What the FDA isn’t telling you about your antibiotic.

Dr. Charles Bennett submitted a petition to the FDA in 2014 , asking that Mitochondrial Toxicity be added to the FDA warning label for Fluoroquinolone antibiotics such as Cipro and Levaquin. He is a Hematological Oncologist and the director of SONAR (Southern Network on Adverse Reactions.) Sadly, before the FDA review; the scientist working on this research with Dr. Bennett at the University of South Carolina, was brutally murdered in his lab. The University of South Carolina, documented this tragic news in their newspaper. https://issuu.com/muscpr/docs/cat4-03finalwads This news proved both tragic for the university, the scientist, and all of those who have been injured by Fluoroquinolone antibiotics. Now the scientist who’d worked so hard on this research, could no longer be present to push the scientific research through the review process.

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Unfortunately as a result, in May of 2016 the FDA responded by denying his petition to add this vital information to the warning labels. https://www.pharmamedtechbi.com/~/media/Supporting%20Documents/The%20Pink%20Sheet%20DAILY/2016/May/SONAR_citizen_petition_FDA_response_05132016.pdf

 It’s not surprising that The FDA would resist adding this side effect to the Fluoroquinolone label. That could open Pandora’s box. Mitochondria are the power sources of our cells. They are organelles that keep the cells full of energy so they can carry out cellular respiration. They are essencially the building blocks by which each system of the body is able to efficiently function. When that process is damaged; every body system is affected. It’s like removing all of the stabilizing blocks, at the bottom of a Jenga tower.  As a result, damage to nearly any body system, could be attributed to ingesting a Fluoroquinolone. Where would the side effect list end? Do you think any pharmaceutical giant wants to electively face the possibility of that kind of financial fallout? We already know that former FDA Chief Margaret Hamburg, her Fortune 500 husband, and Johnson and Johnson, conspired to suppress material information to the public, on the deadly and catastrophic side effects of Levaquin. https://dailycaller.com/2016/04/21/suit-alleges-former-fda-chief-suppressed-danger-of-deadly-drug-for-sake-of-profit/ Brand name Levaquin has since been pulled from production, but generic Levofloxacin continues to be produced, and prescribed to the masses. https://www.abcactionnews.com/money/consumer/taking-action-for-you/drug-maker-halts-production-of-antibiotic-with-reported-side-effects-but-risk-remains-1

Mitochondrial toxicity due to Fluoroquinolones, is medically and scientifically documented. Research is showing that Fluoroquinolone antibiotics like Cipro, Levaquin, and Avelox, cause oxidative stress and mitochondrial dysfunction. “Evidence suggests that mitochondrial dysfunction may play a role in some of these events such as the neuropathies and issues related to muscles. It has been proposed that fluoroquinolone-mediated disruption of human topoisomerase IIα and IIβ, which are present in the mitochondria, could be contributing to these toxicities.”- Examining the Impact of Antimicrobial Fluoroquinolones on Human DNA Topoisomerase IIα and IIβ Cole A. Fief, Kristine G. Hoang, Stephen D. Phipps, Jessica L. Wallace, Joseph E. Deweese https://www.researchgate.net/publication/331289308_Examining_the_Impact_of_Antimicrobial_Fluoroquinolones_on_Human_DNA_Topoisomerase_IIa_and_IIb

This year, Dr. Bennet has again petitioned the FDA to add mitochondrial toxicity, severe psychiatric effects, and permanent disability to the existing FDA Black Box warning.  The FDA responded to ABC channel 8 and this second petition:

“The FDA is reviewing the petition and will respond directly to the petitioner. It is important that health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use. For some serious bacterial infections, including bacterial pneumonia among others, the benefits of fluoroquinolones outweigh the risks and it is appropriate for these antibacterial drugs to remain available as a therapeutic option.  More information about fluoroquinolones can be found on FDA’s web site here. “

https://www.wric.com/news/taking-action/doctor-petitions-fda-for-more-warnings-about-commonly-prescribed-medications/?fbclid=IwAR0YtBdViozuGVRiUi-GnRn8W4JIoWz_974mfNVrvu9s39WBgcd0II-DH3k

