Monthly Archives: October 2015

Is Fluoroquinolone Toxicity “Real?”

Invisible Illness Real

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.

 

 

flu tox get help you need banner click lisa

 

An Official Name: Fluoroquinolone-Associated Disability (FQAD)

FDA report fluoroquionlone associated disability

For the FDA’s November 5, 2015 meeting to review “The Benefits and Risks of Systemic Fluoroquinolone Antibacterial Drugs for the Treatment of Acute Bacterial Sinusitis (ABS), Acute Bacterial Exacerbation of Chronic Bronchitis in Patients Who Have Chronic Obstructive Pulmonary Disease (ABECB-COPD), and Uncomplicated Urinary Tract Infections (uUTI)” a 617 page report was released by the FDA. You can access it HERE if you want to read it in its entirety.

In the last post, I noted that the FDA report said that fluoroquinolones have not been shown to be any better than a placebo at treating sinus infections, bronchitis in those with COPD, or uncomplicated urinary tract infections. In this post, I will point out that the FDA has given those suffering from fluoroquinolone toxicity an official name. Per the report:

“A review of the FDA Adverse Event Reporting System (FAERS) was performed to characterize a constellation of symptoms leading to disability that had been observed during FDA monitoring of fluoroquinolone safety reports. This constellation of symptoms will be referred to in this review as ‘fluoroquinolone-associated disability’ (FQAD). While most of the individual AEs that exist within FQAD 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 recognition from the FDA is EXCELLENT progress!

I don’t know whether or not FQAD will be put into diagnostic manuals, or if it will be coded for in insurance systems. I hope that those are future steps that will be taken.

So far, in the first 20 pages of the 617 page FDA report, they have noted that fluoroquinolones are no more effective than placebos in treatment of sinus infections, bronchitis in those with COPD, and uncomplicated urinary tract infections. They have also noted that fluoroquinolones can cause a constellation of symptoms across multiple body systems, and that those symptoms can lead to disability.

It is not appropriate to cause, or even to risk, disabling adverse effects through utilization of a drug that is no more effective than a placebo at treating sinus infections, bronchitis in those with COPD, and uncomplicated urinary tract infections. I hope that the FDA changes the recommended uses for fluoroquinolones in recognition of this.

I hope that the naming of FQAD increases recognition of the horrible adverse effects of fluoroquinolones. With recognition, hopefully a more prudent and appropriate approach to use of fluoroquinolones will occur.

Post-publishing edit – While it is a wonderful step in the right direction that the FDA acknowledged that fluoroquinolones can cause a constellation of symptoms that is not adequately noted in the warning label, I may have jumped the gun a bit in calling it an “official” name. FQAD is the term that the FDA is using for the purposes of the November 5th hearing. It is not a diagnostic code that your doctor can look up in his or her diagnostic manuals yet. I hope that it’s a step in that direction, but we’re not there yet. Celebrating the FDA acknowledgement is in order, but we still have a ways to go. I apologize for not being more clear in the post before I originally published it!

 

flu tox get help you need banner click lisa

 

The FDA Notes that Fluoroquinolones are no Better than Placebos

Fluoroquinolone Toxicity Pill Picture

For the FDA’s November 5, 2015 meeting to review “The Benefits and Risks of Systemic Fluoroquinolone Antibacterial Drugs for the Treatment of Acute Bacterial Sinusitis (ABS), Acute Bacterial Exacerbation of Chronic Bronchitis in Patients Who Have Chronic Obstructive Pulmonary Disease (ABECB-COPD), and Uncomplicated Urinary Tract Infections (uUTI)” a 617 page report was released by the FDA. You can access it HERE if you want to read it in its entirety.

In the next several posts, I will summarize and comment on the report. The following is post 1 of the summary/commentary:

The report starts by noting that fluoroquinolones have never been shown to be safe or effective treatments for sinusitis, bronchitis for those with COPD, or uncomplicated urinary tract infections. No placebo-controlled trials were conducted when approving fluoroquinolones as treatments for these diseases. Per the FDA:

“Antibacterial drugs approved before the 1980s were in general used as the control antibacterial drugs in NI trials. Because placebo-controlled trials were not used as a basis for the approval of those drugs, a treatment effect of the control antibacterial drugs over placebo had not been clearly established for ABS, ABECB-COPD, or uUTI. Thus, these active-controlled studies may not provide a reliable means to evaluate efficacy of antibacterial drugs for these indications.”

