Study Shows that Quinolone Ear Drops Increase Rates of Eardrum Perforation in Children

A recent study published in Clinical Infectious Diseases, “Quinolone Ear Drops After Tympanostomy Tubes and the Risk of Eardrum Perforation: A Retrospective Cohort Study” found that children who were prescribed quinolone (fluoroquinolone) ear drops were significantly more likely to experience perforated eardrums than those who used an alternative, non-fluoroquinolone, antibiotic ear drop – neomycin.

In the study, researchers tracked Medicaid data for almost 100,000 children who underwent ear tube surgery (tympanostomy). The researchers then compared post-operative eardrum perforation rates after kids were given either quinolone or neomycin antibiotic ear drops.

The researchers found that children who received quinolone ear drops were 60% more likely to suffer eardrum perforations than those who received neomycin ear drops, and the rates of eardrum perforation were even higher in the children who were given quinolones together with steroids.

One of the study’s authors, Almut Winterstein, noted, “Evidence on quinolones’ detrimental effects on soft tissues, animal studies, clinical trials and observational studies overwhelmingly point to the possibility that quinolones could contribute to the development of persistent eardrum perforations.”

Comments from Victims

When a story about this study was posted on The Fluoroquinolone Wall of Pain Facebook page, several people noted that their children had suffered adverse effects of fluoroquinolone ear drops. The comments included:

“My 14 year old was prescribed Cipro drops multiple times when he was younger for ear infections and after tubes were put in twice. Last month he had surgery to repair a hole in his eardrum. Now I know better…10 years ago I didn’t know.”

“Our daughter was prescribed these for years–always had a bottle on hand to start if we suspected an infection (as per her doctor) Now at 17 she’s had two progressively invasive surgeries to repair an ear tube hole that keeps popping open. She also has hearing loss due to surgeries. Next up is a specialist and a more invasive graft to get it to close. Definitely going to follow up on this research and results……”

“My daughter had two sets of tubes with these drops prescribed both times. At 6, the doctors determined she needed a 3rd set but would not give them to her due to severe perforations of her ear. They dismissed the perforations as caused by ear drum ruptures from ear infections. Now they are telling me that she may always have pressure related problems and may never be able to scuba dive. I refused the drops for her after I was floxed in 2015 by taking Cipro.”

It is absolutely heartbreaking to hear of children being hurt by fluoroquinolones. My heart aches for the parents of these children as well. They are victims of these drugs too.

Quinolones/Fluoroquinolones Damage Connective Tissues

I’m really glad that this study was done, and I commend Doctors Alrwisan, Antonelli, and Winterstein for conducting it. I hope that pediatric ENTs will hear about this study and understand that quinolone/fluoroquinolone ear drops are dangerous, and that they can lead to perforated ear drums and other health complications.

I understand that the alternative to quinolone/fluoroquinolone ear drops, neomycin, has adverse effects as well, but it does not damage connective tissues or lead to eardrum perforation at near the rate that quinolone/fluoroquinolone ear drops do. Quinolone/fluoroquinolone ear drops are dangerous, and they’re not only dangerous to ears. As Bill’s Story on www.fqwallofpain.com notes, other connective tissue problems can occur after using quinolone/fluoroquinolone ear drops. Bill states:

“I went to see my doctor and was prescribed ciproxin eardrops for an ear infection.They didn,t seem to help my ear so went back to doctors and told him my shoulders were very sore and I had a strange rash on my back.He suggested I may have tendonitis.”

Another “floxie” friend stated that:

“Ofloxacin Eardrops have ruined my life. It has left me disabled in horrible pain totally bedridden.”

Fluoroquinolones, in any form, are dangerous drugs that adversely affect all bodily systems–from tendons, to nerves, to hormones, to the gut biome, and more.

Fluoroquinolones should never be used unless a person is facing a life-or-death need, AND there are no safer alternatives. For all the children in the study who were given quinolone ear drops after ear tube surgery (tympanostomy), there was an alternative. Though the alternative, neomycin, is imperfect, it is safer than quinolone/fluoroquinolone ear drops.

