Tag Archives: adverse reactions

The Bleeding Edge and Parallels with Fluoroquinolone Toxicity

Have you seen the documentary The Bleeding Edge? It’s a wonderful film about the hazards of medical devices that I highly recommend. It’s currently (August 2018) available on Netflix. If you haven’t seen it, please do. It is an eye-opening, thought-provoking, insightful, frightening film.

The Bleeding Edge features stories from people who have suffered adverse reactions to various medical devises and procedures. Victims of Essure, mesh implants, metal hip replacements, and robotic surgical procedures report the harm done to them by these devices and procedures in the film.

The Bleeding Edge is a stark and scary reminder that, unfortunately, too often doctors are not abiding by the Hippocratic Oath. “First, do no harm” has gone by the wayside as these products and procedures maim their victims. Compounding the tragedy of the harm caused by these devices or procedures is the fact that, in many cases, there are safer devices or procedures available that would have had the intended results that the patients (and presumably their physicians) sought. Tying a woman’s tubes is a safer method of permanent sterilization than Essure; ceramic hip replacements are safer than metal ones; physical therapy can strengthen the pelvic floor and relieve symptoms of incontinence as well as mesh can; and, a surgeon’s hand may be a safer tool than a robotic arm. However, these safer procedures were not performed on the victims featured, or on thousands of other people, because the entire medical system ignored their Hippocratic Oath. Doctors (or administrators or insurance companies) were swayed to use these newer less-safe methods by marketing, efficiency, money, or ignorance–and patients were hurt in the process. It’s not okay, and steps back toward the basis of medicine in the Hippocratic Oath are, sadly, necessary.

There are several parallels between the experiences of people hurt by fluoroquinolone antibiotics (i.e. “floxies”) and the people featured in The Bleeding Edge. The adverse reactions to Essure are particularly similar to adverse reactions to fluoroquinolones. Adverse reactions to Essure look, and seem to feel, an awful lot like autoimmune diseases. Likewise, fluoroquinolone toxicity looks and feels a lot like an autoimmune disease. Essure adverse reactions are often severe and they affect multiple bodily functions. The women who had adverse reactions to Essure often suffered from permanent disability, even after the metal springs were removed from their body. Likewise, even long after fluoroquinolones “should” be out of a person’s body, the effects remain. Unfortunately, both Essure and fluoroquinolone adverse reactions can be permanent.

Like those featured in The Bleeding Edge who suffered from the toxic effects of metal-on-metal hip implants, fluoroquinolone victims often experience psychiatric adverse reactions. Fluoroquinolones can induce many serious mental health symptoms, and the FDA recently added “disturbances in attention, disorientation, agitation, nervousness, memory impairment, and serious disturbances in mental abilities called delirium” as highlighted adverse reactions to fluoroquinolones. Fluoroquinolones can also induce psychosis. The patient featured in The Bleeding Edge that suffered from psychosis, tremors, and other serious mental adverse effects from a metal hip replacement, is an Orthopedic Surgeon himself, and he “said he would never have believed neurological problems could come from orthopedic devices, if it wasn’t for that experience, and now tests the cobalt levels of his patients if they complain of having Parkinson’s or dementia-like symptoms.” (source). The victims of metal hip replacements are often told that their symptoms are simply a result of getting older. Fluoroquinolones are given to people of all ages, but those who are over 30 are often told that their symptoms are from “getting old” not from the drugs.

None of the adverse reactions featured in The Bleeding Edge are what one would intuitively expect an adverse reaction to look like. Who would think that a type of hip replacement could lead to psychosis? Who would think that a sterilization procedure could lead to a permanent autoimmune/neuroimmune disease? Similarly, who would think that a commonly prescribed class of antibiotics could cause multi-symptom, chronic, illness that has a lot in-common with these illnesses brought on by medical device adverse reactions? It’s absurd and unbelievable. It’s true though. Adverse reactions don’t look like they are “supposed” to look. They aren’t intuitive and they aren’t easy to identify.

