antibiotic dangers

Victory at the FDA for Fluoroquinolone Victims

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FDA Meeting Fluoroquinolones

In the four years since I was hurt by ciprofloxacin, a fluoroquinolone antibiotic, I have often fantasized about what I would say to the FDA if I had chance. Would I tell them about the pain and suffering I experienced after taking ciprofloxacin? Would I tell them stories about my friends who have had their lives wrecked by fluoroquinolone toxicity? Would I share with them the knowledge that I have gained from obsessively researching fluoroquinolone toxicity? Would I berate them and yell, “Do your ^%^& job?” Would I beg them to, at the very least, keep these dangerous drugs away from children?

On November 5, 2015, I had the opportunity to testify before the FDA’s Antimicrobial Drugs Advisory Committee in a meeting specifically to address the risks of fluoroquinolone antibiotics (Cipro, Levaquin, Avelox, Floxin, and their generic equivalents). I, along with thirty-five other people, testified, and I chose to note the damage that ciprofloxacin did to me and to point out some of the mechanisms through which fluoroquinolones hurt people. Others gave poignant and heart-breaking testimonies about the loss of their health, or the loss of their loved ones, and a few doctors and consumer advocates testified as well. You can read some of the presentations that were provided to the FDA committee in THIS POST.

I am happy to report that the meeting resulted in an overwhelming victory for victims of fluoroquinolone antibiotics. The committee ruled that the current warning labels do NOT appropriately address the risks associated with fluoroquinolones for treatment of sinusitis, bronchitis in those with COPD, or uncomplicated urinary tract infections.

This is a HUGE step in the right direction, and it is my sincere hope that it will result in the FDA dramatically cutting the number of unnecessary fluoroquinolone prescriptions, and better treatment for those who are suffering from adverse reactions to fluoroquinolones.

Acknowledgement of Disability Caused by Fluoroquinolones

Additionally, in the meeting brief, the FDA identified a syndrome associated with fluoroquinolone toxicity—one that “floxies” have been pushing for recognition of for years. It is called Fluoroquinolone Associated Disability (FQAD). According to the FDA:

“While most of the individual AEs (adverse events) that exist within FQAD (fluoroquinolone associated disability) are currently described in fluoroquinolone labeling, the particular constellation of symptoms across organ systems is not. Individuals with FQAD were defined as U.S. patients who were reported to be previously healthy and prescribed an oral fluoroquinolone antibacterial drug for the treatment of uncomplicated sinusitis, bronchitis, or urinary tract infection (UTI). To qualify, individuals had to have AEs reported in two or more of the following body systems: peripheral nervous system, neuropsychiatric, musculoskeletal, senses, cardiovascular and skin. These body systems were chosen as they had been observed to be frequently involved with the fluoroquinolone reports describing disability. In addition, the AEs had to have been reported to last 30 days or longer after stopping the fluoroquinolone, and had to have a reported outcome of disability.”

That acknowledgement from a FDA committee, that fluoroquinolones cause a disabling constellation of symptoms in previously healthy individuals, is a HUGE victory for victims of fluoroquinolones.

Next Steps in the Fluoroquinolone Toxicity Battle

Next, the committee will make recommendations to the FDA. Presumably they will recommend that the FDA update the warning labels to note that the constellation of symptoms associated with FQAD, so as to educate physicians and patients of the risks of this class of antibiotics.

The FDA may enact other means of more properly addressing the risks associated with fluoroquinolone use, such as enrolling fluoroquinolones in the Risk Evaluation and Mitigation Strategies (REMS) program.

Several FDA committee members mentioned the need for further studies of fluoroquinolones, and hopefully some long-term and intergenerational studies will be conducted.

I hope that the FDA does all of these things, and that fluoroquinolone use is curtailed significantly. More than 23 million prescriptions for fluoroquinolones were dispensed in the U.S. in 2011 alone, and as many as 90% of those prescriptions were inappropriate given the true risk profile of fluoroquinolones.

We shall see if the FDA does anything with the information that was presented to the committee, and what they do with the committee’s recommendations.

Thoughts on Advocacy Efforts Directed at the FDA

Other groups of patient advocates who are interested in replicating the success of “floxies” in getting a favorable ruling from a FDA committee may be wondering what caused the FDA to look at fluoroquinolones. I believe that the FDA’s decision to hold the committee meeting was a culmination of several factors.

First, people have been reporting disabling reactions to fluoroquinolones to the FDA using their adverse event reporting system (FAERS). I encourage everyone who has experienced an adverse reaction to a drug or medical device to file a report with FAERS.

Second, more than 150 news stories about the dangers of fluoroquinolones have aired in the last two years. You can view them through THIS LINK. The news stories were prompted by the persistence of victims of fluoroquinolones reaching out to their local news stations.

Third, two citizens’ petitions have been filed with the FDA. One notes that serious psychiatric adverse effects can be the result of fluoroquinolone use. Another petition notes that mitochondrial toxicity should be added to the warning labels for fluoroquinolones.

Fourth, concerned citizens met with the FDA to discuss the dangers of this class of drugs.

Basically, people have been screaming at the FDA through multiple venues demanding that they hear us. At the committee meeting, they heard us.

I encourage everyone who has been hurt by a drug or medical device to report their story to the FDA, to tell their story loudly and persistently through the media, and to organize social media groups so that your message is spread far and wide, and heard loud and clear.

“Floxies” have come a long way in getting the dangers of fluoroquinolones recognized by the FDA, but we still have a long way to go. As nice as acknowledgement and being heard are, action is needed to get what we really want—change in how fluoroquinolones are viewed and prescribed. We are moving in the right direction. One step at a time, and we will reach our goals of prudent and appropriate use of fluoroquinolones, as well as healing for those adversely affected by these drugs.