Delayed Effects

Fluoroquinolone adverse effects are often delayed for weeks, or even months, after administration of the drug has stopped. This makes recognition of fluoroquinolone adverse effects difficult, to say the least. Retrospective cohort studies, such as, “Quinolone Ear Drops After Tympanostomy Tubes and the Risk of Eardrum Perforation: A Retrospective Cohort Study” are a good way to identify delayed adverse effects of fluoroquinolones. The researchers who conducted “Quinolone Ear Drops After Tympanostomy Tubes and the Risk of Eardrum Perforation: A Retrospective Cohort Study” looked at years of medical data (from 1999 to 2006) to determine that the rates of eardrum perforation were higher among those who were prescribed quinolone/fluoroquinolone antibiotic ear drops than those who were prescribed neomycin antibiotic ear drops. The eardrum perforations didn’t happen immediately upon administration of the quinolone/fluoroquinolone ear drops, rather, they were a delayed effect that was only uncovered by looking through medical records.

Fluoroquinolone toxicity resembles many recognized illnesses, including all autoimmune diseases, many neurodegenerative diseases, fibromyalgia, ME/CFS, psychiatric illnesses, digestive problems, autonomic nervous system disorders, diabetes, and more. It would be fascinating, informative, and useful if studies were conducted that looked at medical records of people who had been prescribed antibiotics, then compared future health outcomes to see if those who were prescribed fluoroquinolone antibiotics were more likely to be diagnosed with autoimmune diseases, fibromyalgia, ME/CFS, psychiatric illnesses, digestive problems, autonomic nervous system disorders, diabetes, etc. than those prescribed non-fluoroquinolone antibiotics. I would certainly bet on a strong correlation between fluoroquinolone use and many illnesses, but my bets mean nothing until the studies get done. I am hopeful that more studies examining the long-term effects of fluoroquinolones on multiple areas of health get done. It is only with research, data, and science, that the harm that these drugs do will be adequately recognized.

 

 

Mitochondria, Neuropathy, HIV, and Fluoroquinolones

Mitochondria and Peripheral Neuropathy – Article out of Johns Hopkins

I highly recommend reading this article –

Feet First? Old Mitochondria Might Be Responsible For Neuropathy In The Extremities

It’s a fascinating article out of Johns Hopkins Medicine.

It goes over the connection between mitochondrial damage and peripheral neuropathy.

As an explanation as to how dysfunctional mitochondrial lead to peripheral neuropathy, the article notes that:

“He and his colleagues suspected that the reason (for peripheral neuropathy) might lie within mitochondria, the parts of cells that generate energy. While mitochondria for most cells in the body have a relatively quick turnover — replacing themselves every month or so — those in nerve cells often live much longer to accommodate the sometimes long journey from where a cell starts growing to where it ends. The nerve cells that supply the feet are about 3 to 4 feet long in a person of average height, Hoke explains. Consequently, the mitochondria in these nerve cells take about two to three years to travel from where the nerve originates near the spine to where it ends in the foot.”

Peripheral Neuropathy and HIV/AIDS

It is also noted in the Johns Hopkins article that peripheral neuropathy is “a condition that often accompanies other diseases including HIV/AIDS.”  I wonder, is peripheral neuropathy in HIV/AIDS patients caused by the disease, or the treatment for the disease?  In Mitochondria as a Target of Environmental Toxicants, it is noted that:

“Another example is the nucleoside reverse transcriptase inhibitors (NRTIs) that are used to combat human immunodeficiency virus (HIV) infection. NRTIs act by inhibiting the reverse transcriptase activity required for viral replication. They have been highly successful in treating adults and in preventing transmission of HIV from pregnant mothers to their children, but unfortunately many NRTIs also inhibit the mtDNA polymerase γ. This has resulted mtDNA depletion- and mutation-mediated mitochondrial toxicity, and even death, in patients and in animal models (Benhammou et al., 2007; Blanche et al., 1999; Chan, 2007; Claessens et al., 2003; Divi et al., 2010; Kohler and Lewis, 2007). Similar effects have been observed with nucleoside analogs intended for other viruses as well (McKenzie et al., 1995). Thus, chemicals that damage mtDNA or alter its copy number can have very serious health consequences.”

