The labels for fluoroquinolone antibiotics, Cipro, Levaquin, Avelox, etc. have two black box warnings, warnings reserved for only the most serious and severe adverse effects of drugs:
Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.
Fluoroquinolones may exacerbate muscle weakness with myasthenia gravis. Avoid fluoroquinolones in patients with a known history of myasthenia gravis.
It is later noted that death can result from administration of fluoroquinolone antibiotics in people with myasthenia gravis, hence the warning that these drugs should be avoided in that population.
Central and Peripheral Nervous System Damage
In addition to the black box warnings, there is a 212 word warning of the adverse effects of these drugs on the central nervous system including, “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” and seizures.
On August 15, 2013, the FDA announced that they were changing the warning labels for fluoroquinolones to more adequately describe the risk of permanent peripheral neuropathy. The new warning labels will now note that peripheral neuropathy symptoms including “pain, burning, tingling, numbness, weakness, or a change in sensation to light touch, pain or temperature, or the sense of body position” can be caused by fluoroquinolones. They also note that peripheral neuropathy “can occur at any time during treatment with fluoroquinolones and can last for months to years after the drug is stopped or be permanent.”
Label Changes Based on Patient Reports
Also noted in the August 15th announcement was that the FDA was adding the warning of permanent peripheral neuropathy based on patient reports to their Adverse Event Reporting System (AERS) database. They note that, “the recent AERS review evaluated cases of fluoroquinolone-associated peripheral neuropathy with an outcome of ‘disability,’ reported between January 1, 2003 and August 1, 2012. The review showed a continued association between fluoroquinolones use and disabling peripheral neuropathy.”
Cipro was patented in 1983. It took 30 years of people reporting their peripheral neuropathy to the FDA for them to add an appropriate warning to the label.
Additional Warning – Autonomic Nervous System Damage
Since the FDA is slow on the uptake of vital information that should be listed on the warning labels of drugs, I will let you know that, in addition to the central nervous system and the peripheral nervous system, the autonomic nervous system is also damaged by fluoroquinolone antibiotics. The autonomic nervous system, also known as the involuntary nervous system, is composed of the nerves that control heart rate, digestion, respiratory rate, salivation, perspiration, pupil dilation, urination and sexual arousal. Damage to all of these body parts, controlled by the autonomic nervous system, are associated with fluoroquinolones.
How do I know this? In addition to the patient led research and patient descriptions of autonomic system damage, I know this by personal experience. Every one of those autonomic functions was negatively affected when I had a severe adverse reaction to Cipro that began December of 2011.
Though we don’t yet have scientific proof, as no studies have been published, I have personally heard from hundreds of patients experiencing similar symptoms. Since it took 30 years for the FDA to recognize the peripheral neuropathy, I wouldn’t be too keen to disregard the possibility that the autonomic systems is also affected.
Why hasn’t the FDA investigated autonomic neuropathy potentially associated with the fluoroquinolones? Perhaps because the malfunctions of the autonomic nervous system are very difficult to describe and detect and, though they are common among those who are suffering from Fluoroquinolone Toxicity Syndrome, they may not have risen to the top of the list of complaints in the AERS database. However, seeing as damage to the autonomic nervous system is serious and potentially life-threatening, the FDA should connect the dots and add an additional warning of autonomic nervous system damage to fluoroquinolone labels.
Overall Nerve Damage
Since multiple nervous systems are damaged by fluoroquinolones, it leads me to believe that fluoroquinolones damage nerves generally. Some early theories suggest that the fluoroquinolones induce the axons of nerves to degenerate and damage the myelin sheath protecting the nerves. Though I have several theories as to the damage mechanism for fluoroquinolones, anything conclusive other than reporting on what I experienced and have seen, is beyond my level of expertise. I do know that symptoms of nervous system damage are suffered from by the victims of fluoroquinolones and that they suffer mightily, sometimes permanently.
The possibility of fluoroquinolone toxicity is serious. With 26.9 million prescriptions for fluoroquinolone antibiotics dispensed in 2011 alone and the rate of fluoroquinolone induced peripheral neuropathy suspected at 1 per 6000, the number of potentially injured people is staggering. Worse yet, a 2011 study published in BioMed Central, found that 39% of fluoroquinolone therapy in hospital patients was unnecessary. Who knows what the rate of unnecessary fluoroquinolone use is in the general population.
Fluoroquinolones are dangerous antibiotics that are often used to treat sinus infections, urinary tract infections, upper respiratory infections, prostate infections, etc., infections that could be treated with a safer antibiotics. It is absurd and wrong for people to suffer from chronic and often debilitating nerve damage and other health conditions as a result of a prescription antibiotic, especially when other, safer alternatives can be used.
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 www.floxiehope.com.