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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Fluoroquinolone Antibiotic Dangers: Why Didn’t They Tell Me?

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Lisa Bloomquist

Hundreds of articles about the harmful effects of fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin) have been published in medical and scientific journals, yet most of the articles have been ignored by the medical community and downplayed by the FDA. I can only surmise that the ignorance around the dangers of fluoroquinolones is because they are used as antibiotics and antibiotics are “supposed” to be safe and only damage bacteria, while leaving human cells unscathed. Or maybe it is because of the constant repetition of the baseless statement that fluoroquinolones have an “excellent record of safety and tolerance;” a statement that is only true if delayed reactions, tolerance thresholds and epigenetic effects are not taken into consideration.

Regardless of the motivations of those who are ignoring how destructive fluoroquinolones are, valuable information about the safety (or rather, the dangers) of fluoroquinolones as a class of drugs, have been ignored. Warnings about the toxicity of fluoroquinolones have been noted in journal article after journal article, yet they are still some of the most popular antibiotics prescribed.

Caution, prudence and thoughtfulness should be exercised when prescribing drugs that are as dangerous and destructive as fluoroquinolones. Fluoroquinolones are chemo drugs that are being mis-prescribed as antibiotics. Before filling a prescription for a fluoroquinolone to treat a sinus infection, or to use prophylactically for traveler’s diarrhea, or putting in your child’s ear to treat an ear infection, I encourage you to note the cellular destruction done by fluoroquinolones. Neither the FDA nor the average doctor is properly warning patients about the dangers of fluoroquinolones. Unfortunately, it is up to patients to inform themselves and gain proper warnings about the consequences of these dangerous drugs.

Fluoroquinolones Damage DNA

Back in 1992, when fluoroquinolones were first gaining popularity, Scientists raised concerns about their safety in an article published by the Proceedings of the National Academy of Sciences of the United States:

“the interaction (of fluoroquinolones) with DNA is still of great concern because of the possible long-term genotoxicity of quinolone compounds, which are increasingly adopted as first-choice antibiotics for the treatment of many infections, and because it addresses the real mechanism of action of this class of molecules.”

Fluoroquinolones are topoisomerase interrupters, meaning that their mechanism of action is described as, “The bactericidal action of ciprofloxacin results from 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.” (Cipro warning label).

Very little, if any, concern over the possible genotoxic effects of fluoroquinolones were expressed to the public as they gained popularity and uses were expanded in the early 1990s. The warnings and concerns expressed by the scientists quoted were ignored.

It is noted in Molecular Pharmacology, “Delayed Cytotocicity and Cleavage of Mitochondrial DNA in Ciprofloxacin Treated Mammalian Cells” that fluoroquinolones “cause a selective loss of mitochondrial DNA (mtDNA)” and “The loss in mtDNA was associated with a delayed loss in mitochondrial function.” Additionally, it is stated that “ciprofloxacin induces reversible double-stranded breaks in nuclear DNA.” Studies have shown that both mitochondrial and nuclear DNA is adversely affected by fluoroquinolones, yet those studies have not gained traction in the medical community and have effectively been ignored.

The intergenerational effects of depleting DNA with fluoroquinolones is unknown at this time (I surmise that this is because these studies have been ignored, intergenerational studies are difficult to do, and funding for them is hard to come by). However, it is known that, “a number of human mitochondrial genetic diseases that are clinically discreet are being diagnosed at unexpected rates” (source). Additionally, in an article published in Nature in 2013 entitled, “Topoisomerases facilitate transcription of long genes linked to autism” it was noted that, “Our data suggest that chemicals or genetic mutations that impair topoisomerases, and possibly other components of the transcription elongation machinery that interface with topoisomerases, have the potential to profoundly affect the expression of long ASD (autism spectrum disorder) candidate genes.” Fluoroquinolones are topoisomerase interrupting chemicals.

Thus far, neither the increase in mitochondrial genetic diseases nor the link between topoisomerase interrupting drugs and autism have been acknowledged by the medical community, the FDA or the general public.

Fluoroquinolones Damage Mitochondria

The deleterious effects of fluoroquinolones on mitochondria have been noted repeatedly in journal articles, and even by the FDA.

In Science Translational Medicine, “Bactericidal Antibiotics Induce Mitochondrial Dysfunction and Oxidative Damage in Mammalian Cells,” it is noted that bactericidal antibiotics, including ciprofloxacin, a fluoroquinolone, “damage mammalian tissues by triggering mitochondrial release of reactive oxygen species (ROS).” Even the FDA acknowledges that fluoroquinolones cause mitochondrial damage. In their April 27, 2013 Pharmacovigilance Review, “Disabling Peripheral Neuropathy Associated with Systemic Fluoroquinolone Exposure,” the FDA notes that the mechanism for action through which fluoroquinolones induce peripheral neuropathy is mitochondrial toxicity. The report says:

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

Fluoroquinolones are very, very bad for mitochondria. As the engines of our cells, healthy mitochondria are very necessary for healthy cells. Mitochondrial dysfunction is connected with many chronic diseases, including autism, CFS/ME, fibromyalgia, Alzheimer’s Disease, Parkinson’s Disease,multiple sclerosis, etc.

Fluoroquinolones Alter Neurons

Fluoroquinolones downgrade GABA-A receptors and can lead to a variety of CNS related symptoms of fluoroquinolone toxicity such as “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,” as well as “nervousness, agitation, insomnia, anxiety, nightmares or paranoia” (Cipro warning label).

