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Parliamentary questions
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24 September 2019
Question for written answer E-002942-19
to the Commission
Rule 138
Piernicola Pedicini (NI)

 Subject:  Antibiotics taken off the market
 Answer in writing 

The Italian Medicines Agency (AIFA) has published further information about the safety of medicinal substances containing fluoroquinolone (ciprofloxacin, levofloxacin, moxifloxacin, pefloxacin, prulifloxacin, rufloxacin, norfloxacin, lomefloxacin) which may produce long-lasting, disabling and potentially permanent adverse side effects, mainly affecting the tendons, muscles or joints and the nervous system.

AIFA has announced, therefore, that medicines containing cinoxacin, flumequine, nalidixic acid and pipemidic acid will be withdrawn from sale.

The German Federal Institute for Drugs and Medical Devices (BfArM) asked the European Medicines Agency (EMA) in 2017 to re-evaluate these medicines, which it did, but this was after it had already given the green light to their being marketed within the EU. In view of that fact, and the final assessments issued by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) in 2018 and its Committee for Human Medical Products (CHMP), can the Commission answer the following:
1. Which studies were examined during the marketing authorisation procedures conducted prior to the re-evaluation requested in 2017?
2. Was sufficient weight given to the permanent, disabling adverse side effects on the tendons, muscles and joints and on the nervous system when those studies were examined?
3. Is the Commission going to give patients a straightforward, unambiguous explanation of exactly which medicines will be taken off the market and when?
Original language of question: IT 
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