EMA Final Decision re Fluoroquinolones

The European Medicines Agency (EMA) released their final decision regarding fluoroquinolones. You can read the EMA verdict in “Quinolone- and fluoroquinolone-containing medicinal products” and “Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics” (both from the EMA web site). Additional information can be found on the UK Government web site in the article, “Fluoroquinolone antibiotics: new restrictions and precautions for use due to very rare reports of disabling and potentially long-lasting or irreversible side effects.” Changes to European fluoroquinolone labels can be viewed HERE.

From the EMA:

Restrictions on the use of fluoroquinolone antibiotics will mean that they should not be used:

  • to treat infections that might get better without treatment or are not severe (such as throat infections);
  • to treat non-bacterial infections, e.g. non-bacterial (chronic) prostatitis;
  • for preventing traveller’s diarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder);
  • to treat mild or moderate bacterial infections unless other antibacterial medicines commonly recommended for these infections cannot be used.

Importantly, fluoroquinolones should generally be avoided in patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic. They should be used with special caution in the elderly, patients with kidney disease and those who have had an organ transplantation because these patients are at a higher risk of tendon injury. Since the use of a corticosteroid with a fluoroquinolone also increases this risk, combined use of these medicines should be avoided.

Please excuse me for not knowing exactly how European drug regulation works (and please correct me if I am wrong), but it looks like the EMA makes recommendations, then the various European governments pass down instructions to their citizens.

The UK government web site gave the following recommendations to healthcare providers:

Advice for healthcare professionals:

  • systemic (by mouth, injection, or inhalation) fluoroquinolones can very rarely cause long-lasting (up to months or years), disabling, and potentially irreversible side effects, sometimes affecting multiple systems, organ classes, and senses
  • advise patients to stop treatment at the first signs of a serious adverse reaction, such as tendinitis or tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy, and central nervous system effects, and to contact their doctor immediately for further advice – sheet for patients

do not prescribe fluoroquinolones:

  • for non-severe or self-limiting infections, or non-bacterial conditions

  • for some mild to moderate infections (such as in acute exacerbation of chronic bronchitis and chronic obstructive pulmonary disease; please refer to revised indications in the Summary of Product Characteristics) unless other antibiotics that are commonly recommended for these infections are considered inappropriate (see below)

  • ciprofloxacin or levofloxacin should no longer be prescribed for uncomplicated cystitis unless other antibiotics that are commonly recommended are considered inappropriate (see below)avoid use in patients who have previously had serious adverse reactions with a quinolone or fluoroquinolone antibiotic

  • prescribe with special caution for people older than 60 years and for those with renal impairment or solid-organ transplants because they are at a higher risk of tendon injury avoid use of a corticosteroid with a fluoroquinolone since co-administration could exacerbate fluoroquinolone-induced tendinitis and tendon rupture

  • report suspected adverse drug reactions to fluoroquinolone antibiotics on the Yellow Card website or via the Yellow Card app (download it from the Apple App Store, or Google Play Store)

I hate that they put “very rarely” into these warnings, seeing as adverse reactions to fluoroquinolones are woefully under-studied and the assertion that these effects are “rare” is based on assumption rather than fact. BUT, these prescriber guidelines, along with the EMA guidelines, are steps in the right direction, and hopefully they will cut unnecessary fluoroquinolone prescriptions significantly.

Here are a few notes about the proposed changes to the European Fluoroquinolone Warning Labels:

