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

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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 starting at minute 14:15

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

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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

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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