Hopefully The Bleeding Edge will reform how patients and doctors alike view medical device safety. I hope that it also reforms how people think about adverse reactions generally, and that recognition of the connections between adverse drug and device reactions and multi-symptom, chronic, “mysterious” diseases starts to enter mainstream consciousness.

Watch The Bleeding Edge. It is a great film that has a message that needs to be heard.

Sorry, I don’t know how to squeeze this in gracefully, but several of the victims featured in the film had their intestines fall out of their bodies post-hysterectomy via robotic surgery. Is that not one of the most horrifying things imaginable–to have your intestines fall out of your body? Aaaaaaagh!!! Floxies can at least be thankful that our organs generally stay inside our bodies.

Mitigating Fluoroquinolone Damage

What if a loved one must take a fluoroquinolone because it is the only option available to save their life? How do they avoid getting “floxed” and experiencing the devastation that fluoroquinolones have brought to too many lives?

Undeniably, there is a range of reactions to fluoroquinolones – from people not reacting badly at all, to people being permanently disabled and in excruciating pain, and everything in between. If a loved one must take a fluoroquinolone because it is the only viable option, is there any way to push them toward the “not hurt” end of the spectrum?

Who Gets Floxed?

At this time, no one knows what makes someone susceptible to getting “floxed.” No one knows why some people tolerate fluoroquionlones well but other people don’t. No one knows why an individual can tolerate fluoroquinolones fine at one time, but have a horrible reaction another time. No one knows what genetic predispositions contribute to some people getting hurt by fluoroquionlones.

The epidemiologists say that the risk of fluoroquinolone-induced tendon ruptures is higher in those over the age of 60. However, there are many “floxies” under the age of 60, and many of them suffer from tendon ruptures and other musculoskeletal problems.

It is hypothesized in, “Fluoroquinolone Antibiotics and Thyroid Problems: Is there a Connection?” that, “anyone with any underlying genetic predisposition, or possibly harboring a subclinical, latent, or silent endocrinopathy might be ‘pushed over the edge’ into full blown clinical pathology” by fluoroquinolones. But I have a friend who is over the age of 60 and who has thyroid problems, as well as osteoporosis, who recently took a course of Cipro and was fine afterward. I saw her yesterday and she is doing well. I would have thought that she would have been predisposed toward an adverse reaction… but she wasn’t.

As a strong and athletic 32 year old who had no history of illness, I certainly didn’t think that I was predisposed to having an adverse reaction to Cipro, but it happened. Cipro made me sick for a while.

There seems to be a certain amount of “Russian Roulette” going on when one takes a fluoroquinolone. There aren’t any tests to determine who will react poorly to fluoroquinolones, and even known risk factors only sometimes make a difference. Some people seem to get lucky, while others get very, very unlucky. I realize that attributing adverse reactions to bad luck and “Russian Roulette” is a frustrating non-answer, but, unfortunately, that’s where we’re at right now – the land of frustrating non-answers. Welcome to being a floxie.

Despite the seeming randomness of adverse reactions, there is sufficient evidence that people who are over the age of 60, athletes, those who have a history of psychiatric illness, those with a history of benzodiazepine withdrawal, people who regularly use NSAIDs, people using corticosteroids, people who have an existing autoimmune or endocrine disorders, those who are immunocompromised, and people who have a mitochondrial disorder (in any of its manifestations, including ME/CFS and fibromyalgia) should avoid fluoroquinolones if at all possible. (More about this can be found in the post, “Don’t Take Cipro, Levaquin or Avelox If….” on Hormones Matter.)

When it’s the Only Option

Given that few people think that an adverse drug reaction will happen to them, and that antibiotic resistance is reducing the number of safe antibiotics available to treat many infections, many people are stuck with fluoroquinolones being the only option available to them.

