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Fluoroquinolone Toxicity Study, NFP

Fluoroquinolone Toxicity Study, NFPFluoroquinolone Toxicity Study, NFPFluoroquinolone Toxicity Study, NFP

European Medicines Agency (EMA) Warnings

  

European Medicines Agency’s (EMA) Fluoroquinolone Press Release 2019:

https://www.ema.europa.eu/en/documents/referral/quinolone-Fluoroquinolone-article-31-referral-disabling-potentially-permanent-side-effects-lead_en.pdf


European Medicines Agency’s (EMA) Fluoroquinolone Public Hearing 2018:

https://www.ema.europa.eu/en/documents/other/public-hearing-quinolone-Fluoroquinolone-written-interventions_en.pdf


13 patient testimonies before the EMA 2018 starting at minute 14:15

https://www.youtube.com/watch?v=1vao8o5NGUc



Pharmacovigilance Risk Assessment Committee (PRAC) Assessment Report 2018:

https://www.ema.europa.eu/en/documents/referral/quinolone-Fluoroquinolone-article-31-referral-assessment-report_en.pdf

 The following mechanisms may be supportive of a causal relationship between (fluoro) quinolones and tendon disorders: 

Tendon disorders

  • Oxidative stress (ROS overproduction)
  • Mitochondrial damage
  • Inhibition of tenocytes proliferation 
  • Inhibition of tenocytes migration
  • Enhanced expression of matrixmetalloproteinases (MMPs)
  • Induced apoptosis
  • Chelation of metal ions by quinolones
  • Ischemia and contribution of poor vascularization in tendon tissue

Neurotoxicity

Neuropathies

Phototoxicity

Vasculitis



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Interactive Drug Analysis Profile (ADR's):


Avelox:  https://info.mhra.gov.uk/drug-analysis-profiles/dap.html?drug=./UK_EXTERNAL/NONCOMBINED/UK_NON_001005786432.zip&agency=MHRA  


Levofloxacin:  https://info.mhra.gov.uk/drug-analysis-profiles/dap.html?drug=./UK_EXTERNAL/NONCOMBINED/UK_NON_000197682791.zip&agency=MHRA


Ciprofloxacin:  https://info.mhra.gov.uk/drug-analysis-profiles/dap.html?drug=.%2FUK_EXTERNAL%2FNONCOMBINED%2FUK_NON_000956188993.zip&agency=MHRA&fbclid=IwAR1UdRBrO5wPLEM-Jaaohi2Ycjh2xRm08RXAQeHYiLnTdTj8c5SommRxMAg

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