It was concluded in an article in The Journal of Neurophysiology in 1991 that, “in the presence of an anti-inflammatory agent, the quinolone antibiotics decrease the affinity of GABAA receptors, the result being induction of epileptogenic neurotoxicities.”

GABA receptors
Copyright 2009 Pharmacy Weekly, Inc. Printed with permission.

An article in Pharmacology Weekly that was published in 2009 notes that fluoroquinolones “modulate the activity of the gamma-aminobutyric acid (GABA)-A receptor” leading to the CNS side-effects of fluoroquinolones that include “tremors, restlessness, anxiety, confusion, paranoia, insomnia, etc.” and that “the presence of an NSAID or NSAID metabolite can significantly augment this effect and result in an even greater inhibition of GABA-A receptor activity” and lead to seizures, in addition to the other CNS effects listed. But, in 2015, people still are not systematically warned about the possibility of fluoroquinolone induced “nervousness, agitation, insomnia, anxiety, nightmares or paranoia” and NSAIDs are still prescribed concurrently with fluoroquinolones, despite documentation that the combination of fluoroquinolones and NSAIDs downgrade important neurotransmitters.

Though the symptoms that arise when GABA-A receptors are downgraded are noted on the warning labels for fluoroquinolones, nowhere on the warning label does it say that these effects can be long-lasting, or even permanent.

Generally, the effects of fluoroquinolones on neurotransmitters are ignored, and ensuing anxiety, insomnia and psychiatric illnesses are assumed to have nothing to do with the antibiotics that were prescribed for a sinus or urinary tract infection. The research and the warnings, have been ignored.

Fluoroquinolones Damage Cells

In The Journal of Medical Microbiology it was noted that:

“Dougherty & Saukkonen (1985) showed that inhibition of DNA synthesis by nalidixic acid, a DNA gyrase inhibitor, results in morphological changes consistent with a loss of membrane integrity and leakage of intracellular components. Similar results were presented by Wickens et al. (2000), who noticed a decrease of both membrane integrity and membrane potential after exposure of E. coli to CIP. One of the proposed explanations of this finding is that, as a result of processes induced by inhibition of DNA replication, cells lose their capacity to synthesize necessary components and to maintain the proper membrane structure (Dougherty & Saukkonen, 1985).”

Naladixic acid is the root component of all fluoroquinolones.

In case it needs to be said, cellular membrane integrity and keeping intracellular components inside cells, are important. It is important for cells as a whole, and for organelles within cells such as mitochondria. As the importance of the microbiome is being uncovered, the importance of the bacteria in our guts maintaining cellular integrity is slowly being realized as well.

Fluoroquinolones are Dangerous Drugs

The FDA warning label for Cipro/ciprofloxacin is 43 pages long. The serious and severe adverse effects listed on the warning label are due to the cellular destruction done by Cipro. Other fluoroquinolones (Levaquin and Avelox are popular) have similar safety/danger profiles.

Though no antibiotics are without consequence, the cellular destruction done by fluoroquinolones makes them far more dangerous than other antibiotics. Fluoroquinolones should be categorized as chemo drugs along with all other topoisomerase interrupters. Please be wary and cautious with fluoroquinolones, and don’t use them unless it is absolutely necessary.

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.

Participate in Research

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.

Hormones MatterTM conducts other crowdsourced surveys on medication reactions. To take one of our other surveys, click here.

To sign up for our newsletter and receive weekly updates on the latest research news, click here.

What Else Can I Do To Help?

Hormones MatterTM is completely unfunded at this juncture and we rely entirely on crowdsourcing and volunteers to conduct the research and produce quality health education materials for the public. If you’d like help us improve healthcare with better data, get involved. Become an advocate, spread the word about our site, our research and our mission. Suggest a study. Share a study. Join our team. Write for us. Partner with us. Help us grow.

To support Hormones Matter and our research projects – Crowdfund Us.

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Postpartum Fluoroquinolone Toxicity

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Sarah Flynn

In March of 2011, two months after the birth of my daughter, I experienced a bout of acute illnesses. My birth experience had been difficult, delivering five weeks early via emergency C-section after my water broke at 35 weeks gestation. My recovery was complicated by the need for an appendectomy just six weeks later. As if two abdominal surgeries weren’t enough, all of the trauma apparently dislodged two kidney stones in my right kidney. I woke up one morning with blinding pain in my stomach that migrated to my back and my side. I had passed a kidney stone once before, so I immediately knew what was causing the pain. Many who have experienced a kidney stone compare it to the pain of childbirth; I would argue that the pain is actually much worse. Unable to manage the pain on my own, I was taken to the emergency room for treatment. In the ER I was given IV pain medication and sent home with a short-term prescription for hydrocodone. I was also sent home with a prescription for a seven day course of the antibiotic Cipro. This medication was given to me as a preventative measure in case the stone ripped through my ureter.

Initial Symptoms of an Impending Cipro Reaction

About 48 hours after beginning the Cipro, I noticed an unusual feeling of nervousness. I was also having trouble regulating my internal body temperature. I would either be sweating profusely or so bone-chill cold that the only relief I could get was standing in a hot shower. I attributed these symptoms to being overwhelmed by the beating my body had taken in the last two months all while trying to care for my two month old preemie daughter. The anxiety was met with severe insomnia, and after a few days of almost complete sleeplessness (on top of the getting up with a newborn every few hours), I saw a general practitioner at a local walk-in clinic to get some advice and hopefully some relief. The doctor agreed that I was likely overwhelmed by all that had happened on top of adjusting to caring for a newborn. However, she also mentioned that I should stop taking the Cipro, and that “Cipro can do funny things” to some people. I took her advice and stopped the Cipro. Within a few days I started to feel more normal, and I shrugged off the experience. Little did I know my nightmare was just beginning.