Pharmaceuticals and Mitochondrial Damage / Peripheral Neuropathy

I think that the article out of Johns Hopkins is great, and I greatly appreciate the research that has been done.  However, I suspect that the researchers missed an opportunity in not noting that drugs that deplete mitochondrial DNA are responsible for many cases of mitochondria related peripheral neuropathy.

The damage to mitochondria done by NRTIs is well documented.

Other drugs, including fluoroquinolone antibiotics – Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin – are also well-documented as being destructive to mitochondria AND causing peripheral neuropathy.

In the article, Calcium Signals Are Affected by Ciprofloxacin as a Consequence of Reduction of Mitochondrial DNA Content in Jurkat Cells, it is noted that ciprofloxacin, a fluoroquinolone depletes mitochondrial DNA content.  It is also noted in the article, Delayed cytotoxicity and cleavage of mitochondrial DNA in ciprofloxacin-treated mammalian cells, that ciprofloxacin treated cells show a loss of mitochondrial DNA.

Though Delayed cytotoxicity and cleavage of mitochondrial DNA in ciprofloxacin-treated mammalian cells was published in 1996, it was not until 2013 that the FDA added the risk of permanent peripheral neuropathy to the warning labels for fluoroquinolones.   The case study, Permanent Peripheral Neuropathy: A Case Report on a Rare but Serious Debilitating Side-Effect of Fluoroquinolone Administration illustrates the severity of peripheral neuropathy brought on by (the mitochondrial damage done by) fluoroquinolones.

It is also noted in the FDA’s April 27, 2013 Pharmacovigilance Review, “Disabling Peripheral Neuropathy Associated with Systemic Fluoroquinolone Exposure,” that the mechanism for action through which fluoroquinolones induce peripheral neuropathy is mitochondrial toxicity. The report says:

“Ciprofloxacin has been found to affect mammalian topoisomerase II, especially in mitochondria. In vitro studies in drug-treated mammalian cells found that nalidixic acid and ciprofloxacin cause a loss of motichondrial DNA (mtDNA), resulting in a decrease of mitochondrial respiration and an arrest in cell growth. Further analysis found protein-linked double-stranded DNA breaks in the mtDNA from ciprofloxacin-treated cells, suggesting that ciprofloxacin was targeting topoisomerase II activity in the mitochondria.”

Conclusion

I really do appreciate the research described in Feet First? Old Mitochondria Might Be Responsible For Neuropathy In The Extremities.  Experiments, analysis and scientific documentation are needed.  But synthesis of existing information is needed too.

Drugs that deplete mitochondrial DNA are leading to peripheral neuropathy.  Perhaps the Johns Hopkins study is the piece of the puzzle that is missing from widespread recognition of this.

We shall see.

Floxie Hope Podcast Episode 21 – James

James is featured in Episode 21 of The Floxie Hope Podcast.

Check it out:

https://itunes.apple.com/us/podcast/floxie-hope-podcast/id945226010

http://www.floxiehopepodcast.com/episode-021-james/

James also shared his story in writing, and you can read it here – https://floxiehope.com/james-story-hurt-by-metronidazole-then-cipro/. He goes into more detail in the podcast though, and I highly recommend that you listen in. Thank you for sharing your story, James!

James was 24 years old when he was floxed. He lost his grip strength after taking a single pill. After that, he experienced pain, burning pain in his legs, his eyes hurt, he had floaters in his vision, visual snow, loss of ability to sweat, weight loss, stiff and weak legs, nerve pain, brain fog, and anxiety.

He was acutely sick for 9 months. Even though he has recovered to the point where he is able to do his job again, he is not quite at 100% yet. He’s getting there though. He has a new perspective on health, healing, and happiness that is helping him immensely.

Thank you for listening to James’ insightful and uplifting story!

(Again, I apologize about the sound quality. There is still a lot of beneficial information in the podcast, despite the static and echoes.)

 

A Fluoroquinolone Toxicity Post Goes Viral

A post about fluoroquinolone toxicity, i.e. getting “floxed,” i.e. getting “ruined” by Cipro, has gone viral.

Check it out!

This antibiotic will ruin you.

