European Medicines Agency (EMA) Warnings

---

Pharmacovigilance Risk Assessment Committee (PRAC) Meeting - Label Changes 2024:

[The  EMA did not issue a separate public news announcement or press release specifically about the 2024 fluoroquinolone label adjustment] 

Newly identified aspects of neuropsychiatric reactions should be added to the existing information under the description of selected adverse drug reactions and corresponding section in the package

leaflet to include anxiety, suicidal ideation, panic attack, neuralgia and concentration

impairment as potential aspects of fluoroquinolone induced long-lasting and disabling

adverse drug reactions.   [Quofenix (delafloxacin) and Quinsair (inhaled levofloxacin)] 

https://www.ema.europa.eu/en/documents/minutes/minutes-prac-meeting-30-september-03-october-2024_en.pdf

European Medicines Agency’s (EMA) Public Health Communication 2023:

After an EMA-funded study found that fluoroquinolones were still being prescribed outside the restricted uses, EMA sent a new EU-wide Direct Healthcare Professional Communication. It repeated that these drugs should not be used for self-limiting infections, certain mild-to-moderate infections when alternatives are appropriate, non-bacterial conditions, prevention of travellers’ diarrhea or recurrent lower UTIs, or in patients who previously experienced a serious quinolone or fluoroquinolone reaction. 

https://www.ema.europa.eu/en/news/fluoroquinolone-antibiotics-reminder-measures-reduce-risk-long-lasting-disabling-potentially-irreversible-side-effects

European Medicines Agency’s (EMA) Fluoroquinolone Press Release 2018:

Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics (implemented in 2019)

https://www.ema.europa.eu/en/news/disabling-potentially-permanent-side-effects-lead-suspension-or-restrictions-quinolone-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. 

https://www.ema.europa.eu/en/medicines/human/referrals/quinolone-fluoroquinolone-containing-medicinal-products

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.  

https://www.ema.europa.eu/en/medicines/human/referrals/quinolone-fluoroquinolone-containing-medicinal-products#all-documents