Neurocognitive Deficits and Cipro

Two weeks later I returned to work. I was staring at the computer screen working on a research project when I noticed that my vision had become blurry. I went to the bathroom and put saline drops in my eyes when I discovered that my pupils were enormous. My eyes looked completely black instead of the normal light greenish-blue hue. I decided to leave work and go home early, and I had to squint and blink furiously just to keep my car on the road. When I returned home, my husband noticed my eyes and told me to lie down. I was exhausted, yet sleep would not come.

Cipro and the Central Nervous System

In the next few months I deteriorated rapidly, suffering from extreme anxiety, muscle twitches, myoclonus jerks, sweating, chills, weakness, tendonitis in my wrists, confusion, PVC heart arrhythmia, among roughly 30 other terrifying and painful symptoms. The worst of them, by far, was the completely intractable insomnia. I would go days at a time without being able to sleep even for one minute, finally crashing for two or three broken hours, and then the cycle would repeat itself. I sought out several doctors who ran tests after test and found nothing. I was finally steered toward psychiatry, where I was diagnosed with “anxiety” and given a slew of prescription psychiatric medications. Luckily, I declined to take most of them.

Continued Deterioration and Delayed Reactions to Fluoroquinolones

Weeks went on and my symptoms did not abate. I decided to leave my job and stay at home to take care of my precious baby daughter, the only thing giving me hope or the will to keep moving forward at that point. I was simply too sick to work, and my work environment was extremely stressful during that time. I was still very confused as to what had befallen me. After months of suffering, I remembered the doctor who had advised me to stop the Cipro. One simple Google search of “Cipro side effects” opened literally thousands of pages of information, with stories exactly like mine, of delayed reactions and unexplainable, debilitating symptoms. Because the severe symptoms were delayed for weeks after I stopped the Cipro, I never attributed my symptoms to this medication. I was unfortunately unaware that close proximity of the effect was not a necessary condition for causation when it came to pharmaceutical side effects.  However, as I began to research this class of antibiotics, called fluoroquinolones, I became aware that the most severe reactions are often delayed.

Fluoroquinolone Toxicity

I saw the top expert in the medical field on fluoroquinolone adverse reactions, and he diagnosed me with fluoroquinolone toxicity syndrome after a careful assessment. Almost a year after my first symptoms appeared, I finally had a name for my suffering. It took me almost two and a half years to recover ninety percent. My recovery focused on nutrition, stress management, and the power of positive thinking. Instead of taking medications, I found a sleep psychologist and underwent CBT for insomnia, and it helped dramatically. I still have symptoms, including the PVC arrhythmia, transient insomnia and peripheral neuropathy, but I consider myself very lucky. Many individuals with fluoroquinolone toxicity are disabled for life. You can read more about fluoroquinolone (FQ) toxicity here.

The pharmaceutical companies will lead you to believe that these side effects are rare, and therefore insignificant compared to the population of people that the drugs help. However, the truth is that most medication side effects are never reported, if they are even attributed to the drug at all. In actuality, doctors are generally uninformed about the complex array of side effects that these drugs can cause and are often unwilling to attribute patients’ symptoms back to the medications that they themselves prescribe. It is unlikely that we have an accurate picture of the side effect profiles of many prescription drugs, not just fluoroquinolones. In fact, many have speculated that a variety of idiopathic illnesses such as fibromyalgia are not organic illnesses but are all manifestations of fluoroquinolone toxicity or other adverse medication reactions. Each individual tends to have a unique threshold for toxicity, so it is entirely possible to have taken these antibiotics before without trouble only to experience a severe adverse reaction the next time they are taken. Since my diagnosis, it has become my mission to educate my friends, family and the world on FQ toxicity. Knowledge is power, and sometimes it can even be life-saving.

Participate in Research

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.

Hormones MatterTM conducts other crowdsourced surveys on medication reactions. To take one of our other surveys, click here.

To sign up for our newsletter and receive weekly updates on the latest research news, click here.

What Else Can I Do To Help?

Hormones MatterTM is completely unfunded at this juncture and we rely entirely on crowdsourcing and volunteers to conduct the research and produce quality health education materials for the public. If you’d like help us improve healthcare with better data, get involved. Become an advocate, spread the word about our site, our research and our mission. Suggest a study. Share a study. Join our team. Write for us. Partner with us. Help us grow. For more information contact us at: info@hormonesmatter.com.

To support Hormones Matter and our research projects – Crowdfund Us – Buy an Unsubscription.

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Cipro, Levaquin and Avelox are Chemo Drugs

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Lisa Bloomquist

When I first heard people referring to fluoroquinolone antibiotics (Cipro, Levaquin, Avelox, Floxin and a few others) as “chemotherapy drugs,” I thought that they were exaggerating or incorrect.  After all, fluoroquinolones are used to treat urinary tract infections, traveler’s diarrhea, anthrax, and other bacterial infections, not cancer. But then I started to do some research into how fluoroquinolones work and I discovered that they cause mitochondrial damage, which leads to oxidative stress and cell death (1, 2), they interfere with the DNA replication process of mitochondria (3), they disrupt tubulin assembly (4) and that they are being investigated for their tumor killing abilities (5, 6).  I also found that all other drugs that have the same mechanism for action as fluoroquinolones – topoisomerase interrupters (FDA warning label, 7) (topoisomerases are necessary for proper DNA replication) – are used as chemotherapy drugs – topotecan, amsacrine, etoposide, etc.  Fluoroquinolones are, truly, chemotherapy drugs – they just happen to be used as popular antibiotics. They can kill cancerous tumor cells because, in addition to killing bacterial cells, they also kill eukaryotic cells (8, 9).