It has been shared more than 10,000 times on Facebook (probably closer to 20,000 – the web site stops updating each share after 10,000 shares) – including more than 6,000 shares from The Fluoroquinolone Wall of Pain Facebook page.

It is resonating with thousands of people, who are not only reading it, they are sharing it. It has been viewed by MILLIONS of people. The author, Amy, posted on her facebook page that, in just a couple days, the post has been viewed more than 4 million times. That’s amazing!

Please shareThis antibiotic will ruin you with your friends and family. It’s getting through to people. It’s informing people. It’s connecting people.

Thank you, Amy, for sharing your journey and your story, and for doing it in a way that has resonated with so many people!

This post has done more to get the word out about the dangers of fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin, and a few others) than 90% of the other posts, media stories, etc. that have been produced. It has gone viral. It has gone so viral that people are writing about it going viral, including WOMAN SAYS FLOUROQUINOLONES ANTIBIOTICS ‘WILL RUIN YOU,’ GETS 40K FACEBOOK LIKES on Inquistr.com (which, I believe is part of Buzzfeed), and, obviously, this post.

Viral posts aren’t something that happens every day, so, CONGRATULATIONS, Amy! Most importantly, her viral post, This antibiotic will ruin you, is increasing awareness about fluoroquinolone toxicity.

This antibiotic will ruin you has more than 1,000 comments on it – many of which are from fellow “floxies.” Amy has stated (on facebook) that she wants to respond to all of them, but that she’s drowning in the volume of comments. Can you, my friends in the “floxie” community, who are experts in fluoroquinolone toxicity, please help her? Please take some time to respond to some of the people who have commented on This antibiotic will ruin you. Your help will be appreciated!

The viral nature of the post has given us a window of opportunity to inform people about fluoroquinolone toxicity, and to support those who are going through it who didn’t realize that there is a support network available. Any help that you can provide in further spreading the post, and helping to answer comments on the post, will help. Thank you!

 

 

EMA to review persistence of side effects known to occur with quinolone and fluoroquinolone antibiotics

I hope I’m not too late in posting this. The following notice was published by the European Medicines Agency (EMA) in February, 2017 (and I’m posting it in March). I want to encourage all of my European “floxie” friends to contact the EMA to report your reaction, and to inquire about testifying. Even if testifying isn’t a possibility, we should all pay attention to what the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) decides.

The contact person listed on the EMA notice is:

Monika Benstetter
Tel. +44 (0)20 3660 8427
E-mail: press@ema.europa.eu

HOWEVER, the EMA has given us the contact information for the UK representatives of PRAC (the EMA’s Pharmacovigilance Risk Assessment Committee). Please contact them instead. They are:

julie.williams@mhra.gsi.gov.uk
and
patrick.batty@mhra.gsi.gov.uk

European floxie friends, please reach out to Ms. Benstetter to share your story, or to find out who you should share your story with. The patient testimony at the FDA hearing was moving, powerful, and I believe that it made a difference. Hopefully patient testimony will be allowed by the EMA, and it will make a difference too.

Here is the EMA announcement:

EMA to review persistence of side effects known to occur with quinolone and fluoroquinolone antibiotics: Review to focus on long-lasting effects mainly affecting musculoskeletal and nervous systems

The European Medicines Agency (EMA) is reviewing systemic and inhaled quinolone and fluoroquinolone antibiotics to evaluate the persistence of serious side effects mainly affecting muscles, joints and the nervous system. These side effects are of particular importance when the medicines are used for less severe infections.

The review is at the request of the German medicines authority (BfArM) following reports of longlasting side effects in the national safety database and the published literature. There has been no previous EU-wide review specifically focusing on the persistence of the side effects, but the side effects themselves are known and covered in the EU prescribing information for these medicines.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will now evaluate all available data and determine whether there is a need to introduce new measures to minimise these risks or modify how the medicines are used.

Quinolones and fluoroquinolones are widely prescribed in the EU and are important options for treating serious, life-threatening bacterial infections. Healthcare professionals using these medicines should continue to follow the official prescribing information.

Patients who have any questions about their treatment should speak to their doctor.

More about the medicines

Quinolones and fluoroquinolones are a class of broad spectrum antibiotics that are active against so-called Gram-negative and Gram-positive bacteria.

