Fluoroquinolone Antibiotics

Fluoroquinolone Antibiotics: Safety Communication – Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients

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ISSUE: FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta.  These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death.  They can occur with fluoroquinolones for systemic use given by mouth or through an injection.

BACKGROUND: Fluoroquinolone antibiotics are approved to treat certain bacterial infections and have been used for more than 30 years.  They work by killing or stopping the growth of bacteria that can cause illness.  Without treatment, some infections can spread and lead to serious health problems (see List of Currently Available FDA-Approved Systemic Fluoroquinolones).

RECOMMENDATION:
Healthcare professionals should:

  • Avoid prescribing fluoroquinolone antibiotics to patients who have an aortic aneurysm or are at risk for an aortic aneurysm, such as patients with peripheral atherosclerotic vascular diseases, hypertension, certain genetic conditions such as Marfan syndrome and Ehlers-Danlos syndrome, and elderly patients.
  • Prescribe fluoroquinolones to these patients only when no other treatment options are available.
  • Advise all patients to seek immediate medical treatment for any symptoms associated with aortic aneurysm.
  • Stop fluoroquinolone treatment immediately if a patient reports side effects suggestive of aortic aneurysm or dissection.

Patients should:

  • Seek medical attention immediately by going to an emergency room or calling 911 if you experience sudden, severe, and constant pain in the stomach, chest or back.
  • Be aware that symptoms of an aortic aneurysm often do not show up until the aneurysm becomes large or bursts, so report any unusual side effects from taking fluoroquinolones to your health care professional immediately.
  • Inform your health professional before starting an antibiotic prescription,  if you have a history of aneurysms, blockages or hardening of the arteries, high blood pressure, or genetic conditions such as Marfan syndrome or Ehlers-Danlos syndrome.
  • Not stop the antibiotic without first talking to your health care professional.

Warning: Fluoroquinolone Antibiotics May Cause Permanent Nerve Damage

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Story at-a-glance –

  • US FDA recently issued a warning that fluoroquinolone antibiotics, taken by mouth or injection, carry a risk for permanent peripheral neuropathy; Cipro (ciprofloxacin) and Levaquin (levofloxacin) are examples
  • This is not the first warning issued for this class of antibiotics; in 2008 the FDA issued a black box warning about severe tendon damage and actual tendon ruptures
  • Two other recent studies found that fluoroquinolones increase your risk for acute liver toxicity (if you’re over age 66), and destabilize your blood sugar if you’re diabetic
  • Fluoroquinolones have also been associated with memory loss, psychosis, headaches, depression, anxiety, kidney failure, cardiovascular symptoms, nausea and vomiting, blindness and other health problems
  • Fluoroquinolones are antibiotics with an attached fluoride molecule, which gives them the ability to penetrate into sensitive tissues like your brain and central nervous system, where they can exert neurotoxic effects.

Watch the video. URL:https://youtu.be/Scyd59nUG7s

The US Food and Drug Administration (FDA) recently issued a warning that fluoroquinolone antibiotics, taken by mouth or injection, carry a risk for permanent peripheral neuropathy. The safety announcement states:1

“The U.S. Food and Drug Administration (FDA) has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy.

This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent… The topical formulations of fluoroquinolones, applied to the ears or eyes, are not known to be associated with this risk.

Peripheral neuropathy is nerve damage in the arms and/or legs, characterized by “pain, burning, tingling, numbness, weakness, or a change in sensation to light touch, pain or temperature, or sense of body position.”

This is not the first warning FDA has posted about this family of antibacterial drugs. In 2008, they posted a black box warning about severe tendon damage. Now having the additional warning for severe and sometimes-permanent nerve damage, there should be NO question in your mind about the danger of these drugs, and I strongly recommend avoiding them if at all possible.

Just Say “Know”

Fluoroquinolones, a class of synthetic antibacterial drugs, are the only types that directly inhibit bacterial DNA synthesis. Several drugs in this class have been taken off the market due to their deadly adverse effects, but six of them remain FDA-approved for use in the United States:

Ciprofloxacin (Cipro) Levofloxacin (Levaquin)
Gemifloxacin (Factive) Moxifloxacin (Avelox)
Norfloxacin (Noroxin) Ofloxacin (Floxin)

 

Due to their tremendous health risks, fluoroquinolones should be reserved for treating serious bacterial infections that won’t respond to any other treatment, when the patient is made fully aware of the potential for serious adverse events. Instead, they’re often inappropriately prescribed for mild conditions like sinus, urinary tract and ear infections.