Use of Fluoroquinolones for Cancer Treatment is Appropriate

There are almost certainly some legitimate and reasonable uses for fluoroquinolones as chemotherapy drugs (10).  As tumor killing agents, they may save lives of those with cancer.  Unfortunately, they’re not as targeted as the chemotherapy drugs that are currently in use.  Many chemotherapy drugs on the market specifically target quickly dividing cells – like tumor and hair cells; so they kill the cancer cells while leaving most other cells intact. Fluoroquinolones aren’t that precise. They indiscriminately kill cells throughout the body – including neurons and lymphocytes (11) (immune system cells).  The mitochondrial DNA (mtDNA) replication process is disrupted by fluoroquinolones (3), and the disruption of that process leads to mitochondrial damage, oxidative stress and cell death (12).  Fluoroquinolones are effective cell killers, but because they are indiscriminate cell killers, they are a step backward in chemotherapy drug technology.

Lousy Chemo Drugs?  Let’s Use Them as Antibiotics for Everyone!

Because they are not particularly good chemotherapy drugs, fluoroquinolones are rarely used for the purpose of killing cancer cells.  Instead, they are used as antibiotics. They are prescribed to treat sinus infections, bladder infections, strep throat, and they are even prescribed prophylactically (typically for future treatment of travelers’ diarrhea) when no infection is present. They kill bacteria, and are effective antibiotics, but they also damage mitochondria and destroy cells and therefore have many of the same side-effects as chemotherapy drugs, because, as noted above, they are chemotherapy drugs.

Side-Effects of Fluoroquinolones, and Other Chemotherapy Drugs

Some of the side-effects that fluoroquinolones share with chemotherapy drugs are (13, 14, 15, 16 and the FDA warning label for Ciprofloxacin – the warning labels for Levofloxacin and the other fluoroquinolones are similar):

  • Exhaustion / Loss of energy / Fatigue
  • Brain-fog / Loss of cognitive abilities
  • Anemia
  • Muscle Loss / Wasting
  • Neuropathy / Peripheral Neuropathy / Fibromyalgia

Additionally, Fluoroquinolones destroy connective tissue, especially tendons.  (17, 18, 19)

When one thinks of fluoroquinolones as chemotherapy drugs as opposed to antibiotics (yes, they do kill bacteria, but they should not be thought of in the same terms as benign drugs like penicillin and cephalosporins), many aspects of adverse reactions to fluoroquinolones make sense. Like several other chemotherapy drugs, there is a tolerance threshold (and/or lifetime limit) for fluoroquinolones (20, 21). Many people don’t react to their first dose of a fluoroquinolone. Rather, they tolerate the drugs up to a point – then they can no longer tolerate them and Fluoroquinolone Toxicity results. For fluoroquinolones, and possibly for other chemotherapy drugs, this tolerance threshold issue is because mitochondria are able to withstand a certain amount of damage before a disease state ensues. It is only after the tolerance threshold for damage is crossed that mitochondria stop adapting to harmful stimuli and a disease state ensues. (22)

Cellular Damage from Chemo Drugs can Lead to Cancer – Isn’t that Ironic?

Destruction of mitochondrial DNA can result in mitochondrial dysfunction and oxidative stress – which lead to apoptosis and necrosis of cells (23). When this occurs, a multi-symptom, chronic, autoimmune-disease-like reactions can occur (24, 25). However, if cell damage occurs but the cell does not die, but rather replicates the DNA errors, cancer can result (26, 27, 12).

Additionally, drugs that inhibit CYP450 liver enzymes [Cytochrome P450 enzymes metabolize xenobiotics and foreign chemicals from the body. (28)] leave people more susceptible to cancer-causing pathogens (29). Fluoroquinolones inhibit multiple CYP450 enzymes (30, FDA warning label). How ironic, isn’t it? Cancer can result from chemotherapy drugs. And when it is understood that fluoroquinolones are chemotherapy drugs that damage mtDNA and cause oxidative stress and apoptosis/necrosis, the irony of chemotherapeutic drugs causing cancer becomes horrifying, as opposed to thought-provoking.

Cellular Harm Results from Willful Ignorance About the Effects of Fluoroquinolones

There are articles that say that fluoroquinolones have an excellent safety record. (31)  None of those articles look at the effects of these drugs on the mitochondria – the depletion of mtDNA, the oxidative stress that results from damaged mitochondria, the DNA damage that is caused by the oxidative stress, etc.  In not looking at mitochondria, those articles are looking at the wrong things and they in no way negate the findings of the articles that note the deleterious effects of fluoroquinolones on human cells.

While it may be appropriate to give drugs that disrupt the process of mitochondrial DNA replication, have horrific side-effects and cause indiscriminate cell death, to people who are have cancer, it is absurd to give them to people who are healthy other than a minor infection. Even for major, difficult to treat infections, fluoroquinolones should be the drugs of last resort because of their effects on mitochondria. (1, 32)  Chemotherapy drugs should be used exclusively in life-or-death situations. They should not be used frivolously or without true informed consent of the patient, or without awareness of the consequences of the drug on the part of both the physician and the patient. Protocols should be in place for ensuring that they are used appropriately and that all parties are aware of the consequences of the drugs.