The review covers the following medicines: cinoxacin, ciprofloxacin, enoxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin, nalidixic acid, norfloxacin, ofloxacin, pefloxacin, pipemidic acid, prulifloxacin and rufloxacin.

More about the procedure

The review of quinolone and fluoroquinolone antibiotics was initiated on 9 February 2017 at the request of German medicines authority (BfArM), under Article 31 of Directive 2001/83/EC.

The review will be carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will issue recommendations. The PRAC recommendations will then be sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency’s opinion. The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.

I hope that the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) decides to acknowledge the serious adverse reactions caused by fluoroquinolones, and that they restrict the use of fluoroquinolones in Europe.

European friends, if you hear of anything that you can do to push the EMA’s PRAC to to decide to restrict fluoroquinolone use in Europe, please let me know. I’ll update this post if I hear anything new. Thank you!

 

 

 

 

Floxie Hope Podcast Episode 20 – Renee

Renee shares her journey through fluoroquinolone toxicity on Episode 20 of The Floxie Hope Podcast. Please check it out:

http://www.floxiehopepodcast.com/episode-020-renee/

https://itunes.apple.com/us/podcast/floxie-hope-podcast/id945226010

Renee’s written story of her journey through fluoroquinolone toxicity can be found here – https://floxiehope.com/renees-story-cipro-reaction/

Renee had taken fluoroquiolones in the past with no notable adverse reaction. This time though, after taking ONE PILL, the flox BOMB went off in her body and she experienced many devastating symptoms of fluoroquinolone toxicity.

Some keys to her recovery included The Wahls Protocol diet, support from loved ones, and a hopeful, positive attitude.

Thank you so much for sharing your journey, Renee! You are amazing, wise, and greatly appreciated!

 

Happy Birthday Grandma!

grandma

Today is my Grandma’s birthday. Happy birthday, Gram! I hope you have a wonderful day!

My Grandma is one of my favorite people in the world and I love her very much.

My Grandma was incredibly, wonderfully supportive through my journey through fluoroquinolone toxicity. As soon as I said, “I’m sick,” before I even knew why or how I was sick, she took me seriously. When I realized what was making me sick, she never questioned me. She never downplayed or dismissed my experience with fluoroquinolone toxicity–she just believed me. She was always on my side, and it didn’t seem like it ever occurred to her to believe the medical establishment, or anyone else, over me.

When she broke her hip a few years after I got floxed, my Grandma immediately put Cipro on her list of medications that she was not to be given. She knew that it was dangerous because of what I had gone through, and she didn’t want what happened to me to happen to her. Her refusal to take Cipro meant a lot to me. It signified that she believed me, and that she didn’t believe that my reaction was something rare or dismissible. It meant that she listened. I write about my experience with fluoroquinolone toxicity not to relive what happened, or to wallow in it, but to warn people so that they don’t go through the same thing I did. It means a lot when people listen, and it meant a lot to me that my Grandma listened to me, and that she refused to take the drug that hurt me. I’ve never had to fight with a doctor about a fluoroquinolone prescription for a loved one, but, I’m pretty sure that if I did get into an argument with a doctor about whether or not a fluoroquinolone prescription was appropriate for my Grandma, she would take my side.

I am lucky in that I have a lot of wonderfully supportive people in my life. I always felt like everyone in my family loved me and wanted what was best for me. I have always known that I am loved and cherished. I have always known that all of my loved ones were on my side. They are all appreciated!

Not all “floxies” have supportive loved ones. Some people don’t believe that their floxed loved one is really sick. Some people don’t try to understand what their floxed loved one is going through. Some people have family members who are dismissive of fluoroquinolone toxicity, and who don’t believe that it’s “real.” Some people have family members who believe that fluoroquinolones can’t be dangerous, and that adverse reactions can’t be devastating, even though there is plenty of documented evidence that fluoroquinolones ARE dangerous and adverse reactions ARE devastating. It saddens me when I hear of people who are not supported by their loved ones as they go through the difficulty of fluoroquinolone toxicity.

I appreciate the support of all my family members, and, today, on my Grandma’s birthday, I am especially appreciative of her.

You are loved, Gram. Happy Birthday! xoxo

 

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