In fact, fluoroquinolones are among the most commonly prescribed antibiotics in the United States. I highly recommend you take pause before filling a prescription for these drugs, especially if you have a “routine infection” that has not been treated by other agents that have a safer side effect profile.

You should not expose yourself to this degree of risk unnecessarily! The dangerousness of fluoroquinolones definitely warrants some serious discourse with your health care provider about whether they are really necessary, versus safer treatment options.

Fluoridated Pharmaceuticals Can Be Extremely Damaging to Your Nervous System

Fluoroquinolones may be the deadliest antibiotics on the market. Besides nerve damage, they have been associated with damage to other body systems, including your musculoskeletal system, eyes and kidneys. What makes these particular drugs so hazardous?

It has to do with the fact that fluoroquinolones are antibiotics whose potency has been “kicked up” by the addition of a fluoride molecule. Fluoride increases permeability into hard-to-penetrate tissues, such as your brain.

Fluoroquinolones are quinolones with fluoride molecules attached—so they penetrate your blood-brain barrier. This ability to penetrate sensitive tissues is what makes fluoride such a potent neurotoxin, able to get into your brain and damage your central nervous system.

In terms of peripheral neuropathy, the FDA was not exactly quick to take action. Twelve years ago Dr. Jay Cohen documented the following fluoroquinolone-related reactions, and as you can see, nervous system problems topped the list.2 Yet it took more than a decade—and many destroyed lives—for the FDA to take action.

Nervous system symptoms occurred in 91 percent of patients taking fluoroquinolones (pain, tingling and numbness, dizziness, malaise, weakness, headaches, anxiety and panic, loss of memory, psychosis)
Musculoskeletal symptoms in 73 percent of patients (tendon ruptures, tendonitis, weakness, joint swelling)
Sensory symptoms in 42 percent of patients (tinnitus, altered visual, olfactory, and auditory function)
Cardiovascular symptoms in 36 percent of patients (tachycardia, shortness of breath, chest pain, palpitations)
Skin reactions in 29 percent of patients (rashes, hair loss, sweating, intolerance to heat or cold)
Gastrointestinal symptoms in 18 percent of patients (nausea, vomiting, diarrhea, abdominal pain)

 

Levaquin, the best-selling antibiotic in 2010, actually faces thousands of lawsuits per year from people who have been seriously harmed by taking it. The serious reactions reported from Levaquin include:3

Retinal detachment, which can cause blindness Hallucinations Nausea and diarrhea
Acute kidney failure Psychotic reactions Hearing problems
Brain fog Painful rashes Disruptions to blood sugar metabolism
Depression Phototoxicity Peripheral neuropathy

Fluoroquinolones Destroy Collagen

Animal studies have shown that fluoroquinolones are directly toxic to collagen synthesis and promote collagen degradation.4 Fluoride disrupts collagen synthesis, which may be part of the reason that fluoridated pharmaceuticals can damage your muscles, tendons, cartilage, ligaments and other structures.

The fluoroquinolones seem to have an especially detrimental effect on your musculoskeletal system, presumably related to this adverse effect on collagen, which can lead to tendon damage and actual tendon ruptures. This resulted in the FDA’s issuing of a black box warning about tendon damage in 2008.5 Fluoroquinolones are not the only drugs “suped up” by the addition of a fluoride molecule. Prozac (fluoxetine), Prevacid, Baycol, and Dalmane (flurazepam) are also fluorinated.6

If you or someone you love are placed on these dangerous antibiotics, for whatever reason, one of the ways you can compensate for this toxicity is by taking magnesium.  It likely binds to the drugs and prevents it from causing the collagen damage.  In fact animal studies have shown that magnesium deficient animals can develop similar damage to those exposed to fluroquinolone drugs.  Lack of extracellular magnesium impairs the function of integrins which are transmembrane proteins that connect the cells to the extracellular matrix proteins which provide the functional strength for collagen.

Are We Heading for Even MORE FDA Warnings?

Two other recent studies may foreshadow even more warnings about fluoroquinolones, in terms of liver toxicity and greater risks for people with diabetes. Are we nearing the time when these drugs should be yanked off pharmacy shelves altogether, rather than just receiving more warnings on their labels?

