evidence based medicine

What is required for fluoroquinolone toxicity to be “real?”

Most of the symptoms of fluoroquinolone toxicity are listed on the warning labels.

Tendinitis? Yup, listed on the warning label. Muscle weakness? Yup, that’s there too. Cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching? They’re right there on the warning label. Liver failure is there too – that’s what “hepatic failure” means. “Convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis have been reported in patients receiving fluoroquinolones, including ciprofloxacin.” Serious central nervous system effects like, “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” are also listed on the warning labels. Permanent peripheral neuropathy is listed too. So are musculoskeletal disorders—though the warning label only notes that those happen in pediatric patients—kids. Prolongation of the QT interval, renal impairment, phototoxicity and diarrhea are also listed.

Do the warning labels leave some symptoms of fluoroquinolone toxicity out? Sure. Even the FDA acknowledges that, “While most of the individual AEs (adverse effects) that exist within FQAD (fluoroquinolone associated disability) are currently described in fluoroquinolone labeling, the particular constellation of symptoms across organ systems is not.” The warning labels are a good place to start though.

If someone takes a drug, then develops side-effects that are listed on the drug warning label, it’s pretty reasonable to think that what they’re experiencing is an effect of the drug. It’s not only reasonable, it’s probable.

If thousands of people experience similar adverse effects after taking a drug, those adverse effects are likely caused by the drug.

Thousands of anecdotes certainly help to build a case, but they are still anecdotes, so scientific experimentation is needed to show that a drug is as damaging and dangerous as people claim it to be.

There are more than 200 peer-reviewed journal articles about fluoroquinolones in the Research section of the Links & Resources page on this site. There is PLENTY of evidence that fluoroquinolones do a massive amount of damage to the human body.

There is PLENTY of evidence that fluoroquinolones damage mitochondria, increase ROS, deplete antioxidants, deplete iron, deplete magnesium, damage the microbiome, downgrade GABA, are endocrine disrupters, cause lysosomal disorders, form poisonous metabolites in the liver, activate mast cells and release histamine, AND MORE.

Can any one of those things cause a multi-symptom illness? Yes, of course they can. And fluoroquinolones DO cause multi-symptom, often chronic, illness.

Despite all that, there is not a diagnostic code for fluoroquinolone toxicity, and fluoroquinolone toxicity is not taught in medical school. Many doctors do not recognize fluoroquinolone toxicity when they have a patient who is dealing with it. (Though that is changing—more and more doctors are recognizing fluoroquinolone toxicity, and that is a very good thing.) And, despite all the damage that fluoroquinolones do to cells, there is no test that shows fluoroquinolone toxicity.

A diagnostic code and a test will likely be required for some people to believe that fluoroquinolone toxicity is real. We should fight for those things, because they’re important in getting the problem recognized and the solution sought.

Even without the diagnostic code or adequate test, fluoroquinolone toxicity IS REAL. It is acknowledged in FDA documents and backed up by hundreds of peer-reviewed articles. If someone chooses to ignore that evidence, well, they’re operating on faith in their notions of infallible doctors, not the real, scientific evidence that shows the damage that fluoroquinolones do to cells.

Regardless of what anyone thinks, your pain and your experience are real. I know that it hurts when people assert that your pain isn’t real, or that you’re imagining what you know to be true. It sucks, to say the least. But you know your body, and you know what happened to you. Your truth, and your experience, matter. Other people’s beliefs about your condition don’t.

Cipro is no better than a PLACEBO at treating chronic prostatitis / chronic pelvic pain syndrome

It is noted in the book, A Headache in the Pelvis, that, “Ciprofloxacin, one of the most powerful antibiotics, on a long-term basis proves to be only as effective as a placebo” for treatment of chronic prostatitis / chronic pelvic pain syndrome (CP/CPPS).

I just about fell out of my chair when I read that.

Ciprofloxacin, not only one of the most powerful antibiotics, but also one of the most dangerous antibiotics, is NO MORE EFFECTIVE THAN A PLACEBO for treatment of chronic prostatitis. Despite their lack of effectiveness, “Quinolones, such as ciprofloxacin, are commonly used to treat CP/CPPS because of their excellent penetration into the prostate.”