  1. It is recommended that fluoroquinolone use be restricted for uncomplicated cystitis, Acute exacerbation of chronic bronchitis and of chronic obstructive pulmonary disease, Acute bacterial rhinosinusitis, and Otitis media acute.
  2. The warning labels are still leaving a lot of discretion to doctors/prescribers, and state, “In [indication] [name of product] should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.” even though other parts of the warning label note that FQs should not be used for that particular indication. I worry that this may lead to some confusion among doctors/prescribers.
  3. The new warning label notes that people who have experienced adverse reactions to fluoroquinolones in the past should not take fluoroquinolones. “The use of [INN] should be avoided in patients who have experienced serious adverse reactions in the past when using quinolone or fluoroquinolone containing products (see section 4.8). Treatment of these patients with [INN] should only be initiated in the absence of alternative treatment options and after careful benefit/risk assessment.”
  4. The possibility of prolonged, serious, and disabling side effects of fluoroquinolones are noted. “Prolonged, disabling and potentially irreversible serious adverse drug reactions
    Very rare cases of prolonged (continuing months or years), disabling and potentially
    irreversible serious adverse drug reactions affecting different, sometimes multiple, body
    systems (musculoskeletal, nervous, psychiatric and senses) have been reported in patients
    receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk
    factors. [INN] should be discontinued immediately at the first signs or symptoms of any
    serious adverse reaction and patients should be advised to contact their prescriber for
    advice.”
  5. I’m slightly shocked that the risk of tendon problems is just-now being added to European warning labels, but it is one of the changes noted. “Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment. The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ transplants, and those treated concurrently with corticosteroids. Therefore, concomitant use of corticosteroids should be avoided. At the first sign of tendinitis (e.g. painful swelling, inflammation) the treatment with [INN] should be discontinued and alternative treatment should be considered. The affected limb(s) should be appropriately treated (e.g. immobilisation). Corticosteroids should not be used if signs of tendinopathy occur.”
  6. Warnings about peripheral neuropathy are also added. “Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypaesthesia, dysesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones. Patients under treatment with [INN] should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop in order to prevent the development of potentially irreversible condition.”
  7. Permanently disabling effects are noted again, “*Very rare cases of prolonged (up to months or years), disabling and potentially irreversible serious drug reactions affecting several, sometimes multiple, system organ classes and senses (including reactions such as tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impairment of hearing, vision, taste and smell) have been reported in association with the use of quinolones and fluoroquinolones in some cases irrespective of pre-existing risk factors.”
  8. Disappointingly, the “Package leaflet: Information for the patient” is full of the words “very rarely” when referring to all the potential effects of fluoroquinolones. Again, the exact rate of adverse reactions to fluoroquinolones is unknown (and may be unknowable because of delayed adverse reactions), and I think that it’s a dis-service to patients to downplay the possibility of these serious and severe effects of fluoroquinolones.

THANK YOU, THANK YOU, THANK YOU to all the European advocates that pushed for these changes in fluoroquinolone warnings and prescribing. You have made an enormous difference, and hopefully rates of fluoroquinolone prescriptions will decrease significantly because of your advocacy.

*****

Levofloxacin and Azithromycin Both Cause Heart Rhythm Abnormalities

The CBS News article, “FDA warns azithromycin “Z-pack” antibiotics could lead to deadly heart rhythms for some” has been circulating around Facebook lately. The article is from 2013, but it is still relevant today, and I am glad to see that people are spreading the word about the dangers and consequences of all antibiotics.

However, whenever I see the article posted, I want to scream – Levaquin/levofloxacin is just as bad, if not worse, for heart health, than azithromycin/Z-packs. 

The article in Annals of Family Medicine, “Azithromycin and Levofloxacin Use and Increased Risk of Cardiac Arrhythmia and Death” concluded that:

“Compared with amoxicillin, azithromycin resulted in a statistically significant increase in mortality and arrhythmia risks on days 1 to 5, but not 6 to 10. Levofloxacin, which was predominantly dispensed for a minimum of 10 days, resulted in an increased risk throughout the 10-day period.”

The article elaborates:

“In this nationwide cohort study of US veterans, compared with amoxicillin, we found that a short-course of azithromycin therapy was associated with statistically significant hazard ratios of 1.47 for mortality risks and 1.77 serious arrhythmias risks within the first 5 days of treatment. The risk of these events was not significantly increased for days 6 to 10. Treatment with levofloxacin, also when compared with amoxicillin, had statistically significant hazard ratios of 2.49 for mortality risk and 2.43 for serious arrhythmia risk; however, the increased risk with levofloxacin continued to be statistically significant during days 6 to 10.”