Sadly, appropriate informed consent around fluoroquinolones involves a complete shift in how physicians and patients alike think about them. In order for the risks of taking fluoroquinolones to be properly acknowledged, all parties involved need to see, and acknowledge, that fluoroquinolones are chemotherapeutic drugs that cause mitochondrial destruction and cell death, and that they should not be used lightly. But because fluoroquinolones have been given out frivolously – 26.9 million prescriptions for oral and IV fluoroquinolones were given out in 2011 alone (33) for simple infections, I don’t foresee the shift in how they are perceived as an easy one. It must involve many doctors admitting that they have been prescribing these drugs incorrectly for decades, that they have been wrong about the severity of adverse effects, and that they have been misled about the risks of fluoroquinolones.

The Effects of Drugs on Mitochondria are Systematically Disregarded

It should also be noted that the effects of drugs on mitochondria are systematically disregarded. Mitochondrial function, and drug-induced dysfunction, is important to all areas of human health.  An article published in Molecular Nutrition and Food Research entitled “Medication Induced Mitochondrial Damage and Disease” noted that the effects of drugs on mitochondria are ignored by both the drug companies and the FDA when reviewing drug safety. Because of this omission in review and oversight, human mitochondrial DNA have been repeatedly damaged by fluoroquinolones and other pharmaceuticals. The consequences of this are, as of yet, unknown. (Though it should be noted that mitochondria and the signals that they produce influence gene expression (35) and that an article published in Nature in July, 2013 entitled “Topoisomerases Facilitate Transcription of Long Genes Linked to Autism” showed that topoisomerase interrupting chemotherapy drugs effect the expression of genes linked to Autism.) We can only hope that the FDA’s failure to force drug reviewers to look at the effects of drugs on mitochondrial DNA isn’t horribly consequential.

Sources:

  1. Science Translational Medicine, “Bactericidal Antibiotics Induce Mitochondrial Dysfunction and Oxidative Damage in Mammalian Cells”
  2. British Journal of Cancer, “Ciprofloxacin Induces Apoptosis and Inhibits Proliferation of Human Colorectal Carcinoma Cells”
  3. Molecular Pharmacology, “Delayed Cytotoxicity and Cleavage of Mitochondrial DNA in Ciprofloxacin Treated Mammalian Cells”
  4. Current Medicinal Chemistry, “Recent Advances in the Discovery and Development of Quinolones and Analogs as Antitumor Agents”
  5. Inorganic Chemistry, “New uses for old drugs: attempts to convert quinolone antibacterials into potential anticancer agents containing ruthenium”
  6. Asian Pacific Journal of Cancer Prevention, “Comparative Evaluation of Antiproliferative Activity and Induction of Apoptosis by some Fluoroquinolones with a Human Non-small Cell Lung Cancer Cell Line in Culture”
  7. Mutation Research, “Ciprofloxacin:  Mammalian DNA Topoisomerase Type II Poison In Vivo”
  8. The Journal of Biological Chemistry, “Cytotoxicity of Quinolones toward Eukaryotic Cells:  Identification of Topoisomerase II as the Primary Cellular Target for the Quinolone CP-115,953 in Yeast”
  9. Antimicrobial Agents and Chemotherapy, “Effects of Novel Fluoroquinolones on the Catalytic Activities of Eukaryotic Topoisomerase II:  Influence of the C-8 Fluorine Group”
  10. Urology, “Quinolone antibiotics: a potential adjunct to intravesical chemotherapy for bladder cancer”
  11. Nepal Medical College Journal, “Genotoxic and cytotoxic effects of antibacterial drug, ciprofloxacin, on human lymphocytes in vitro”
  12. Toxicology and Applied Pharmacology, “Mitochondrial abnormalities–a link to idiosyncratic drug hepatotoxicity?”
  13. National Cancer Institute, “Chemotherapy Side Effects Sheets”
  14. The Annals of Pharmacotherapy, “Peripheral Neuropathy Associated with Fluoroquinolones”
  15. Indian Journal of Psychiatry, “Levofloxacin Induced Acute Psychosis”
  16. Journal of Antimicrobial Chemotherapy, “Peripheral Sensory Disturbances Related to Treatment with Fluoroquinolones”
  17. The American Journal of Sports Medicine, “The Effect of Ciprofloxacin on Tendon, Paratenon, and Capsular Fibroblast Metabolism”
  18. Physical Medicine and Rehabilitation (PM & R) “Musculoskeletal Complications of Fluoroquinolones: Guidelines and Precautions for Usage in the Athletic Population”
  19. Laboratorie de Toxicologie, “In Vitro Discrimination of Fluoroquinolones Toxicity on Tendon Cells:  Involvement of Oxidative Stress”
  20. Carcinogenesis, “Mechanisms of tolerance to DNA damaging therapeutic drugs”
  21. Non-Hodgekin’s Lymphoma Cyberfamily
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  26. Scitable by Nature Education, “DNA Replication and Causes of Mutation”
  27. British Journal of Haematology, “Topoisomerase II Inhibitor Related Acute Myeloid Leukaemia”
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  29. Europe Pubmed Central, “Role of cytochromes P450 in drug metabolism and hepatotoxicity.”
  30. Pharmacy Times, “Get to Know an Enzyme: CYP1A2”
  31. Expert Reviews, “Levofloxacin: update and perspectives on one of the original ‘respiratory quinolones’”
  32. Journal of Young Pharmacists, “Oxidative Stress Induced by Fluoroquinolones on Treatment for Complicated Urinary Tract Infections in Indian Patients”
  33. FDA Drug Safety Communications, “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”
  34. Molecular Nutrition and Food Research, “Medication Induced Mitochondrial Damage and Disease”
  35. BBA, “Mitochondrial DNA Damage and its Consequences for Mitochondrial Gene Expression”
  36. Nature, “Topoisomerases Facilitate Transcription of Long Genes Linked to Autism”

 

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.