Ciprofloxacin penetrates the prostate, and every cell in the body well, but that doesn’t seem like a good enough reason to give it out to the 9-12% of men who suffer from prostatitis if it is NO MORE EFFECTIVE THAN A PLACEBO in treating chronic prostatitis.

Let’s do a cost/benefit analysis of ciprofloxacin versus a placebo.

Placebo

Benefits: Some potential alleviation of symptoms, as well as potential increases in physical and mental health scores. (The placebo effect is amazing – it’s not the same as doing nothing.)

Costs: The potential for “nocebo” effects exists – the experience of adverse effects based on the expectation of adverse effects. A placebo is a sugar pill though, and the potential for adverse effects is negligible.

Ciprofloxacin

Benefits: Some potential alleviation of symptoms, as well as potential increases in physical and mental health scores. (Same potential benefits as the placebo.)

Costs: Ciprofloxacin and other fluoroquinolones can kill people – DEATH is a potential effect. If they don’t kill the patient, they can still structurally weakening of every tendon in one’s body, cause mitochondrial dysfunction and potentially increase the risk of all of the diseases related to mitochondrial dysfunction (including neurodegenerative and autoimmune diseases), lead to serious central nervous system adverse effects including seizures, anxiety, depression, suicidal ideation and intracranial pressure, cause liver and kidney failure, PERMANENT peripheral neuropathy, and more. There is a 43 PAGE warning label for ciprofloxacin. Many things are missing from the warning label, and a list of some of the adverse effects can be found HERE. When patients are given ciprofloxacin, they are not only risking a single adverse effect listed on the warning label, they are risking multiple, devastating effects that may be permanent.

Opting for the sugar pill seems pretty reasonable—better, actually.

It is criminal to subject people to a drug as dangerous as ciprofloxacin for a condition that it isn’t effective at treating. It is NOT a benign drug. It is a topoisomerase interrupter – a chemo drug – and it should NOT be used frivolously. Ciprofloxacin, and all the other fluoroquinolones, should only be used in life-threatening situations and they should NEVER be used for conditions that they are not proven effective at treating. They should NEVER be used in situations where they have been shown to be no more effective than a placebo.

This isn’t rocket science. Don’t give people dangerous drugs that don’t even have the potential for helping them. It’s not hard. But men with CP/CPPS are given ciprofloxacin, and other fluoroquinolones, as if they’re candy, to “treat” their condition. It’s absurd.

The study that found that CP/CPPS is no more effective than a placebo was published in the Annals of Internal Medicine in 2004 and it was entitled “Ciprofloxacin or Tamsulosin in Men with Chronic Prostatitis / Chronic Pelvic Pain Syndrome: A Randomized, Double-Blind Trial.” The article notes that:

“Chronic prostatitis / chronic pelvic pain syndrome (CP/CPPS) is a common disorder and accounts for approximately 2 million visits to physicians annually in the United States. The substantial impact of CP/CPPS includes bothersome lower urinary tract symptoms, sexual dysfunction, reduced quality of life, and increased health care expenditures. The syndrome is diagnosed only on the basis of symptoms, principally pain or discomfort in the pelvis region. No objective measures can help define the disease. Although bacteria can infect the prostate, most men with prostatitis have a negative midstream urine culture, indicating that bacteria may not be the cause of their symptoms.”

“Because the cause of CP/CPPS is unknown, affected men receive many empirical therapies. The 2 most common treatments prescribed by physicians are antimicrobial agents and a-adrenergic receptor antagonists, although there is little objective evidence to support their use. Quinolones, such as ciprofloxacin, are commonly used to treat CP/CPPS because of their excellent penetration into the prostate and broad spectrum coverage for uropathogens and other organisms traditionally believed to be associated with the syndrome.”

After completing a randomized, double-blind trial on men suffering from CP/CPPS, and comparing those who received ciprofloxacin, tamsulosin, a combination of both ciprofloxacin and tamsulosin, and a placebo, it was concluded that, “Ciprofloxacin and tamsulosin did not substantially reduce symptoms in men with long-standing CP/CPPS who had at least moderate symptoms.”