Both azithromycin/Z-packs and Levofloxacin are more dangerous than amoxicillin. But Levofloxacin is more dangerous to the heart for a longer period of time.

The warning label for fluoroquinolones elaborate on the arrhythmia risk:

“Some fluoroquinolones, including LEVAQUIN®, have been associated with prolongation of the QT interval on the electrocardiogram and infrequent cases of arrhythmia. Rare cases of torsade de pointes have been spontaneously reported during postmarketing surveillance in patients receiving fluoroquinolones, including LEVAQUIN® . LEVAQUIN® should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving Class IA (quinidine, procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval.”

Additionally, fluoroquinolones increase the risk of aortic ruptures and tears. The FDA added warnings about aortic tears and ruptures to fluoroquinolone warning labels in 2018 – “FDA warns about increased risk of ruptures or tears in the aorta blood vessel with fluoroquinolone antibiotics in certain patients.”

People should be aware of the increased risk of heart rhythm irregularities with azithromycin/Z-packs. They should know that azithromycin prescriptions can have deadly consequences. People should also know that fluoroquinolones, Levofloxacin in particular, is NOT a safer alternative. In fact, it’s even more dangerous than azithromycin, and it not only causes deadly heart-rhythm irregularities, it also damages blood vessels.

People with pre-existing heart-rhythm irregularities should avoid both azithromycin and levofloxacin (as well as the other fluoroquinolones).

Doctors and patients alike should be aware of these risks to heart and vascular health that are associated with antibiotic use. A decade ago it would have been considered unthinkable that antibiotics could be linked to heart and vascular problems. But the research has shown that these connections exist.

Be careful, my friends. And spread the word about all dangerous antibiotics.

*****

Floxie Hope Podcast Episodes 27 & 28 – Dawn

Dawn shares her journey through fluoroquinolone toxicity on episodes 27 and 28 of The Floxie Hope Podcast. Please listen to, and share, these podcasts:

http://www.floxiehopepodcast.com/episode-027-dawn/

http://www.floxiehopepodcast.com/episode-028-dawn-2/

Both podcasts can be downloaded through iTunes as well: https://itunes.apple.com/us/podcast/floxie-hope-podcast/id945226010

Dawn suffered from severe depression, suicidal ideation, and dark thoughts that made her fear for her life. I hope that her story helps others who are going through this to know that they are not alone.

A couple of compounding issues that Dawn had were benzodiazepine withdrawal and breast implant illness. If anyone is suffering from those issues too, Dawn’s story will likely resonate with them too.

Please accept my apologies for both splitting Dawn’s story into two podcast episodes, and for the poor sound quality. My computer that I knew how to produce podcasts on died, and I’m having some issues with my new computer. Thank you for your patience, and for listening to Dawn’s episodes of the podcast despite the poor production quality.

*****

Fluoroquinolone Toxicity News in South Africa – Carte Blanche

I encourage you all to watch, and share, the WONDERFUL news story from Carte Blanche, a South African investigative journalism television series, about the dangers of fluoroquinolones. It’s one of the best pieces of journalism I have seen regarding fluoroquinolone adverse-effects. You can view the story through the Carte Blanche web site, or through Youtube:

Carte Blanche Web Site, “Antibiotic Alert”

Youtube Link

Carte Blanche tells the stories of pain brought on by fluoroquinolones for three South African “floxies,” Tracy Witelson, Gerald Ludwinsky, and Debbi Kinrade. Their stories are powerful and poignant, and they thoroughly describe the horror of fluoroquinolone toxicity.

The Carte Blanche journalist that interviews the victims of fluoroquinolones, as well as Bayer representatives and representatives of the South African Health Products Regulatory Authority (SAHPRA), does a WONDERFUL job of compassionately framing the stories of the victims, and pushing the pharmaceutical and SAHPRA representatives by asking them tough questions, challenging them, and doing what he can to hold them accountable for the harm done by fluoroquinolones.