If this is the situation for you (yes, I do realize that many/most floxies would rather die than take a fluoroquinolone again, but that’s not the case for everyone) or a loved one, is there anything that can be done to mitigate the damage done by the drug?

Maybe.

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Mitigating Fluoroquinolone Damage

Studies have noted that magnesium and vitamin E can mitigate some of the damage done by fluoroquinolones. In, Musculoskeletal Complications of Fluoroquinolones: Guidelines and Precautions for Usage in the Athletic Population, it is noted that:

“Pfister et al [25] studied the effects of oral vitamin E (tocopherol) and magnesium supplementation on ciprofloxacin-associated chondrotoxicity. Juvenile rats were divided into 4 groups: those fed a normal diet, a vitamin E– enriched diet, a magnesium-enriched diet, or a diet enriched with both vitamin E and magnesium. These diets were initiated 10 days before the rats were given ciprofloxacin. Two days after fluoroquinolone exposure, cartilage samples from the knee joints were histologically examined, and cartilage and plasma concentrations of magnesium, calcium, and vitamin E were measured. Fluoroquinolone-associated cartilage changes were observed in all groups, but the supplemented groups showed significantly less change, with the magnesium and vitamin E combination group demonstrating the least change. Both plasma and cartilage concentrations of magnesium and tocopherol were significantly higher in the supplemented groups than in the animals that received the normal diet, which supports the potential role of magnesium deficiency in the pathogenesis of fluoroquinolone-associated chondrotoxicity.”

Does that mean that magnesium and vitamin E should be taken along with fluoroquinolones to mitigate damage? Maybe. It should be noted that magnesium inhibits fluoroquinolones both for better and for worse, and that the magnesium may decrease the ability of the FQ to fight the bacterial infection.

Additionally, it is noted in “Bactericidal Antibiotics Induce Mitochondrial Dysfunction and Oxidative Damage in Mammalian Cells,” that:

“Mice treated with clinically relevant doses of bactericidal antibiotics similarly showed signs of oxidative damage in blood tests, tissue analysis, and gene expression studies. This ROS-mediated damage could be reversed by the powerful antioxidant N-acetyl-l-cysteine (NAC) without disrupting the bacteria-killing properties of the antibiotics.”

Since NAC doesn’t disrupt the bacteria-killing properties of the antibiotics, it’s a better bet (IMO).

It is also noted in Musculoskeletal Complications of Fluoroquinolones: Guidelines and Precautions for Usage in the Athletic Population, that:

“A mitochondrial-targeted form of ubiquinone (MitoQ) demonstrated a larger protective effect than did untargeted ubiquinone. Oxidative stress frequently occurs in the mitochondria [22], and fluoroquinolone-induced oxidative damage to mitochondria in tenocytes and chondrocytes has been reported [26].”

Some “floxies” have found MitoQ to be helpful in healing fluoroquinolone-induced damage. Perhaps it can also prevent the damage from occurring.

If a loved one of mine had to take a fluoroquinolone, I would try to get him or her to load up on magnesium before-hand, and I would try to get vitamin E, NAC, and MitoQ into him/her while the FQ was being administered.

I certainly wouldn’t claim to know for sure that they would be safer while taking those antioxidants, but it’s worth a try.

Russian Roulette

People should be aware of the dangers of fluoroquinolones, and they should know that there is a certain amount of Russian Roulette that is being played with every pill administered. For better or for worse, I don’t think that people really understand fluoroquinolone toxicity until it happens to them. As scary as it is for those of us who have been hurt by fluoroquinolones to stand by and watch while our loved ones take these pills, some of us will have to do just that at some point. Maybe some of the fluoroquinolone-induced damage can be mitigated by the supplements mentioned above. I hope so.

 

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The Next Time Will be Worse: Cross-Reactivity of Fluoroquinolones

On every single warning label for each fluoroquinolone it says that if a person has experienced an adverse reaction to a quinolone, they should not be exposed to quinolones again.

The Cipro/ciprofloxacin warning label says:

“Ciprofloxacin is contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antimicrobial agents, or any of the product components.”