Participate in Research

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.

Hormones MatterTM conducts other crowdsourced surveys on medication reactions. To take one of our other surveys, click here.

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Open Letter to Pharmacists Prescribing Fluoroquinolones – You Know!

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Dear Pharmacists,

You know about the dangers of fluoroquinolone antibiotics. You know that Cipro, Levaquin, Avelox and the other fluoroquinolones can cause central nervous system damage that can show up as anxiety, depression, memory loss, depersonalization, loss of intellect and social connectedness, suicidal ideation, etc. You know that fluoroquinolones can cause permanent destruction of all the connective tissue in a person’s body, their tendons, ligaments, fascia and cartilage. You know that adverse reactions to fluoroquinolones can be delayed and that stopping the medication will do nothing to stop its path of destruction.  You know that fluoroquinolones are contraindicated with NSAIDs and steroids. You know that they should NEVER be prescribed or administered to anyone under the age of 18.

You are pharmacists. Your expertise is in pharmaceuticals.  You have studied the chemical structure of fluoroquinolones and you know their effects, both good and bad.  You know that they are dangerous drugs that should only be used in life-or-death situations.  You know that they are over-prescribed. You know that they can have DEVASTATING adverse effects.  YOU KNOW.

Yet you continue to hand them out.  You continue to fill prescriptions with no more warning to the patient than a slip of paper in the bag that contains the poison that may shake their world.  You tell them that their infection will go away when they take the Cipro, Levaquin or Avelox.  The infection will go away but you FAIL to warn them that it may be replaced with chronic conditions that mirror autoimmune diseases, that their mental health may never be the same again, that they may never be the athletic, healthy person that they used to be.

You know that fluoroquinolones should NEVER be given to children. Yet you fill prescriptions for eye and ear drops containing fluoroquinolones for children, even BABIES.  You hand poison over to a mother with a crying 11 month-old child with an ear infection, knowing that the Cipro ear drops will get rid of that child’s infection, but that it may fry their little brain. You know. And you don’t protect the children.

You say that it’s the doctor’s job to know what he or she is prescribing, but you know that they have no clue about the dangers of fluoroquinolones. They disregard the warnings of side-effects on the drug labels, thinking that all drugs have side-effects and that they all should be disregarded because the side-effects listed are arbitrary.  There is nothing arbitrary about the litany of side-effects included with prescriptions of Cipro, Levaquin or Avelox.  You know this to be true, but the doctors don’t.  Their crime is one of willful ignorance and arrogance. They refuse to listen to anyone outside of their ranks, including you (and that’s another problem). They are ignorant, possibly through their own fault.  But you are not ignorant. You know about the dangers of fluoroquinolones. You know.

Doctors may not listen to you, but you can still do something about this moral atrocity.  Please, please, please STOP giving out these drugs. You are the gate-keepers. You can keep patients from poisoning themselves, or worse, poisoning their children. You can refuse to fill those prescriptions. You can tell doctors that they MUST follow their Hippocratic Oath and prescribe a safer antibiotic in non-life-threatening situations. You can ensure that all patients who walk away from your counter with a prescription for a fluoroquinolone have real INFORMED CONSENT. The Hippocratic Oath and Informed Consent are indescribably important. They are the moral bedrocks of the medical system, yet they are being disregarded. You can reinstate them in their appropriate place, at the top of the consciousness of every patient who deals with the medical system. You can and you should, yet you don’t.

You, as an individual, have the power to stop filling these prescriptions. You have the power to talk to the doctors that you work with, to inform them that fluoroquinolones are dangerous drugs. You have the power to talk to your patients and ensure that they have the information that they need to make a decision with true informed consent.  You have that power. Please use it to make the world a better place.

You, as a group, have the power to change the way that all drugs are viewed. You can make sure that a protocol of careful examination and active warnings to patients for all drugs that are truly dangerous is followed when prescribing and filling prescriptions of drugs with serious side-effects. You can pressure the FDA into making sure that the side-effects listed on a drug insert are real and not arbitrary so that they are actually paid attention to.

Please be moral. Do the right thing. Please be ethical. Know that your actions have consequences. They matter. Your decision about whether or not to fill a prescription of Cipro, Levaquin or Avelox can make a difference in a person’s life.

I know that the tone of this letter is scolding. Please know that my intention is not to make you feel like a horrible person, my intention is to ask you to be a better, more empowered, more ethical person.  If that is not possible, I ask you, I beg of you, please just STOP filling prescriptions of fluoroquinolones for children. They need your protection. They will thank you by living a full life without the chronic illness that plagues people who have been adversely effected by fluoroquinolones. Please, do what you can. Please do what’s right.

Thank you,

Lisa Bloomquist

Survivor

P.S. – If you’re pleading ignorance, let me ask you this question – Would you give your child a fluoroquinolone?  If your answer is no, YOU KNOW.

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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What Do Fluoroquinolone Antibiotics Have in Common With Gardasil?

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Lisa Bloomquist

Horrific side effects that are generally unrecognized by medical practitioners, that’s what these medications have in common. Gardasil Week just ended on Hormones Matter. It made me realize how many bad drugs are on the market. I had an adverse reaction to a fluoroquinolone antibiotic, Cipro, and my life changed forever. Reading the Gardasil stories, I noticed similarities amongst the adverse reactions of the fluoroquinolone antibiotics, Cipro, Levaquin and Avelox and the adverse reactions to Gardasil; both are massive, system-wide and go generally unnoticed by modern medicine.