In an exchange that is simply wonderful, journalist Derek Watts goes over the newly (2016-2018) highlighted warnings included on the FDA warning labels for fluoroquinolones (including a warning that notes that fluoroquinolones can cause permanent disability, one that notes that the risks of fluoroquinolone use outweigh the benefits, one that notes that fluoroquinolones cause blood-sugar irregularities and mental health adverse-effects, and one that notes that fluoroquinolones increase the risk of aortic aneurysm and dissection) with Dr. Naren Jairam, the Bayer Pharmaceuticals representative. Dr. Jairam dismissively asserts that these warnings are nothing new. Watts responds by asking Jairam why Bayer hasn’t been communicating the dangers of fluoroquinolones with doctors (much less patients). Jairam claims that Bayer supports responsible use of antibiotics and that Bayer has advocated that fluoroquinolones not be used as first-line antibiotics. Watts CALLS HIM OUT and says, “That’s not true,” and notes that millions of prescriptions for non-life-threatening infections are being given all over the world. It is truly wonderful to see a quick-witted journalist asking tough questions of pharmaceutical company representatives, and calling them out when they lie and mislead.

In another exchange, Watts asks Jairam, “Is your intention to obfuscate or clarify?” VERY good question – thank you for having the chutzpah to ask, Mr. Watts!

Watts also confronts Eric Chauke, Bayer’s Head of Regulatory Affairs, by asking him to show that Bayer is communicating the risk of harm by fluoroquinolones with doctors. Chauke shows Watts some general pamphlets on antibiotic stewardship, and Watts pushes back – noting that there is nothing in what Chauke is showing him that adequately communicates that fluoroquinolones can have “dreadful side-effects” or that adequately communicates that fluoroquinolones should not be used as first-line antibiotics.

Watts also asks Professor Marc Blockman, a representative of the South African Health Products Regulatory Authority (SAHPRA), some tough questions. He asks whether or not the SAHPRA warnings are adequate, and why SAHPRA can’t send a communication to doctors stating, “don’t prescribe these drugs unless it’s life threatening and there is no alternative?” Patient advocates have been asking the same thing for years, and it’s nice to hear a journalist ask this question to a drug regulator.

I love how tough Watts is on the Bayer and SAHPRA representatives. He is doing a wonderful job at being a journalist that brings to light stories of victims, and holding those in-power responsible for their role in victimizing people.

Please watch and share the Carte Blanche piece on fluoroquinolones. It’s wonderful, and it would be great for it to be internationally “viral.”

*****

 

The Term “Flox”

When I tell people about this site they often ask me what the terms flox, floxed, and floxie mean. I am not a lexicographer by any stretch, and these are not official definitions, but here are my answers:

Flox (noun): A shorthand term for the multi-symptom, chronic illnesses brought on by fluoroquinolone antibiotics that are referred to as Fluoroquinolone toxicity or Fluoroquinolone Associated Disability (FQAD).

Flox (verb): To be afflicted with fluoroquinolone toxicity or FQAD. The term “flox” is typically used in the past tense as “floxed,” as in, “I was floxed by cipro in 2011.”

Floxie (noun): A person who suffers from fluoroquinolone toxicity or FQAD.

The term “flox” comes from the names of the fluroquinolone antibiotics. All the fluoroquinolones contain “flox” in their names – ciproFLOXacin, levoFLOXacin, moxiFLOXacin, gatiFLOXacin, oFLOXacin, etc. As communities of victims of these drugs formed, people found it easier to say, “I’ve been floxed” or, “I’m a floxie” than to say, “I am going though a multi-symptom illness brought on by fluoroquinolone antibiotics.” Perhaps the term “FQAD” would have been just as easy to say as “flox,” but “flox” preceded “FQAD” by more than a decade and the term has stuck.

The earliest written record of the term “flox” that I can find is in Stephen Fried’s 1998 bestselling book, “Bitter Pills: Inside the Hazardous World of Legal Drugs.” In it, Fried describes his wife’s severe, primarily psychiatric, adverse reaction to ofloxacin, a fluoroquinolone antibiotic. Fried noted that the community of people who had been hurt by this class of drugs referred to themselves as “floxies” and spoke of their condition as being “floxed.” (EDIT/NOTE – Please see Mr. Fried’s comment below for correct information about the early usage of the term “flox.)

