adverse reaction cipro Archives

When Investigating Fluoroquinolone Reactions, Move Beyond the ER

Published on March 13, 2024

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When trying to determine the danger associated with a drug, the number of Emergency Room (ER) visits that result from use of that drug is often cited. While anaphylactic shock and other acute ER worthy reactions should certainly be measured, exclusively looking at how often a drug leads to ER visits is not a comprehensive, or accurate, way of determining the danger of a drug. Simply looking at ER visits leads those trying to determine the risk associated with a drug to fail to take into consideration chronic illnesses and conditions that are caused by prescription drugs, and leads them to only recognize adverse reactions that are immediately life-threatening. Acute and temporary reactions are over-emphasized while systemic and chronic reactions are under-recognized.

When Only ER Visits are Considered, Fluoroquinolones Look Safe

For example, when comparing the safety profiles of different antibiotics, the following was noted in the Journal of Family Practice:

The Centers for Disease Control and Prevention estimates that adverse events from FQs (fluoroquinolone antibiotics) leading to emergency department (ED) visits occur at a rate of 9.2 for every 10,000 prescriptions. That’s higher than the ED rates for cephalosporins (6.1 per 10,000) and macrolides (5.1 per 10,000), but far lower than for penicillins (13 per 10,000), clindamycin (18.5 per 10,000), sulfonamides (18.9 per 10,000), and vancomycin (24.1 per 10,000).

Thus, fluoroquinolone antibiotics are slightly less safe than cephalosporins and macrolides, but slightly more safe than penicillins, clindamycins, sulfonamides and vancomycin, right? That’s what the statistics around trips to the ER clearly note. However, what these data fail to take into account is that adverse reactions to fluoroquinolones are not generally allergic or acute reactions, whereas adverse reactions to penicillins, clindamycins and sulfonamides are. The ER is the place to go when suffering from an acute reaction. When a patient is going through anaphylactic shock or inflammation that is threatening their life as a result of an allergic reaction, the ER is where their life can be saved. It is where epinephrine, steroids and antihistamines can be administered, and those drugs can save the life of a patient experiencing a severe allergic reaction. Adverse reactions to fluoroquinolones are not allergic reactions. Though anaphylactic shock can occur as a result of taking a fluoroquinolone, it is an uncommon adverse effect.

More often, those experiencing adverse reactions to fluoroquinolones experience weakening of all of the connective tissues in their body (especially tendons), peripheral neuropathy, insomnia and/or other CNS related symptoms, debilitating fatigue, dysautonomia, etc. None of these conditions warrant a trip to the ER, yet they are serious and severe symptoms of Fluoroquinolone Toxicity Syndrome. In only looking at ER visits when trying to determine the safety of a drug, the symptoms of an adverse drug reaction that are chronic, as opposed to transient like allergic reactions, are systematically disregarded and the safety profile of the drug is not accurately represented.

Conditions that can be quantified and measured using tests and data-points that are currently easily at the disposal of doctors, and conditions that can be rectified through the tools that are available to doctors – like allergic reactions to penicillin – are recognized. Everything else is considered to be non-existent, mysterious or all in a patient’s head (as if what is in a patient’s head isn’t important). Systemic, chronic injuries caused by fluoroquinolones and other drugs are not seen because only adverse drug reactions that result in ER visits “count.” This is a problem because if doctors are only looking at a single data-point for determining the safety of a drug, and that data-point is the wrong one to look at, no one is getting an accurate or complete picture of the safety of drugs.

The frequency of adverse reactions to drugs that are more chronic and systemic in nature can be determined through long-term studies that take into consideration things like lifetime tolerance thresholds, delayed adverse reactions, etc. They should be implemented so that patients and doctors alike can have an accurate and comprehensive notion of the dangers of the drugs that are prescribed. ER visits are easy to calculate while long-term studies that recognize issues that are difficult to quantify (because the right tests are difficult to find and expensive to administer) are very difficult to conduct. Therefore, out of laziness, inertia and lack of funding, the wrong data is considered and drugs that cause chronic issues are falsely thought to have inflated safety records.

Asking the wrong question and expecting the right answer has never served anyone well, and doing that systematically in medicine is not serving patients or doctors well. It is not good for healthcare and it is not good for anyone seeking the truth about adverse drug reactions. If one wants to know the answer to the question of “How safe are fluoroquinolones?” we must move beyond trips to the ER and standard acute adverse reactions. Simply looking at ER visits is intellectually shortsighted and it leads to a false sense of security when prescribing dangerous drugs. Perhaps gathering some additional data-points should be considered.