I have to admit, I’m a bit scared about writing this post. I don’t want to be labeled as “anti-vaccine” and demonized as such. I’m not anti-vaccine. Vaccines have saved thousands of lives throughout human history. Even though an antibiotic hurt me, I’m not anti-antibiotic either. Like vaccines, antibiotics have saved thousands, possibly millions of lives.  Vaccines and antibiotics together account for so much good in modern medicine that it has become almost sacrilegious to question or criticize them – as if in questioning them one negates the lives that have been saved by them.

Rogue Players

Unfortunately, some rogue players have entered both the vaccine and the antibiotic fields; Gardasil in the vaccine market and the fluoroquinolone antibiotics, Cipro, Levaquin and Avelox, in the antibiotic market. Whether the benefits outweigh the risks of these drugs and/or whether these drugs are being used properly is a question that should be asked. Unfortunately, questioning a vaccine or antibiotic leads many to a knee-jerk reaction. Often the injured individual is accused of being anti-vax or anti-antibiotic. It is as if even asking whether or not these drugs are being properly applied and the risk are being properly assessed, is offensive;  as if, in acknowledging that there are side-effects that may not outweigh the benefits for these particular drugs, you are trying to annihilate the whole class of treatments.

I’m not, in any way shape or form, proposing that we get rid of either vaccines or antibiotics. But it would be more than nice, it would be the right, just, empathetic, loving thing to do, to listen to the stories of those who have been hurt by Gardasil or fluoroquinolones, and to explore whether or not they are the right tools to use for accomplishing what we want to accomplish – the limiting of disease and infection. Sticking one’s head in the sand and insisting that all things that come out of the pharmaceutical industry are good and pro-science is a faith-based position that is, frankly, incorrect.

People are being hurt by both Gardasil and fluoroquinolne antibiotics. Disabling, ruinous effects are coming from both of these drugs. Their lives go from normal, with nothing wrong with them in the case of those being treated by Gardasil, or having possibly only a minor infection, in the case of those prescribed fluoroquinolones, to a life of suffering with chronic health problems. This isn’t right. It’s not okay. There is nothing that is okay about turning a non-existent condition into a chronic miserable condition, or an acute condition that can be cured with mild antibiotics, and turning it into a chronic syndrome that causes pain and suffering for years to come.

Too Severe to be Real?

Reactions to both Gardasil and fluoroquinolones are often delayed, weeks to months, and so severe that they are, ironically, disregarded as absurd or impossible. If hundreds or even thousands people didn’t have similar reactions, this might be a valid argument, but when a lot of people have the same reaction of body-wide breakdown, the connection between the drug and the reaction should be seen as valid and researched as such.

Hiking before Cipro, hiking after Cipro
Greg Spooner had a toxic reaction to Cipro in 2010. Details about his story are listed below.

Maybe the incredulous attitude people display when faced with a severe adverse reaction to a pharmaceutical stems from our preconceptions about what medicines should do or how they should act.  Although, we are all aware of the risk for side-effects, we believe they “should” be mild and treatable. When, in fact, some patients develop severe reactions that are systemic, complex and difficult or impossible to treat. Rather than connecting the system-wide breakdown that the patient experiences to the drug, it is easier to believe that the cause of the person’s problems were something else, or dismiss the patient with a misdiagnosis. Rarely are the illnesses linked to the medications that caused them. When the adverse reactions are so comprehensive, they’re seen as absurd and unlikely. Worse yet, they are considered impossible to treat and often dismissed. Even if a physician recognizes the connection between the medication or vaccine and the system-wide breakdown that develops, there is very little, if anything, he or she can do to treat the syndromes that arise.

But They Save Lives

“But they save lives!” is always the argument that people make in favor of these drugs.  For fluoroquinolones, OF COURSE they save lives!  No one is arguing that they don’t.  But given the severity of the adverse effects caused by fluoroquinolones, their use should be reserved for life or death situations. Unfortunately, fluoroquinolones are used as a first line of defense against urinary tract infections, sinus infections, suspected prostate infections, travelers’ diarrhea, etc., when other, safer drugs are available and are equally effective. Giving people a drug with the potential for severe negative consequences when there are effective alternatives that don’t have the same risks is a violation of the Hippocratic Oath.

Of course, if everyone reacted as badly as I did to Cipro, or as badly as Alexis, Ashley or Nicole did to Gardasil, these drugs would be taken off the market.  Everyone would know that they are dangerous and no one would take them (except, in the case of fluoroquinolones like Cipro, in a truly life-or-death situation where there were no other alternatives). But the fact that not everyone has a horrific adverse reaction to these drugs does not negate the fact that some people do.  (And more people have bad reactions to these drugs than realize it.  Because of the delay in adverse reactions, the fact that they are under-recognized by doctors and thus an incorrect diagnosis is often made, and the absurdity of the reactions being caused by an antibiotic or vaccine, people often fail to make the connection between the cause, fluoroquinolones or Gardasil, and the reaction, a chronic syndrome of pain and destruction.)

Regardless of whether or not policy change comes as a result of the harm caused by Gardasil or fluoroquinolones, the victims of both deserve sympathy and compassion.  They deserve to be able to tell their stories. They deserve to be listened to. I can only hope that the stories are heard.

Postscript. Read more about Greg Spooner’s toxic reaction to Cipro, here.

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.

Participate in Research

Hormones MatterTM is conducting research on the side effects and adverse events associated with Gardasil and its counterpart Cervarix. If you or your daughter has had either HPV vaccine, please take this important survey. The Gardasil Cervarix HPV Vaccine Survey.

To take one of our other Real Women. Real Data.TM surveys, click here.

To sign up for our newsletter and receive weekly updates on the latest research news, click here.

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