Most journal, and even news, articles don’t use the terms “flox” or “floxie.” They typically refer to the constellation of symptoms that “floxies” deal with as “adverse reactions to fluoroquinolone antibiotics” or they don’t refer to the syndrome as a whole at all, rather, they’ll list the symptoms that their featured victim suffers from, and then note that the victim attributes those symptoms to fluoroquinolone antibiotics. A couple news articles have used the term FQAD, as it was coined by the FDA, and is seen as a bit more official than “flox.”

In online communities new terms are often coined, and they gain traction in those communities. “Flox” is one of those terms. The terms “flox” and “floxie” are primarily used on the internet in support groups for victims of fluoroquinolones. The biggest Facebook group for victims of fluoroquinolones is The Fluoroquinolone Toxicity Group, and their url is https://www.facebook.com/groups/floxies/ (note the “floxies” in the url – it’s easier than https://www.facebook.com/groups/FluoroquinoloneToxicityGroup). Additionally, this site is one of the more popular blogs about fluoroquinolones, and it’s called Floxie Hope. The terms “flox” and “floxie” are used throughout blogs and support groups dedicated to fluoroquinolone toxicity.

People within the “floxie” groups and communities know these terms and what they mean and imply. The people in the “floxie” community know when someone says that they are “severely floxed” that it means that person is suffering from more symptoms than they can count or name and that they are likely bed or house bound as a result of their fluoroquinolone-induced injuries. Of course, everyone’s experience is different, and people are encouraged in these communities to further describe their pain and their experience, but it’s far easier to say, “I’m severely floxed” than it is to list dozens of symptoms then say that those symptoms were caused by fluoroquinolone antibiotics.

Some people really hate the terms “flox” and they particularly hate the term “floxie.” They see the terms as silly and flippant, and they see it as disrespectful to those who are suffering from fluoroquinolone toxicity. Fluoroquinolone toxicity IS a serious and severe illness, and it should be taken seriously by doctors, patients, regulators, and everyone else. It is not a joke, or something to be taken lightly. It is a life-altering, often disabling, syndrome. Fluoroquinolones have maimed and killed people, and fluoroquinolone toxicity should be taken as seriously as other multi-symptom, chronic, mysterious illnesses like M.S., Lupus, Lyme Disease, M.E./CFS, etc.

Neither “flox” nor “floxie” are particularly serious terms, and I empathize, and even agree with, those who see it as minimizing the seriousness and severity of fluoroquinolone toxicity.

But… sometimes terms just stick. Both flox and floxie are terms that have resonated with people in the community, and they have stuck. Many people find it easier to describe their illness as being “floxed” than to describe it any other way. It resonates with people more to say, “floxies unite!” than it does to say, “victims of fluoroquinolone antibiotics come together!” For the purposes that the the terms are used, they work well for expressing what people want and need to say. I don’t think that anyone who uses the terms “flox” or “floxie” mean any disrespect to the illness or the people suffering from it. In fact, most of the people using the terms are either victims of fluoroquinolones or those who love a victim of fluoroquinolones.

I am writing this post on a site called Floxie Hope, so I am, of course, somewhat biased. I like the term “floxie” and it has become part of my brand (if you can say that a blog has a brand). I think that the term sticks in people’s minds and it resonates with them. There is an understanding of what it means–at least within our community. The naming of this site was somewhat accidental–I was trying to figure out how to create a web site and this was supposed to be my place-holder site until I figured out the mechanics of blogging, then I was supposed to think of a more well thought out name for the official site, but then this site got rolling while named Floxie Hope, and 5.5 years later, it’s still going and here we are.

I hear the people who think that “flox” and “floxie” aren’t serious enough terms to connote the severity of fluoroquinolone toxicity. In a lot of ways, I think they’re right. BUT, I don’t think that the term has held this community back. We have made a lot of progress over the last decade. We still have a lot of work to do, but millions of people have become aware of fluoroquinolone toxicity and fluoroquinolone dangers over the last decade, and part of the momentum of this community is our shared language and our shared understanding of terms like “flox.”