Information about Fluoroquinolone Toxicity

Information about the author, and adverse reactions to fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin) can be found on Lisa Bloomquist’s site, www.floxiehope.com.

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If you have experienced injury or illness from a fluoroquinolone antibiotic, share you story.

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This article was published previously in December 2013.

Who Reads the Drug Warning Labels?

by Lisa Bloomquist

Published on August 19, 2015

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I have a confession – I didn’t even glance at the warning insert that came with my Cipro prescription. I didn’t even think about reading it. I didn’t think for a second that I needed to be worried about the side-effects of an antibiotic. I assumed that all antibiotics were safe, thoroughly tested, had few side-effects and that any side-effects that they had wouldn’t hurt ME. After all, I was a fit, strong 32 year old with zero health issues other than the urinary tract infection that I was trying to treat. I thought that I had nothing to worry about and that medicine generally and antibiotics specifically fell into the category of things that do good, not harm. So when I developed severe Central, Peripheral and Autonomic Nervous System malfunctions and inflamed tendons after taking Cipro, I was shocked and shaken that an ANTIBIOTIC that is prescribed every day to treat simple urinary tract and other infections, could cause me, a healthy and fit woman, to be suddenly systemically sickened.

I suppose that, since I didn’t read the warning label, I have to take a certain amount of personal responsibility for what happened to me. Officially, I was warned. I should have known that Cipro, one of the most popularly prescribed broad-spectrum antibiotics on the market, could cause tendonopathy, renal failure, rash, anemia, hepatic failure, hallucinations, seizures, permanent peripheral neuropathy, etc. I should have read the warning label so, at the very least, I would have known that when I experienced inflammation and weakening of every tendon in my body (lightly referred to as tendonopathy – as if that even comes close), hives all over my body, loss of memory and reading comprehension, inability to concentrate, peripheral neuropathy, anemia, etc., that I was experiencing an adverse reaction to the drug that I had taken. Should’ve, would’ve, could’ve. I lived and learned and will certainly read warning labels in the future. However, I don’t think that I am unusual in not bothering to read the warning label that accompanied my prescription for antibiotics. Do other people read drug warning labels?

Doctors certainly don’t seem to read drug warning labels. Every single doctor who I asked whether or not Cipro could have caused my symptoms said that it couldn’t have, despite the fact that the majority of my symptoms are listed on the warning label.

And even if I had read the warning label, would I have been sufficiently warned? I assumed, as I think most people do, that drug side-effects are transient, that they are stopped as soon as administration of the drug is stopped, or at least as soon as the drug is fully metabolized. I had no idea that a drug could cause a syndrome that would take me years to recover from. Nowhere on the warning label does it say that side-effects can be long-lasting and, when I took Cipro in 2011, nowhere on the label was the word “permanent.” It was only added to the warning label in 2013 in reference to permanent peripheral neuropathy.

Who would think that a drug, an antibiotic no less, could cause a chronic syndrome that includes pain and nerve destruction? Again, doctors certainly don’t because not a single one acknowledged that my cascade of physical and mental issues that cumulatively was a toxicity syndrome, was caused by Cipro. This was despite not only the warning label but also thousands of patient reports, lawsuits, media reports and studies that show that I was not crazy or suffering from sudden onset of an autoimmune disease; I was poisoned by a prescription antibiotic.

Even if I had read the warning label, I likely would have assumed that side-effects were rare. The people who acknowledged that Cipro caused the damage that it caused in me dismissed the possibility that what happened to me could happen to them by saying that adverse effects of fluoroquinolone antibiotics (Cipro, Levaquin and Avelox) are rare. How, I wonder, would anyone have a clue whether or not Fluoroquinolone Toxicity Syndrome is rare? Given that the onset of symptoms is often delayed by days, weeks or even months after administration of the drugs has stopped; that doctors and patients alike are looking for allergic reactions when they are looking for adverse drug reactions, not systemic breakdown in the form of a syndrome; that the doctors who prescribe fluoroquinolones (general practitioners and emergency care doctors) are typically not the same doctors who treat the symptoms (rheumatologists, neurologists, psychologists, etc.); that there appears to be a tolerance threshold for fluoroquinolones (meaning that you can take it up to your threshold point without incident but once you cross your threshold point you suffer from a severe onslaught of symptoms), a concept that those who are doing drug studies don’t even seem to consider; and that almost everyone in the medical field is in complete denial about the dangers of these drugs, how in the world would anyone, including the FDA, have a clue what the frequency of adverse reactions to these drugs is???