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This post was published previously on Hormones Matter in 2013.
I had all the aches, pains, nerve damage and i also had Shingles off and on for several years. I took cipro off and on for several years due to diverticulitis. I was in my early 40’s. It took me a while to figure out cipro caused all of this. I have also had tendon problems and surgery on ankle. What finally helped me get rid of the shingles and get my health back was Low Dose Naltrexone. It helped immediately.
I am going through a battle from Levaquin, , I walk by faith and not by sight, My faith in Christ Jesus will make me whole, when all other physicians will not listen; talk to the GREAT PHYSICIAN ( JESUS CHRIST ) I am trusting in God for my healing!!!
My friend who is 47 was prescribed Cipro for her cough in February. She has been on a very low dose of Lexapro for 8 years- besides Cipro, she was put on prednisone at the same time for the cough. She took ibuprofen due to headache- now she is ‘seemingly’ near death- She feels like her whole body is shutting down and she is totally disabled, had to quit working, she cannot drive- she feels like her whole insides are vibrating, her brain is, her heart races, she cries, she is SUFFERING and to see how FAST this has all happened to her is the most perplexing and disturbing thing I’ve ever witnessed- what hope does she have? We (her husband & I) took her to a neurologist last week- he seems perplexed. It SEEMS doctors are not acknowledging the severity of this reaction. She has become plagued with suicidal thoughts- her husband took her to a counselor who recommended hospitalization but the hospital sent her home. She is SO WEAK that she barely speaks- and she is extremely sensitive to sound. Her initial symptoms after 3 days of Cipro was skin turning red, her legs she said felt like ‘jello’, her heart would race- dizziness. She quit work unable to do her job. She now cannot drive either. Mostly she’s weak, no strength, very distressed and feels her whole nervous system is in chaos- any help out there any suggestions would be GREATLY appreciated, this is way beyone any of us to understand! Or help her!! Thank you-
Hi Valerie,
I’m so sorry for everything that your friend is going through! I’m glad that she has supportive friends and family who are doing research for her.
Most importantly, please tell her that she will get better. Hope is incredibly powerful, and do anything you can to help her to maintain hope. There are stories of recovery that have a lot of helpful tips in them on the site http://www.floxiehope.com. Additionally, here is a post about some things to do when first suffering from one of these reactions – https://floxiehope.com/2015/10/12/im-floxed-now-what/.
I also suggest that you read this article – https://www.hormonesmatter.com/fluoroquinolone-antibiotics-thyroid-problems-connection/ – and get all of her thyroid antibodies tested.
Anything that can be done to calm down her autonomic nervous system and tone her vagus nerve can be helpful. Things like meditating, breathing exercises, laughter, minimizing stress, etc. can be helpful. I found acupuncture to be helpful in my journey through fluoroquinolone toxicity. Here are some other tips for toning the vagus nerve – https://selfhacked.com/2015/07/30/28-ways-to-stimulate-your-vagus-nerve-and-all-you-need-to-know-about-it/.
I drink water that has gone through reverse-osmosis to remove the fluoride. It’s worth looking into.
Magnesium helps many people.
Check her B vitamin levels and supplement as necessary.
Iron helped me a lot.
If I were to do it all over again, I would go straight to the beach. I know that sounds overly simplistic, and perhaps unrealistic, but the healing powers of the sea are lovely – https://floxiehope.com/2015/12/02/the-healing-power-of-the-sea/.
Here is a post about things that can help one get through the anxiety – https://floxiehope.com/2015/06/22/treating-fluoroquinolone-anxiety/. Even though the article linked to recommends against it, kava (and even benzodiazepines) can be helpful when used sparingly and for a short time only.
I hope that those things help.
Regards,
Lisa
I am late to comment but I cannot stress enough the importance of probiotics to alleviate symptoms of these antibiotics. They kill off both good and bad bacteria. It sounds like gut flora has been decimated- your gut is where the large majority of your neurotransmitters are produced. Cipro killed them off. Hence the pain, vibrating, etc. It is probably a GABA deficiency. You’ve got to put the good bugs back in. The good bugs make GABA in your gut, and GABA calms your CNS. Get some kefir grains and make kefir- drink as much as you can stand 10, 20,30 cups a day even. Eat other fermented foods and kombucha for variety. It takes a very long time to repopulate your gut but it will help.
I am sorry that your friend is so extremely ill. In my 7+ years of Fluoroquinolone Toxicity I have found that Sublingual B-vitamins, Magnesium spray oil (to relieve muscle spasms) have both proven very helpful. However, the best treatment that I have found is Infra-Red Light treatments (full-body). They are available at spas, or one can even puchase a treatment bed. (It looks like a tanning bed.) When I started my treatments, I could barely walk from my car to the treatment room. The treatments boost collagen production & help with detoxing the body. I have been taking them for 4 or 5 years. I took them everyday for about 3 months, then down to 3 per week for several years. I take 1 or 2 per week now. Can’t make it without them! Prayers for all.