The terms “flox” and “floxie” are ingrained in our community, and they are likely here to stay as long as fluoroquinolones are hurting people (I hope for the extinction of the term through the strict limiting of the drugs – but we’re a long way from that and it’s certainly a matter for another post). I think that the terms are doing more good (through ease of communication, bringing people together, and having terms that resonate with many) than harm.

I am hopeful that the terms “flox” and “floxie” will someday be so well understood and accepted that they make it into the dictionary. The only criteria for words making it into the dictionary is that they appear in edited text, so I actually hope that more journalists start using the terms “flox” and “floxie” in their articles. Having the terms “flox” and “floxie” in the dictionary would be wonderfully validating, and it would help to increase awareness of fluoroquinolone toxicity.

When I describe this site, I often try to tell the back-story and give the long explanation of how I was hurt by ciprofloxacin. Sometimes the person who I’m talking to says something like, “Oh, you’ve been floxed – that happened to my sister-in-law.” The word is getting out, and the terms “flox” and “floxie” are spreading. It’s a good thing. Awareness is one of the most important steps toward change, and short, easy-to-remember terms like “flox” and “floxie” help people to become aware of the dangers of fluoroquinolones.

*****

NY Resolution to Heal My Gut

Seven years after I got floxed, and 5.5 years since I wrote my recovery story, I am still doing well. I am working at a job that I enjoy, I am in a good relationship, I can hike, bike, swim, and otherwise move my body, I have my reading comprehension and intellect back, my energy level is decent, and my autonomic nervous system generally operates as it’s supposed to. I feel good, and I’m living a good life. As I’ve said many times before, I hope that my recovery gives you hope for your healing.

With it noted that I’m generally healed, and that I feel good in most areas of my life, I’m going to confess that…

My gut is a mess, and I am worried about it.

I have no idea whether my gut issues are from being floxed or not. GI tract problems weren’t part of my initial floxing–I didn’t have any gut issues until recently. But in the last year(ish), my gut has started to have… issues. Unfortunately, there is no way to describe GI issues without describing bowel movements, so here goes – I haven’t had a normal textured poo in ages. It has been at least a year. TMI? Sorry.

Poorly formed stools are definitely a sign of inflammation and other gut issues, and, despite the fact that I feel generally okay, I’m concerned about my gut health.

I want a gut that doesn’t hurt every day, that forms healthy-textured poos, and that I don’t worry about. I don’t want to be concerned that I’m developing IBS, or crohn’s disease, or that I have c-diff, or anything else. I’m guessing that I don’t have any of those things, and that I just have an inflamed gut, but I don’t want that either. I want a healthy, happy, healed gut that feels good and operates entirely normally. I don’t think that’s too much to ask for. I also think that my gut is my responsibility, and that no one other than me can do anything about MY gut health.

It’s December 28th as I write this, and the beginning of the new year seems as good a time as any to commit to healing my gut. Here are some of the things I plan to do to heal my gut in 2019 (public accountability is good, right?):

Clean up my diet

When I first got floxed I ate only meat and veggies. I was scared of most foods, and I ended up losing weight and feeling worn-down because I wasn’t ingesting enough calories. After I got over the fear of food, I added fruits and other good things to my diet, and ended up eating as outlined in The Floxie Food Guide. But, after a while of feeling better, I stopped restricting my diet entirely. I didn’t eat much processed food because I’ve never liked processed food, but I ate whatever I wanted. Perhaps my GI issues are the result of my “anything goes” diet (or maybe my GI issues stem from something else like mold in my house or fluoride in my city’s water or a parasite – it’s hard to tell). Anyhow, it’s time to restrict my diet again with the hope of calming the inflammation in my intestines.

Step 1: Give up gluten. My husband has been on a bread-baking kick lately, so this will take some willpower, but it has helped so many people, and it seems like a logical first step, so, I’m going to go gluten-free and see if that helps.