The Avelox/moxifloxacin warning label says:

“Contraindications: Known hypersensitivity to AVELOX or other quinolones.”

The Ciprodex ear drop warning label says:

“CIPRODEX® Otic is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication.”

Yet these warnings are disregarded regularly. I often hear from people who tell their doctor that they are allergic to Levaquin, and their doctor prescribes them Cipro. Or they tell their doctor that they are allergic to Cipro, but are still prescribed ofloxacin eye drops. There seems to be a lack of understanding of the cross-reactivity or one quinolone with all other quinolones.

The lack of knowledge and understanding is not because of lack of documentation. In an article in Current Pharmaceutical Design entitled “An Update on the Diagnosis of Allergic and Non-Allergic Drug Hypersensitivity,” it is noted that, “cross-reactivity among quinolones at both the IgE- and T-cell level is clinically well documented. Therefore, patients with hypersensitivity reactions to any quinolone should not be re-exposed to any antimicrobial agents of that class.”

Additionally, in The European Journal of Allergy and Clinical Immunology’s article, “Cross-reactivity between quinolones,” it is noted that, “We conclude that cross-reactivity between quinolone seems to be very important, and avoidance of any quinolone should be recommended to any patients who has suffered an allergic reaction to one of these drugs.”

When I told my doctors at Kaiser Permanente that I wanted fluoroquinolones to be put in my chart as a drug allergy, they couldn’t do it, because “fluoroquinolones” are a class of drugs, and they could only enter individual drugs into their system. In order to get all fluoroquinolones in my chart, I had to list every fluoroquinolone separately, because if I just said that I was allergic to Cipro, they would still give me Levaquin, or Avelox or Floxin. That’s a bit ridiculous seeing as it says ON THE WARNING LABEL that if someone has a history of hyper-sensitivity to one quinolone, they should avoid exposure to other quinolones. I’m sure that it’s easier said than done, but couldn’t there be some sort of cross-population of information that takes the “clinically well documented” cross-reactivity of quinolones into consideration? If someone has experienced a severe adverse reaction to Floxin, they shouldn’t take Levaquin—it’s not that difficult a concept. But systems are not currently in place to recognize, much less track or prevent, cross-reactivity or contraindications between drugs.

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If a person experiences a severe adverse reaction to a fluoroquinolone and they feel as if a bomb has gone off in their body and mind, they know that they have had an adverse reaction to a quinolone. Going through one severe adverse reaction to a quinolone is enough for most people, and they are likely to realize that they should never take a quinolone again. However, there are many people who experience mild-to-moderate adverse reactions to quinolones who don’t realize that they have had an adverse reaction in the past.

For the people reading this who may have taken a fluoroquinolone in the past but haven’t had a severe adverse reaction, I encourage you to think about your health history. After taking Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, or Floxin/ofloxacin, did you experience any of the following?

Insomnia
Anxiety
Loss of endurance
Muscle twitches
Tendon tears or ruptures
Depression
GI issues
Mild peripheral neuropathy

Those are all Warning Signs of fluoroquinolone toxicity. After the first time I took ciprofloxacin I had a twitchy eyelid and intermittent stomach cramping. I wish I had known that those symptoms were adverse reactions to the ciprofloxacin, and that I had known that I could no longer tolerate it. If I had known that I had experienced an adverse reaction to ciprofloxacin in the past, and if I had known that the warning labels say that people who have had a bad reaction shouldn’t take the drug again, I wouldn’t have taken it again and I would have avoided full-blown fluoroquinolone toxicity. There are a million “if only” scenarios around my adverse reaction to ciprofloxacin. I can’t turn back time and change anything though. I can only move forward and warn people. I hope that people heed my warning, and connect bizarre, seemingly innocuous symptoms like anxiety and sprained elbows, to the fluoroquinolone they took to treat an infection, and that they avoid future use of fluoroquinolones.

 

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