Valerie-
I have found hyperbaric chamber treatments to be life saving. Please read up on it and see if there are any places near you who offer the chamber. I am 3 years out and have literally tried just about everything to get better. Good luck!
cipro has ruined my health for many years and I will never take it again for any reason. It was prescribed for me several times for U.T.I.’s. It left me with a non-diabetic peripheral neuropathy, a neurologist did testing twice with a diagnosis of peripheral neuropathy. The suffering that never ends is not worth ever taking Cipro. Even two years ago when I had another U.T.I. and went to an emergency room the doctor, after confirming U.T.I., prescribed Cipro. I told him on the spot that I could not take Cipro because of what it had already done to me and that the last time I argued with my doctor and lost the argument, my legs started within one day of Cipro hurting even worse that I called my doctor and refused to take another Cipro pill and then he called in what I requested, Amoxicillin, and it cured the UTI just as fast as Cipro would. So, the last time I once again tried to do what the doctor wanted me to take (Cipro), I told the emergency room doctor that my regular doctor had to call me in something else after a couple days of Cipro, he still said “well, you have a bad UTI and Cipro is the very best antiobiotic on the market to take care of your U.T.I., I told this doctor that I truly believed that the Cipro caused my peripheral neuropathy in the first place and made it worse after I had been diagnosed with peripheral neuropathy to the point that the pain med oxycodone did not work as the pain was even worse back on Cipro. The emergency room doctor’s insistence, I took Cipro for 2 days and could not stand the increased pain in my legs as well as other symptoms, I called the emergency room and told the nurse I had to have Amoxicillin as I was not going to swallow another Cipro pill and he then prescribed Amoxicillin which cured the U.T.I. I also truly believe that Cipro has caused my other autonomic nervous system problems relating to my heart and nervous system. The second neurology testing showed I was getting peripheral neuropathy problems in my arms. Cipro’s crippling, painful results to my body has put me into fear about ever using any other med prescribed by any doctor. Now, when a doctor prescribes a drug I always check drug interaction checker myself and don’t take any med if it shows an interaction and when doctor asks me how the med worked for me, I tell the doctor I don’t know cause I didn’t take it and threw it in the garbage can. I truly feel my quality of life was ruined by the Cipro. I know there have been class action lawsuits regarding Cipro of which I have never been involved but always felt I should be due to Cipro’s damage to my body with resulting pain that causes me to take a pain med I never wanted to have to take to get some pain relief. I have no doubts in my mind that if I had refused to take Cipro I would not have to take pain med to help to ease the pain and other symptoms I have caused by Cipro.
Hi Jean,
I am so, so, so sorry for everything that you have been through!
In 2013 the FDA changed the warning labels for Cipro and other fluoroquinolones to note that peripheral neuropathy is a serious effect of the drugs and that the PN can be permanent. (But please know that it is not always permanent – hope for recovery truly is helpful.) In their announcement, they also noted that people should stop taking the fluoroquinolone right away if they experience PN or other side-effects. You were right to stop taking it! I wish that your doctors had listened to you better. Here is some information from the FDA – http://www.fda.gov/Drugs/DrugSafety/ucm365050.htm. If you want to forward it to your doctors, well, they really do need to know this stuff.
There are some lawsuits going on right now specifically for people who have peripheral neuropathy after taking Cipro, Levaquin or Avelox. If you want to talk to some attorneys about being in on the cases, there is a list of attorneys working on FQ PN cases on http://floxiehope.com/fluoroquinolones-links-resources/. Just scroll down to the “Law Firms” section.
I hope that you find some healing! Again, I am so sorry for what these drugs have done to you!
Regards,
Lisa
There is an open lawsuit for Peripheral Neuropathy (Levaquin, Avelox fluoroquinolone antibiotics), and they accept also those who are suffering
with Peripheral Neuropathy caused by Ciprofloxacin;
I am still suffering several physical ilnesses caused by all three …. taken
along the past years; I also have to “thank” a lot those physicians who abused of the body of others; the pharmaceutical industry has a lot of power, also on “controlling” physicians, etc., and it’s a matter of the same old problem : money; I know for sure that LORD GOD is the only Physician WHO will never be part of this horrendous theather of the culture of death; may GOD blesses this whole world in turmoil;
If you were given the generic form of this drug, no lawfirms
Will touch it. Generic drugs are lawsuit exempt. An outrage!