Step 2: Give up legumes. I like beans, but they make me feel like crap.

Step 3: Limit dairy. I love dairy too much to say that I’m going to give it up, but I’m going to try to be cognizant of how much I eat and how it makes me feel and limit it.

I want to be able to sustain these changes, so these are the only things I’m going to do at first. If they don’t work, I’ll move on to a more restricted protocol – probably something close to The Wahls Protocol because it has helped so many fellow “floxies.”

I’ve noticed that oatmeal makes me feel better generally, so I’m going to eat more oatmeal. I’ve also noticed that spicy food tends to make me feel worse, so I’m going to limit them even though many spices are supposed to be anti-inflammatory.

Cut the coffee and alcohol

This is a no-brainer, right? No explanation is necessary as to why these need to go in order for me to heal my gut. It’s hard though, so, here’s my public accountability.

Note that the coffee I drink is decaf. I haven’t been able to tolerate caffeinated coffee post-flox.

I really like both coffee and alcohol, and this is going to be tough. I’m only committing to cutting down on them, not to completely giving up either, but I can commit to cutting the coffee by 50% and the alcohol by 80%.

Eat probiotic foods

Sauerkraut and kimchi, here I come. Luckily, I like both.

Meditate, breathing exercises, eat mindfully, and otherwise stimulate the vagus nerve to heal the gut

Our guts are connected to our brains via the vagus nerve, and stimulating and toning the vagus nerve through meditating, breathing exercises, mindfulness, and other activities, can heal both the gut and the brain.

Here is an interesting post about how a guy healed his IBS through stimulating his vagus nerve through gargling: How I Cured My Irritable Bowel Syndrome.

As I was going through the early stages of my fluoroquinolone toxicity journey I was really good about meditating, doing breathing exercises, going to the chiropractor and/or acupuncturist, and doing other things that stimulated my vagus nerve. I think that these things helped me to heal. They were part of my healing journey, and I recommend them to others because they are healing for the body, mind, and spirit, and because they stimulate the vagus nerve and trigger the release of acetylcholine. Like watching my diet, conscientiously doing activities that stimulated my vagus nerve fell to the wayside as I healed. I felt good, so I didn’t need to do breathing exercises to feel better. But, I think that all the vagus nerve healing exercises were helpful for my gut when I was doing them, and that they’ll be helpful for my gut if I do them again.

Shoot, I wrote a book about healing the vagus nerve – I should make the time to practice what I preach.

Step 1: Meditate daily

Step 2: Swim weekly – it forces breathing exercises, and movement is good for the vagus nerve.

Step 3: Eat mindfully

Step 4: Gargle and/or hum daily

 

Those are my resolutions, and I hope that they result in a happier, healthier gut.

I’m open to suggestions for gut healing. Please feel free to comment below to let me know what has helped you to heal your gut. As you may gather from the post above, I am not willing to go on a super-restrictive diet unless/until all else fails, but I am willing to hear suggestions. I’m also open to trying supplements that heal the gut including aloe juice, collagen, bone broth, probiotic supplements, etc. If you have any recommendations based on personal experience with gut-healing supplements, please comment below.

Whenever someone asks in the forums about how to heal from fluoroquinolone toxicity, someone always answers, “heal your gut.” They’re right, of course–but it’s easier said than done. There are people in the “floxie” community who are much more better about having a “clean” diet than I am who still struggle with GI issues and other symptoms of fluoroquinolone toxicity. I’m hopeful that my modified “clean-ish” diet will help my gut to heal, and that the other things mentioned above help too. I want to acknowledge though, that “healing the gut” is not simple and that there isn’t a single answer for how to do it. I’m hopeful that the steps noted above will help me, and that I’ll have a healthier, happier gut in 2019 than I did in 2018.