  • Moxifloxacin and levofloxacin were found to increase the risk for acute liver toxicity in people age 66 and up. The findings were published in the Canadian Medical Association Journal in August 2012. The authors recommended FDA consider regulatory warnings regarding acute liver toxicity.7, 8
  • Oral fluoroquinolones cause an increased risk of dysglycemia (high blood sugar or low blood sugar reactions) for those with diabetes, according to a study in the August 14, 2013 issue of Clinical Infectious Diseases.9

Fluoroquinolone Antibiotic Resistance is Much Greater than Predicted

https://dailymotion.com/video/xvxd9k&wmode=transparent

Fluoroquinolones contribute to the creation of  antibiotic-resistant bacteria to a much greater degree  than experts predicted, according to a report in Frontiers of Microbiology:10

“Since quinolones are synthetic antibiotics, it was predicted that mutations in target genes would be the only mechanism through which resistance could be acquired, because there will not be quinolone-resistance genes in nature. Contrary to this prediction, a variety of elements ranging from efflux pumps, target-protecting proteins, and even quinolone-modifying enzymes have been shown to contribute to quinolone resistance. The finding of some of these elements in plasmids indicates that quinolone resistance can be transferable…

Failure to predict the development of quinolone resistance reinforces the need of taking into consideration the wide plasticity of biological systems for future predictions. This plasticity allows pathogens to deal with toxic compounds, including those with a synthetic origin as quinolones.”

Not only are these antibiotics overused in people, but also in livestock (cows, pigs, chickens, turkeys) and in our canine and feline companions. Every year in the US, 29 million pounds of antibiotics—more than 70 percent of the total antibiotic production—are fed to livestock for nontherapeutic purposes, such as growth promotion. These antibiotics are passed on to you in the meat and dairy you consume.

Overuse of various antibiotics has been linked to antibiotic resistant infections like methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE) and the potentially life-threatening diarrhea caused by Clostridium difficile (C. diff). According to some research, being given fluoroquinolones is the most important risk factor in developing Clostridium difficile–associated diarrhea (CDAD).11

The documentary “Rise of the Superbugs” details why antibiotic overuse is leading to the emergence of nightmare bacteria that have developed near-total resistance to today’s antibiotics. Even gonorrhea and tuberculosis bacteria now have resistant strains. Again, a large part of the problem is that these drugs, which should be reserved for life-threatening infections that cannot otherwise be treated, are being vastly overprescribed. Physicians who prescribe in this manner are essentially trying to kill mosquitos with sticks of dynamite—with collateral damage as described throughout this article.

Fluoroquinolones are thought to be particularly dangerous for children under age 18, adults over 60, and pregnant and nursing women, as well as for people with liver disease, diabetes, or those taking corticosteroids or nonsteroidal anti-inflammatory drugs (NSAIDs). But, they are often prescribed for these groups anyway, without even a passing thought.

What You Can Do

If you believe you have experienced a reaction to one of these antibiotics—or any other drug, for that matter—please report it to MedWatch, the FDA’s safety information and adverse event reporting program. It is vital that they hear from each and every one of you who has experienced an adverse drug reaction. This is a major impetus in getting dangerous drugs removed from the market, and physicians almost never report the reactions themselves so it’s really up to you. MedWatch offers several reporting options:

There have been so many people damaged by fluoroquinolones that victims have banded together in a worldwide network, calling themselves “Floxies.” Quite a few Floxies are in the medical field themselves (or were, before they were poisoned), and are on a mission to help fellow fluoroquinolone poisoning victims, which is how the documentary Certain Adverse Events came about. If you haven’t already seen this film, I highly recommend it.12 For more information, you can also visit the following websites (there are many more in addition to these if you search by the term “fluoroquinolone”):

Psychiatric Side Effects of Fluoroquinolone Antibiotics

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In a survey of 94 people who experienced adverse reactions to Levaquin/levofloxacin, a fluoroquinolone antibiotic, 72% reported experiencing anxiety, 62% reported depression, 48% reported insomnia, 37% reported panic attacks, 33% reported brain fog and/or cognitive impairment, 29% reported depersonalization and/or derealization, 24% reported thoughts of suicide and 22% reported psychosis.  Case-studies and research papers also reveal that fluoroquinolone antibiotics can cause severe psychiatric adverse reactions.  Some of the studies include, Acute Psychosis Following the Use of Topical Ciprofloxacin, A Possible Case of Levofloxacin Associated Amnesia, Depression, and Paresthesia,Levofloxacin-induced acute psychosis, Ofloxacin-induced hallucinations, and others.  Fluoroquinolone antibiotics, Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin, can cause severe psychiatric adverse reactions. These psychiatric adverse reactions, like other adverse reactions to fluoroquinolones that are encompassed in fluoroquinolone toxicity syndrome, can be long-lasting and are sometimes permanent.