Ciprofloxacin, and other antibiotics, are given to men with non-bacterial prostatitis for no good reason whatsoever. They are often given long courses as well – 6 to 12 weeks of the drugs. That’s a long enough course for many of the men who are given these drugs to cross their tolerance threshold for the drugs and get floxed.

If ciprofloxacin was effective at treating CP/CPPS, perhaps it would be worth the risk of getting floxed. But ciprofloxacin isn’t effective at treating CP/CPPS. It’s no more effective than a sugar pill and it is beyond ridiculous and wrong to expose men to a dangerous drug that doesn’t even help them.

CP/CPPS has been shown to be treatable through the techniques outlined in A Headache in the Pelvis: A new understanding and treatment for prostatitis and chronic pain syndromes. The effective treatments include trigger point therapy and concomitant relaxation training. More information about the treatments can be found in the article, “6-Day Intensive Treatment Protocol for Refractory Chronic Prostatitis/Chronic Pelvic Pain Syndrome Using Myofascial Release and Paradoxical Relaxation Training,” as well as on the web site http://www.pelvicpainhelp.com/.

Many symptoms of CP/CPPS, and other pelvic pain syndromes, react well to relaxation training and appear to be a response to stress and anxiety. “Chronic pelvic pain reflects tension in the pelvic floor, initiated or exacerbated by cycles of mental tension, anxiety and stress.” Pelvic pain syndromes are no more a choice than other bodily manifestations of stress such as heart attacks, back pain or tension headaches. The pain is real and it is not “in the patient’s head.” The brain is not separate from the body though, and what is going on in the head can have bodily manifestations.

The effects of ciprofloxacin, and other fluoroquinolones, on neurotransmitters may exacerbate CP/CPPS and other diseases related to stress and anxiety. Fluoroquinolones block GABA-A receptors. GABA receptors are the neurotransmitters that induce a calming response. When GABA receptors are blocked by fluoroquinolones, anxiety, insomnia, fearfulness, loss of confidence, loss of self, psychiatric illness and even seizures can result. Floxed patients often report being unable to relax, a reduced threshold for stress, autonomic nervous system dysfunction, and other symptoms of GABA neurotransmitter dysfunction. Fluoroquinolones activate the sympathetic nervous system and disrupt the balance between the sympathetic and parasympathetic nervous systems.

If CP/CPPS is primarily a response to anxiety, stress and disregulation of the sympathetic/parasympthetic nervous systems, ciprofloxacin may not only fail to improve chronic pelvic pain conditions, it may exacerbate them.

Prescribing ciprofloxacin, or any other fluoroquinolone, to patients with chronic pain and non-bacterial prostatitis, is not only not helpful – IT IS HARMFUL, and may exacerbate the condition it is prescribed to treat.

Post-script note – Many people, especially elderly women, are given fluoroquinolones to treat asymptomatic urinary tract infections after a urinalysis shows bacteria in their urine. It has recently been noted that URINE ISN’T STERILE. And again, people are getting floxed for no good reason.

Sources:

A Headache in the Pelvis, a New, Revised, Expanded and Updated 6th Edition: A New Understanding and Treatment for Chronic Pelvic Pain Syndromes by David Wise and Rodney Anderson

Alexander RB, et al. “Ciprofloxacin or tamsulosin in men with chronic prostatitis/chronic pelvic pain syndrome: a randomized, double-blind trial.” Annals of Internal Medicine, 2004 Oct 19;141(8):581-9.

Anderson RU, et al. “6-day intensive treatment protocol for refractory chronic prostatitis/chronic pelvic pain syndrome using myofascial release and paradoxical relaxation training.” The Journal of Urology, 2011 Apr;185(4):1294-9. doi: 10.1016/j.juro.2010.11.076. Epub 2011 Feb 22.

“What is the mechanism by which the fluoroquinolone antibiotics (e.g., ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin) can increase a patient’s risk for developing a seizure or worsen epilepsy?” Pharmacology Weekly, ©2008 – 2014 Pharmacology Weekly, Inc.