*****

 

 

 

 

FDA Warns About Increased Risk of Aortic Aneurysm and Dissection with Fluoroquinolone Antibiotics

On December 20, 2018, the US FDA released a review that “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.” (source)

This acknowledgement from the FDA came three years after two major studies showed a statistically significant increase in risk of aortic dissection and aneurysm with fluoroquinolone use. The studies, “Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone” (JAMA Internal Medicine, 2015), and “Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study” (BMJ Open, 2015) both found that fluoroquinolone use is associated with an increased risk of aortic aneurysm and dissection, with “Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone” concluding that:

“Use of fluoroquinolones was associated with an increased risk of aortic aneurysm and dissection. While these were rare events, physicians should be aware of this possible drug safety risk associated with fluoroquinolone therapy.”

Both “Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone” and “Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study” are major studies, with “analysis of 1477 case patients and 147 700 matched control cases from Taiwan’s National Health Insurance Research Database (NHIRD) from among 1 million individuals longitudinally observed from January 2000 through December 2011” for the former, and 1.7 million older adults in Ontario, Canada, for the later. They are robust studies that show a statistically significant association between fluoroquinolone-use and aortic aneurysm and dissection.

The FDA took too long to warn the public about the dangers of aortic aneurysm and dissection post exposure to fluoroquinolones, but, better late than never. Here is the full text of the FDA announcement that was published on Thursday December 20, 2018:

[12-20-2018] A U.S. Food and Drug Administration (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.

Fluoroquinolones should not be used in patients at increased risk unless there are no other treatment options available.  People at increased risk include those with a history of blockages or aneurysms (abnormal bulges) of the aorta or other blood vessels, high blood pressure, certain genetic disorders that involve blood vessel changes, and the elderly.  We are requiring that a new warning about this risk be added to the prescribing information and patient Medication Guide for all fluoroquinolones.

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).

Health care 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.  Before starting an antibiotic prescription, inform your health care professional 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.  If you have been prescribed a fluoroquinolone to treat an infection, do not stop the antibiotic without first talking to your health care professional.

We reviewed cases reported to FDA* and four published observational studies1,2,3,4 that showed an increased risk of aortic aneurysm or dissection associated with fluoroquinolone use (see Data Summary).  How some of the studies were designed or carried out, and the ways the data were analyzed could affect the study findings; however, taken together, the results of all four studies provide consistent evidence of an association between fluoroquinolone use and aortic aneurysm or dissection.  The underlying mechanism for this risk cannot be determined from these studies, and the background risk of aortic aneurysm can vary depending on the population.  The background risk has been estimated from nine aortic aneurysm events per 100,000 people per year in the general population to 300 aortic aneurysm events per 100,000 people per year in individuals at highest risk.  Because multiple studies showed higher rates of about twice the risk of aortic aneurysm rupture and dissection in those taking fluoroquinolones, FDA determined the warnings were warranted to alert health care professionals and patients.

We communicated safety information associated with fluoroquinolones in July 2018 (significant decreases in blood sugar and certain mental health side effects), July 2016 (disabling side effects of the tendons, muscles, joints, nerves, and central nervous system), May 2016 (restricting use for certain uncomplicated infections), August 2013 (peripheral neuropathy), and July 2008 (tendinitis and tendon rupture).

To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving fluoroquinolones or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

More information about the link between fluoroquinolones and aortic aneurysm and dissection can be found in these studies or articles:

  1. JAMA Internal Medicine, “Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone
  2. BMJ Open, “Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study
  3. BMJ, “Fluoroquinolone use and risk of aortic aneurysm and dissection: nationwide cohort study
  4. Baylor College of Medicine, “Ciprofloxacin increases risk of tears, rupture in mouse aortas

Additionally, here are some news articles about the FDA acknowledgement of the link between fluoroquinolones and aortic aneurysm and dissection:

  1. CNN, “Certain antibiotics may cause aortic aneurysm, FDA warns
  2. NBC News, “FDA warns some antibiotics can cause fatal heart damage: Drugs commonly used to treat upper respiratory infection, urinary tract infections should not be prescribed to patients already at risk
  3. Medscape, “More Fluoroquinolone Safety Concerns
  4. WRIC ABC 8 Richmond, “Commonly prescribed antibiotics can cause potentially deadly ruptures, FDA warns