No placebo-controlled studies were used for approval of fluoroquinolones (or any other antibacterial drugs, apparently) in the treatment of sinus infections, bronchitis for those with COPD, or uncomplicated urinary tract infections. It’s just now occurring to the FDA that without placebo-controlled trials, they may not have reliable evidence of the efficacy of these drugs. Ya think?

The report goes on to note that the Cochrane Collaboration concluded the following about treatment of sinusitis with antibiotics:

“The Cochrane Collaboration conducted a review of antibacterial drugs for treatment of clinically diagnosed acute rhinosinusitis in adults and provided this statement in their conclusion: ‘Taking into account antibiotic resistance and the very low incidence of serious complications, we conclude that there is no place for antibiotics for the patient with clinically diagnosed, uncomplicated acute rhinosinusitis’ (Lemiengre, van Driel, et al, 2012).”

Additionally, regarding bronchitis in those with COPD, the FDA report notes that, “Clinical practice guidelines for treatment of ABECB-COPD published by the American College of Physicians stated, ‘Among patients with mild attacks, there were no significant differences between those who received antibiotics and those who received placebo.’”

fluoroquinolone-lawsuit-banner-trulaw

The case regarding uncomplicated urinary tract infections is a bit more convoluted, but the report does note that, “In a study (of patients with uncomplicated urinary tract infections) that used ibuprofen as a control, there was no treatment difference on symptom resolution in comparison to an antibacterial drug.”

We rely on the FDA to evaluate drugs to make sure that they are safe and effective. Fluoroquinolones are far from safe—they lead to multiple musculo-skeletal and nervous system adverse effects (most of which are described in the 43 page warning label for Cipro/ciprofloxacin). I was assuming that they were at least effective. It turns out that fluoroquinolones are no more effective than a placebo at treatment of sinus infections, bronchitis or uncomplicated urinary tract infections. (They’re no more effective than a placebo at treating prostatitis either – see THIS POST.) People are getting poisoned and severely hurt by fluoroquinolones–for no good reason. Fluoroquinolones are no more effective than a placebo at treating many of the conditions they are prescribed for, and people would be far better off taking a sugar-pill than they are taking a topoisomerase interrupting chemo drug that is no more effective than a placebo.

The FDA approved fluoroquinolones for use in treatment of sinus infections, bronchitis for those with COPD, and uncomplicated urinary tract infections based on the assumption that they were safe and effective, not on actual studies showing that assumption to be true. They are not safe, and they are no better than a placebo for treatment of these conditions. For more than 30 years, the FDA has been using false assumptions and faith, rather than evidence established by placebo-controlled trials, as the basis for approving dangerous drugs for treatment of benign infections that the body can fight off using its immune system (or a placebo).

The mantra of “all drugs have side-effects” is often spewed by people who think that side-effects are acceptable. But with any veil of acceptability comes the assumption that dangerous drugs are at least effective. Fluoroquinolones aren’t even effective at treating sinusitis, bronchitis or uncomplicated UTIs—diseases that they are prescribed for thousands of times every day. They are no better than a placebo at treating those conditions. They are neither safe nor effective and people would be better off taking snake oil than they are taking ineffective drugs that deplete mitochondrial DNA and lead to tendon ruptures, permanent peripheral neuropathy, serious central nervous system adverse effects, and more.

Fluoroquinolones are neither safe nor effective. Every person who has been hurt by a fluoroquinolone taken to treat sinusitis, bronchitis or an uncomplicated UTI was hurt because of the FDA’s ineptitude and their inability to realize that antibiotics need to go through placebo-controlled trials just like every other drug.

This situation, where the FDA approves unsafe and ineffective snake-oils to be sold by the pharmaceutical juggernauts as long as they are labeled as “antibiotics,” is only going to get worse with the passage of the 21st Century Cures Act. The 21st Century Cures Act will encourage the production of new antibiotics, regardless of their safety profile or mechanism of action. In an op/ed article in the New England Journal of Medicine, it is noted that:

“The proposed legislation would make immediate changes with respect to new antibiotics and antifungals by enabling their approval without conventional clinical trials, if needed to treat a ‘serious or life-threatening infection’ in patients with an ‘unmet medical need.’ In place of proof that the antimicrobial actually decreases morbidity or mortality, the FDA would be empowered to accept nontraditional efficacy measures drawn from small studies as well as ‘preclinical, pharmacologic, or pathophysiologic evidence; nonclinical susceptibility and pharmacokinetic data, data from phase 2 clinical trials; and such other confirmatory evidence as the secretary [of health and human services] determines appropriate to approve the drug.’ Antimicrobials approved in this manner would carry disclaimers on their labeling, but there is no evidence that such a precaution would restrict prescribing to only the most appropriate patients. If passed in its current form, the bill would also provide hospitals with a financial bonus for administering costly new but unproven antibiotics, which could encourage their more widespread use. The bill gives the secretary of health and human services the authority to expand this nontraditional approval pathway to other drug categories as well, if “the public health would benefit from expansion.”