Petitioning the FDA about Fluoroquinolone Safety

A citizen petition has been submitted to the U.S. Food and Drug Administration (FDA) requesting that increased warnings about the severe psychiatric effects of Levaquin/levofloxacin be added to the official warning labels. The petition, which was submitted by Dr. Charles Bennett of the Southern Network on Adverse Reactions (SONAR), requests that a black box warning about serious psychiatric adverse events be added to the Levaquin/levofloxacin warning label. Black box warnings are the “strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects.”

Psychiatric Side Effects of Fluoroquinolone Antibiotics: From the Survivors

The psychiatric adverse effects of fluoroquinolones are severe, life-altering and sometimes life-threatening. People with no history of psychiatric problems have experienced depression, paranoia, psychosis, anxiety, etc. after taking fluoroquinolone antibiotics. Traci describes the effects of Cipro on her mental and physical health as follows:

“It has almost been 3 years since I took a 30 day supply of Cipro for a UTI and just like most of the stories, my life has changed drastically. First came the weakness and fatigue, enough to where I would sleep for days and started wrapping my wrists, arms and feet with k tape on a daily basis. My eye sight started going bad very quickly, and just constant tingling, numbness, brittle, depression that I couldn’t control, loss of balance, anxiety, panic attacks, insomnia that lasted for days at a time, nightmares.

I’ve  lost a couple of years with my children and husband that I will never get back. I left a very good job/company thinking stress was the cause and went to another smaller company only to get let go a few months after starting as I couldn’t make it to work every day.

My first doctor seemed angry when I asked her if the Cipro could be the cause and made me feel like an idiot. I went to holistic doctor, didn’t mention the Cipro this time as I thought I was wrong about the cause. She diagnosed me with fibromyalgia  and chronic fatigue syndrome and wanted to run tests to find toxins in my system, but due to job loss I could no longer afford. She was on the right track and I’m grateful for the things she has taught me in my short time with her, but I am still down more days than I am up and I lost a really good salary that has put pressure on my whole family. Finally when I heard FDA announced the link to peripheral neuropathy and started reading about what Cipro has done to others I at least know I am not crazy.”

Traci’s story of multiple psychiatric symptoms, including depression, anxiety and panic attacks, and the effects of those symptoms on her life, are unfortunately familiar for many people who have taken fluoroquinolones. Another victim of Cipro/ciprofloxacin, Ruth, reported:

“A couple days after stopping the Cipro, I experienced terrifying panic attacks every time I fell asleep. It was like being shoved down into hell: a place of loneliness and terror. I had never felt fear and hopelessness like that. It was like being thrust into a horrible place from which there was no escape.”

The adverse psychiatric effects of fluoroquinolones can seem to come out of nowhere, with panic and anxiety attacks striking while doing normal activities like watching television, driving, or falling asleep. Adverse reactions to fluoroquinolones are often delayed for weeks or even months after administration of the drugs has stopped; leaving victims and physicians alike with difficulty connecting the drugs to the ensuing psychiatric problems.

Serious and Life Altering Psychiatric Side Effects

The psychiatric symptoms described by Traci and Ruth are serious and life-altering. Neither physicians nor patients currently have adequate information about the severity of adverse psychiatric effects caused by fluoroquinolone antibiotics because the psychiatric effects are currently buried in the “Central Nervous System Effects” heading of the warning label. As the citizen petition notes, these effects should have their own heading and a black box warning. Perhaps when a black box warning of serious psychiatric events is added to the warning labels for Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin it will be realized that people who are suddenly suffering from panic and anxiety attacks, insomnia, paranoia, excessive fearfulness, psychosis, bipolar disorder, etc. after taking a fluoroquinolone aren’t suddenly crazy or deciding to be difficult, they’re suffering from fluoroquinolone toxicity syndrome – an iatrogenic disease and a tragic assault to victims’ bodies and minds.

I hope that the FDA responds to Dr. Bennett and SONAR’s call for increased warnings about the psychiatric effects of fluoroquinolones by both adding the warnings requested, and by restricting the rampant use of fluoroquinolones when other, safer, antibiotics are available. Loss of mental health is not an appropriate price to pay for treatment of a urinary tract infection, traveler’s diarrhea, sinus infection or any other infection that isn’t life-threatening.

About the Author:  Lisa Bloomquist was “Floxed” on her 32nd birthday by Cipro, a fluoroquinolone antibiotic. After 2 years of battling the mysterious health ailments that come with an adverse reaction to a fluoroquinolone, she has fought her way back to health. She is now fighting for recognition of the harm that these drugs can cause and hoping to help those who are suffering from them through their fluoroquinolone induced illness to find recovery. Her web site, Floxie Hope, highlights stories of hope and recovery. Mito Madness, also started by Lisa, focuses on the absurdity of ignoring the role of mitochondria in forming disease models.