European Medicines Agency (EMA) Warnings

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Revised prescribing alert January 2024

https://www.gov.uk/government/news/mhra-introduces-new-restrictions-for-fluoroquinolone-antibiotics

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

Summary -

https://www.ema.europa.eu/en/documents/report/summary-ema-public-hearing-quinolone-fluoroquinolone-antibiotics_en.pdf 

 Main points raised -
• Symptoms were life-changing and wide ranging.
• Patients were not given information about risks.
• Healthcare professionals were generally unaware of the range and severity of possible symptoms,
with the exception of Achilles tendon disorders 

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