Don’t think for a second that the FDA is keeping snake-oils off the market. They’ve been allowing drugs that are more dangerous than snake-oils, and no more effective, to be sold to the American public for years.

I hope that they at least try to undo some of the damage done in the November 5th meeting. We shall see.

flu tox get help you need banner click lisa

I’m Floxed. Now What?

Fluoroquinolone Toxicity First Steps

When I got floxed in 2011 there was less than 1/10th the information about fluoroquinolone toxicity available that there is now. The information available about fluoroquinolone toxicity has increased exponentially over the last few years–and with increasing information comes greater acknowledgement of the problem, empowerment of those going through fluoroquinolone toxicity, and more. I am grateful to everyone (both the scientists and doctors, whose acknowledgment is necessary for change, and also those citizen-scientists and hackers—who are trying to figure out what happened in their bodies) who have contributed their time, expertise, and sleuthing abilities, to gather and synthesize information about fluoroquinolone toxicity to share with others! We truly have come a long way.

The amount of information available about fluoroquinolone toxicity is getting to a point where it is somewhat overwhelming. People are now asking, “Where do I start?” because a starting point isn’t evident.

Here are my suggestions for where to start:

First, read through the recovery stories on www.floxiehope.com. Every healing story is different. The journey through fluoroquinolone toxicity has not been the same for any two people. Even though each story is different, each story has some valuable wisdom and guidance in it. As you’re reading through the stories, I suggest that you write down the healing tips and steps that resonate with you. Try those things one-by-one and see if they work as well for you as they do for the person who recovered from fluoroquinolone toxicity and wrote the story.

Second, the ebook, The Fluoroquinolone Toxicity Solution*, has helped many people through fluoroquinolone toxicity, including Ruth, Cindy, Lizzy and Daniel. It gives particularly good guidance for those looking for supplements to help them to heal from fluoroquinolone toxicity.

You can find support, guidance and advice through many web sites and social-media groups. Comments on the home page of floxiehope.com are typically responded to quickly and there is a wealth of information in the past comments. The Fluoroquinolone Toxicity Group on Facebook is also an excellent resource for support and information that also has years of helpful posts stored on it. (Try not to get overwhelmed by these sites, and if you do get overwhelmed by them, I recommend that you step away from them until you are emotionally able to handle being on them.)

The Floxie Food Guide: Guidelines for Recovery from Fluoroquinolone Toxicity contains information about diets that have helped people through fluoroquinolone toxicity. (Renee was helped immensely by The Wahls Protocol by Dr. Terry Wahls). It also contains guidance for foods to eat to help your mitochondria to heal, your gut microbiome to heal, and also foods that are full of minerals that fluoroquinolones deplete. (Note – You now get The Floxie Food Guide along with the purchase of The Fluoroquinolone Toxicity Solution. Yay! Please click on the link below to get both. Thanks!)

I wrote the following posts to give people basic information about fluoroquinolone toxicity:

Additionally, the post, Articles About Fluoroquinolone Toxicity to Give to Your Doctor, links to several articles about fluoroquinolone toxicity that give a good overview of the condition. More articles can also be found on the Links & Resources page of floxiehope.com (but there are literally hundreds of articles linked to on that page, and the amount of information there can be overwhelming).

There are doctors who have helped people through fluoroquinolone toxicity. If you find a good doctor who you trust to be your guide, he or she can be incredibly valuable. There is a list of doctors who have been positively reviewed by fellow-floxies on the post, “Doctor Referral List.” Additionally, many floxies have been helped by functional medicine doctors. You can find a functional medicine doctor in your area through The Institute for Functional Medicine.

Those are the initial steps I recommend for gathering information on how to recover from fluoroquinolone toxicity. I wish that there were a single cure, or method, or procedure, that helped everyone to recover from fluoroquinolone toxicity. It would be nice if we could say, “take ___ milligrams of ____ per day for ___ days and you will recover,” or “eat _____ and _____ for breakfast and you will recover,” or, “Do _____ exercises and you will recover,” but we can’t say those things because there is no one single cure for fluoroquinolone toxicity. There is, however, recovery from fluoroquinolone toxicity for many people—and there is information that is helpful for your recovery journey throughout this site and other places on the internet.