I agree when I first got hit my entire immune system went insane. I had over 60 mouth sores like cancers and every time I do something to try and boost the immune system they come back. It seems to trigger a herpes like virus or cold sore I don’t know what but it def affects the immune system. Mine is on hyper mode with stinging over my entire body.. Through me hyperthyroid messes up every system in our body.. I agree 100 percent this triggered shingles, how to prove it I cant
Bob, I don’t think that my response is going to help my credibility, unless you consider an apologetic response to be something that enhances credibility. I can’t seem to find that figure again. I am sure that I found it somewhere, but I can’t seem to find it again and I apologize for that.
Here are my current thoughts on rates of adverse reactions to fluoroquinolones – No one has a clue. Not any idea whatsoever. When the FDA updated the warning labels for fluoroquinolones to add “permanent peripheral neuropathy” to them, they stated, “The recent AERS review evaluated cases of fluoroquinolone-associated peripheral neuropathy with an outcome of “disability,” reported between January 1, 2003 and August 1, 2012. The review showed a continued association between fluoroquinolones use and disabling peripheral neuropathy. However, because AERS is a spontaneous reporting system, an incidence of peripheral neuropathy, especially permanent damage among patients exposed to these medications, cannot be calculated.” http://www.fda.gov/downloads/Drugs/DrugSafety/UCM365078.pdf Here is an article from some Swedish researchers that focuses more specifically on peripheral neuropathy, but they note, like the FDA does, that rates of adverse reactions are difficult to determine from the voluntary reporting databases – http://jac.oxfordjournals.org/content/37/4/831.long Here is an article that estimates the general rates of adverse reactions to fluoroquinolones at 4.4-20% – http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3249743/?report=printable That kind of spread implies that no one really has a clue what the rates of adverse reactions are. The article that was linked to in the post gave over-all adverse reaction rates calculated by measuring trips to the emergency room triggered by adverse reactions to drugs. This is the wrong way to calculate adverse reactions to fluoroquinolones. Peripheral neuropathy, and most other adverse reactions to fluoroquinolones, will not send you to the ER – but they are very real adverse reactions none-the-less.
There are a couple of sample groups that could give us a good idea of real rates of adverse reactions to fluoroquinolones – the US Postal Workers who took Cipro prophylactically after the Anthrax scare, and later sued because of adverse reactions (but I don’t know much about the lawsuit or the result – sorry, I haven’t researched that yet), and Gulf War Veterans who took 30-120 days of Cipro. I have not seen long-term studies of either of these groups that focus on fluoroquinolone ADRs. I’m sure that they are interesting, if they exist.
Here are further thoughts on the notion that no one has a clue about the rates of adverse reactions to fluoroquinolones – http://floxiehope.com/2013/08/09/is-fluoroquinolone-toxicity-rare/
Again, I apologize for the lack of clarity that led to the lack of credibility in the original post. Thank you for reading it!
I think you make some valid points, but when I go to one of your links(1 per 6000 peripheral neuropathy), it sends me to the embedded article that does not even talk about peripheral neuropathy. I am just confused by this and makes me question all of this as being made up or valid.
Thank you so much for the comment, Keekrules! That’s really interesting! When I first had my adverse reaction to Cipro, it seemed as if I aged ten years in just a couple of weeks. EVERY system in my body was going hay-wire. It seemed as if the Fluoroquinolone Toxicity had exacerbated every single pre-existing weakness that I had – and it created some weaknesses that I didn’t have before too. Other people seem to have similar stories. I wonder if the Levaquin triggered the dormant shingles that were in your system. Or maybe the Levaquin weakened the protection around your nerves and allowed the shingles to emerge and attack your nerves. I’m not sure, to tell you the truth, because your case is the first time I have heard of a fluoroquinolone triggering shingles. I have heard of them triggering just about everything else though, so I have no doubt that you are correct, that Levaquin led to your outbreak. Did you have any of the other symptoms of Fluoroquinolone Toxicity? I list many of them in this post and also on http://www.hormonesmatter.com/fluoroquinolones-101-antibiotics-to-avoid/.
Several days after starting a prescription for Levaquin for a cough, I began with the symptoms shingles. By day 7, I was diagnosed with Shingles. Which you wouldn’t really think much about, but I was only 40 years old! My doctor insisted there was no relation to the prescription. I don’t agree! Shingles is a nervous system illness/disease.
Shingles are apt to occur when your immune system is under stress. If you had chicken pox, the immunity lasts about 30 years, so they can appear anytime after that. It’s not just a disease of old people.
I had all the aches, pains, nerve damage and i also had Shingles off and on for several years. I took cipro off and on for several years due to diverticulitis. I was in my early 40’s. It took me a while to figure out cipro caused all of this. I have also had tendon problems and surgery on ankle. What finally helped me get rid of the shingles and get my health back was Low Dose Naltrexone. It helped immediately.