Risk is not properly communicated via drug warning labels. Risk is a function of severity and frequency. Individual adverse symptoms are listed on drug warning labels, but nowhere does it state how severe each symptom can be, or whether multiple symptoms can occur simultaneously, or if the drug can trigger a long-lasting syndrome that itself is a chronic disease. How can people possibly assess the risk of experiencing severe, life-altering, long-term side-effects if it’s nowhere on the warning label that those things can happen? And if frequency of adverse reactions is systematically under-acknowledged for the reasons listed above, how can people possibly assess the likelihood that an adverse reaction will happen to them?

Perhaps doctors and patients alike are doing the sensible thing in not bothering to read drug warning labels. If the information that they give is arbitrary and they don’t help people to assess the actual risk associated with a drug properly, they should be ignored.

The only party that the warning labels are truly serving is the drug companies, because if they can say that they warned you through the paperwork that accompanies dangerous drugs, you can’t sue them.

So who is appropriately communicating the real risk of adverse drug reactions to patients? Who is communicating the risk to doctors? How is anyone supposed to know the real severity and frequency of adverse drug reactions? We’re not getting that information – from anyone. The FDA is failing to provide that information. Neither doctors nor patients are demanding that information. Everyone is assuming that adverse drug reactions are rare, while the number of deaths from prescription drugs climbs and the number of chronic diseases that people suffer from, many of which are caused by adverse drug reactions, skyrockets.

Perhaps it is time that we start demanding that drug warning labels mean something. They should accurately and completely reflect the real dangers associated with each and every drug. Frequency of adverse events should be noted on the warning labels. This is not too much to ask for. Patients, doctors and everyone else involved should insist on it. We deserve to know.

For a list of warnings that should be on the label for fluoroquinolone antibiotics, please visit www.ciproispoison.com.

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More people than ever are reading Hormones Matter, a testament to the need for independent voices in health and medicine. We are not funded and accept limited advertising. Unlike many health sites, we don’t force you to purchase a subscription. We believe health information should be open to all. If you read Hormones Matter, like it, please help support it. Contribute now.

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This article was published previously in October 2013.

A Fragmented Balance: Life Post Cipro

by BJS

Published on December 23, 2013

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It has been seventeen months since I took three doses of Cipro and seventeen months of endless education of a degree in which I will never receive nor have ever been interested in to begin with. Pushed into an unfamiliar world due to a prescription of an antibiotic for an infection I did not even have.

I have never been one to like medications and because I have always been generally healthy, I have rarely ever needed them. A suspected urinary tract infection is what started this whole mess. As it turned out, it was bladder irritation due to ice tea, not an infection. If I had listened to my gut I would not have swallowed the poison. Instead, I listened to my doctor. Why? Because I had been going to her for quite a long time, she knew me best; she is supposed to have my best interest at heart. In fact, she knew me so well that when she gave me the prescription she told me NOT to look at the side effects because I would choose not to take it. She knew I hated taking medication. It was JUST an antibiotic. That’s what she said and that is what I told myself.

Well Cipro is NOT just an antibiotic for some people. For some people it is poison; it is a game of Russian roulette with all chambers full. I will spare you the details of the thirty plus symptoms it has caused and continues to cause, but know that my life has not been the same since and it never will be. Even if my body recovers, it will never be the same. It can never give me the time back that I have not been able to spend with my children because I was laying in bed icing my hamstrings, or the hikes I have had to avoid because of the muscle loss; the time I have spent researching alternative ways to heal because the medical community has NO clue. Life will be different, from here on out.

I failed to mention the worst side effect of Cipro toxicity – how all of this can consume you, swallow you whole and spit you out in pieces. Fragments. Trying to fix yourself while being sick is not an easy task. It is an unfair task actually. It can make you angry; it can make your friends and your family angry. They don’t want to hear it and you are too tired to listen to yourself anymore.

I became silent.

During my silence an evolution occurred. It has started me on a new journey; a delicate balance of before, after, and mostly today. The object of my new journey is to gather the fragments each day as if they are new and polish them, repaint them and do my best to put them back together again. The object is to make a new art piece, a new me, post Cipro injury and to hope that people will admire the new me, but more importantly, that I will admire the new me, the stronger me, the less naive me. I think will call my art piece “Fragmented Balance”.

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Hormones Matter is conducting research on the side effects and adverse events associated with the fluoroquinolone antibiotics, Cipro, Levaquin, Avelox and others: The Fluoroquinolone Antibiotics Side Effects Study. The study is anonymous, takes 20-30 minutes to complete and is open to anyone who has used a fluoroquinolone antibiotic. Please complete the study and help us understand the scope of fluoroquinolone reactions.

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