I hope this post gives you some help with direction.

Please let me know if you need assistance. Hang in there.

*Affiliate Link

flu tox get help you need banner click lisa

 

Speaking at the Nov. 5 FDA Meeting About Fluoroquinolones

Speaking at the Nov. 5 FDA Meeting About Fluoroquinolones

Please see the following for information about how to speak at the November 5, 2015 FDA meeting. Please contact Jennifer via the contact information listed below in order to sign up to be a speaker. Thank you to all who are willing to speak at the meeting!

On November 5, 2015, the committees will discuss the risks and benefits of the systemic fluoroquinolone antibacterial drugs for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease, and uncomplicated urinary tract infections in the context of available safety information and the treatment effect of antibacterial drugs in these clinical conditions.

Meeting  location:

FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center
The Great Room (Rm. 1503)
Silver Spring, Maryland

Oral presentations from the public will be scheduled between approximately 1:00 p.m. and 2:30 p.m. on November 5, 2015. Please note that we will be accepting requests to speak at the Open Public Hearing session of this meeting through October 14, 2015.  If the unusual situation arises where more people wish to speak than can be reasonably accommodated during the scheduled Open Public Hearing session, we will conduct a lottery to identify (via a random process) those who will be speaking.  You/the speaker will be notified (by e-mail) on October 15, 2015 to confirm the request to speak.

In the meantime, please provide us the following information:

• Full contact information, including address

• Brief statement of the general nature of the evidence or arguments you wish to present

• Amount of time requested

• Any audio/visual requirements

• The organization(s) you will be representing, if any

Please let me know if you have any questions.  Thank you for your interest in the FDA’s Antimicrobial Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee.

Kind Regards,

Jennifer Shepherd, RPh.
LCDR, USPHS
Designated Federal Officer, AMDAC, Food and Drug Administration (FDA),Center for Drug Evaluation and Research (CDER), Office of Executive Programs (OEP), Division of Advisory Committee and Consultant Management (DACCM)
White Oak Building 31, Room 2417
10903 New Hampshire Avenue
Silver Spring, MD 20993
Main Telephone: (301) 796-9001 – Fax: (301) 847-8533
Email: AMDAC@fda.hhs.gov

 

flu tox get help you need banner click lisa

 

Advocacy Opportunity – FDA Meeting to Discuss Fluoroquinolones

Advocacy Opportunity - FDA Meeting to Discuss Fluoroquinolones

ADVOCACY OPPORTUNITY 

The FDA (Food and Drug Administration) is holding a meeting on November 5, 2015 to discuss the benefits and risks of fluoroquinolones. Per the FDA notice, the agenda for the meeting is:

“The committees will discuss the risks and benefits of the systemic fluoroquinolone antibacterial drugs for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease, and uncomplicated urinary tract infections in the context of available safety information and the treatment effect of antibacterial drugs in these clinical conditions.”

They are opening the meeting for public testimony and if you are in the Silver Spring, Maryland area I encourage you to attend the meeting and to testify at it. (I would love to go, but I’m in Colorado, so not exactly nearby.)

They are also accepting written testimony. Please send your story/testimony to Jennifer Shepherd, the contact person, by October 22, 2015. Jennifer’s contact information is:

Jennifer Shepherd, RPh.
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
WO31-2417
Silver Spring, MD 20993-0002
Phone: 301-796-9001
Fax: 301-847-8533
E-mail: AMDAC@fda.hhs.gov

PLEASE take the time to tell your story to the FDA. The adverse effects of fluoroquinolones are too severe for it to be appropriate for them to be used for sinusitis or uncomplicated urinary tract infections. This is your opportunity to share your story directly with the FDA, and the committee that determines how fluoroquinolones are used.

More information can be found in these announcement links –

http://www.fda.gov/AdvisoryCommittees/Calendar/ucm465275.htm

https://www.federalregister.gov/articles/2015/10/01/2015-24836/joint-meeting-of-the-antimicrobial-drugs-advisory-committee-formerly-known-as-the-anti-infective

THANK YOU!!!

 

flu tox get help you need banner click lisa

Can Fluoroquinolones Activate Mast Cells?

Can Fluoroquinolones Activate Mast Cells?

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

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

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

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

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

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

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

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

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

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

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

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

 

flu tox get help you need banner click lisa