Email an die EMA am 2.5.2023

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Subject: Serious danger to tens of millions of patients in Europe following large-scale non-compliance with restrictions on the use of antibiotic of the fluoroquinolones family

Madam Emer Cooke, Executive Director of EMA,
Madam Sabine Straus, Chairman of the EMA’s PRAC,
Sir Martin Huber, Vice-Chairman of the EMA’s PRAC,

Related to the ongoing review, please consider the added 2 links, studies, that fluoroquinolone drops - eyes and ears- do same harm as tablets and IV forms.

During the 2018 review this has been missed, saying, that Bfarm did complain only for tablets and IV, not for drops.

Just following a simple principle of "first time right" as studies are available and avoiding further patient damages in the upcoming years - "precaution principle", please consider restricting the drops as well during the review You do nowadays..

Beyond damaging adults and kids, fluoroquinolone drops are given as first choice, on the erroneous idea that other formula are outdated ( Tobramycin, Polimyxin, etc), fluoroquinoles drops are used in preterm newborn baby centers AS EYEWASH, the eventual sight problems are recognized much later. Drops are used for babies in treatment of upper and lower respiratory infections due to better dosage as tablets, instead of tablets. In sum, restriction of drops is needed as well.

Overall, the restriction from 2019 did NO CHANGE in the Hungarian prescription habits and NO CHANGE in the hospital antibiotic use where fluoroquinolone are freely given as first choice.

Still, when talking about Fluoroquinolone damage, patients are belittled in doctors office and pharmacies as well and are sent to psychiatry.

In case of tablets and IV, during the 2018 review we had several discussions about the PERMANENT MITOCHONDRIAL DAMAGE caused by fluroquinolones, aknowledged by prof. Tulkens - researcher and developer of fluoroquinolones during the hearing, still mitochondrial damage was not inserted in the doctors and patients Drug information leaflet. As a consequence in case of adverse effects mitochondrial damage is not checked, not considered, patients are sent instead to psychiatry.

The 2018 restriction dit not bring the expected results, so was unsuccessful, more strict restrictions are needed.

https://www.sciencedirect.com/science/a ... 4l59NRt1MQ

https://ufhealth.org/news/2022/uf-healt ... VTDOw8myCs

Thank you for consideration!

Best Regards