Mitochondrial disease is important to acknowledge because it further explains why so many bodily systems are damaged by Fluoroquinolone antibiotics. https://www.umdf.org/what-is-mitochondrial-disease/ Some of the worst symptoms are pulmonary toxicity, liver failure, deafness, renal failure, myopathy, cardiomyopathy, extrapyramidal symptoms, metabolic syndrome, a Reye-like syndrome, muscle wasting, rhabdomyolysis, gastrointestinal damage, hepatotoxicity, neurotoxicity cardiac effects, polyneuropathy and lactic acidosis, encephalomyopathy, anaemia, pancreatitis, and memory impairment. https://www.medsafe.govt.nz/profs/PUArticles/June2017/MitochondrialDisordersMedicinestoAvoid.htm These side effects bear a striking resemblance to the side effects already listed on the FDA’s Black Box warning label for Fluoroquinolones. That list can be found under the “Additional Information for Healthcare Professionals,” found at the bottom of the page.

 Already the FDA Black Box warning lists a seemingly endless list of side effects to multiple body systems including:

  • Tendinitis/Tendon rupture
  • Aortic aneurysm and dissection
  • Muscle pain
  • Muscle weakness
  • Joint pain
  • Joint swelling
  • Peripheral Neuropathy
  • Serious Central nervous system effects include:
    • Psychosis
    • Anxiety
    •  Insomnia
    • Depression
    • Hallucinations
    • Suicidal thoughts
    • Confusion
  • Other adverse reactions include:
    • Exacerbation of myasthenia gravis
    • Prolongation of the QT interval
    • Hypersensitivity reactions/anaphylaxis
    • Photosensitivity/phototoxicity
    • Blood glucose disturbances
    • Clostridium difficile-associated diarrhea

https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-updates-warnings-oral-and-injectable-fluoroquinolone-antibiotics

Informing ourselves about the medications we take, is our responsibility as a patient. If I go to a store, I choose what I put in my cart. If I go to a restaurant, I choose what food I put in my body, and if I go to the doctor, I need to be aware of what I injest. After 23 surgeries and a seemingly endless list of health issues from a course of Cipro in 2010; I have a daily reminder that I have to be informed to protect myself and the ones I love. I’m praying the FDA will add Mitochondrial Toxicity to the pharmaceutical warning. It’s long overdue. 

https://www.nature.com/articles/d41586-018-03267-5

https://www.europeanpharmaceuticalreview.com/news/79715/ciprofloxacin-mt-genome/

https://pubs.acs.org/doi/full/10.1021/acsomega.8b03428?fbclid=IwAR3jvkSNTr0jjwdOkV6qnDF95VJbmb7CaDz_KrWJD89Gi5jLn5GE345Qnck

https://biology.stackexchange.com/questions/69563/are-fluoroquinolone-antibiotics-cipro-levaquin-etc-chemotherapy-drugs

https://www.ncbi.nlm.nih.gov/pubmed/10553698

https://www.hindawi.com/journals/omcl/2017/8023935/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3760005/

https://academic.oup.com/nar/article/46/18/9625/5088042

https://www.sciencedirect.com/science/article/abs/pii/S0928098713004508

https://www.frontiersin.org/articles/10.3389/fmolb.2017.00074/full

https://www.manufacturingchemist.com/news/article_page/Research_warns_of_negative_antibiotic_effect_on_mitochondria_in_humans/147658

https://www.sciencedaily.com/releases/2018/10/181001101943.htm

https://www.ncbi.nlm.nih.gov/pubmed/26955658

https://www.aboutlawsuits.com/levaquin-mitochondrial-toxicity-warning-petition-68138/

https://www.abcactionnews.com/money/consumer/taking-action-for-you/medical-expert-petitions-fda-for-checks-on-popular-antibiotic-to-protect-public-from-suicide-risk

http://www.myquinstory.info/dr-bennett-publishes-paper-on-fluoroquinolone-neuropsychiatric-mitochondrial-toxicity/

 

 

 


5 thoughts on “What the FDA isn’t telling you about your antibiotic.

  1. Thanks for keeping people informed and for advocating against Fluoroquinolones. You continue to help me through my toxicity. I hope this won’t happen to others because of our loud mouths 😉.

    Like

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