fibromyalgia, autism, Gulf War Syndrome, and many others. Fluoroquinolone toxicity syndrome is a multi-symptom, chronic illness that is often misdiagnosed as fibromyalgia, CFS/ME, an autoimmune disease, etc. Fluoroquinolones have been shown to cause destruction of tendons, cartilage and muscles, as well as permanent peripheral neuropathy and severe central nervous system reactions.

Fluoroquinolones are being used Inappropriately

Because of the severity of the side-effects of fluoroquinolones, it is inappropriate for them to be used when other, more benign, antibiotics will effectively fight an infection. They are only appropriate for use in situations where more benign antibiotics have failed, and a person’s life is threatened by an infection.

Unfortunately, many people are given Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin or Floxin/ofloxacin for sinus infections, urinary tract infections, respiratory infections, and prostate infections. Fluoroquinolones are even prescribed when no infection is present for suspected infections (they are often prescribed prophylactically for travelers’ diarrhea).

Think of Fluoroquinolones as Chemo Drugs – They Are

Fluoroquinolone antibiotics should be thought of as anti-cancer chemo drugs. In fact, they have been investigated for their cancer-fighting / tumor killing properties. Chemo drugs can save lives – there is no doubt about that. But, because of the harm that the drugs themselves do, it is not appropriate to give them to people unless they have cancer or are in a life-or-death situation. Similarly, it’s not appropriate to give people fluoroquinolones for simple infections that could be treated with more benign antibiotics.

The Hippocratic Oath and Informed Consent – Forgotten Bedrocks of Medicine

Despite the fact that fluoroquinolones have severe side-effects, very few people are advocating for their removal from the market. When they are needed to save a life, they should be available. What most people (myself included) are advocating for is sensible, appropriate use of fluoroquinolones. Neither Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin nor Floxin/ofloxacin should be prescribed to people who can be helped by a more benign antibiotic. (Adherence to the Hippocratic Oath should prevent this from happening, but it’s not). Fluoroquinolones should not be given to people without a warning about the severe cellular damage that can be done by these drugs. (Informed consent is important.) In order for fluoroquinolones to be thought of and administered appropriately, both physicians and patients need to be aware of how dangerous fluoroquinolones are, and how severe their adverse effects can be.

Through people telling their stories of how fluoroquinolones hurt them, awareness of the dangers of fluoroquinolones will come. Hopefully, sensible and appropriate use of these powerful, dangerous drugs will follow.

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.

Information about Fluoroquinolone Toxicity

Information about the author, and adverse reactions to fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin) can be found on Lisa Bloomquist’s site, www.floxiehope.com.

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Patient stories are important. Help spread awareness. Write for us.

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Hormones MatterTM is conducting research on the side effects and adverse events associated with the fluoroquinolone antibiotics, Cipro, Levaquin, Avelox and others: The Fluoroquinolone Antibiotics Side Effects Study. The study is anonymous, takes 20-30 minutes to complete and is open to anyone who has used a fluoroquinolone antibiotic. Please complete the study and help us understand the scope of fluoroquinolone reactions.

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