European Medicines Agency (EMA) Warnings
European Medicines Agency’s (EMA) Fluoroquinolone Press Release 2019:
Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics
European Medicines Agency’s (EMA) Fluoroquinolone Public Hearing 2018:
The EMA Public Hearing on quinolone and fluoroquinolone antibiotics highlighted patient reports of life-changing, wide-ranging symptoms; lack of adequate patient warnings; and limited healthcare professional awareness of the range and severity of reactions beyond better-known tendon injuries. EMA later stated that its review incorporated views from patients, healthcare professionals, and academics presented at the hearing, contributing to the subsequent restrictions and risk-minimisation measures.
Pharmacovigilance Risk Assessment Committee (PRAC). Quinolone and fluoroquinolone Article-31 referral - Assessment report. EMA/818158/2018. Adopted October 16, 2018; first published March 19, 2019. Available through EMA’s referral document list
The PRAC Assessment Report discussed non-clinical evidence and possible mechanisms that may support a causal relationship between fluoroquinolones and tendon disorders, including oxidative stress/ROS overproduction, mitochondrial damage, inhibition of tenocyte proliferation, inhibition of tenocyte migration, enhanced expression of matrix metalloproteinases, induced apoptosis, chelation of metal ions by quinolones, and ischemia or poor vascularization in tendon tissue.
The PRAC Assessment Report also reviewed non-clinical evidence and proposed mechanisms for other fluoroquinolone-associated adverse effects, including neurotoxicity, neuropathies, phototoxicity, and vasculitis.
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