Fluoroquinolones: public hearing on 13.06.2018
The EuropeanMedicines Agency (EMA) has launched registration for the public consultation. The consultation will take place on 13/06/2018 at the EMA premises. It will be an opportunity for patients, physicians, healthcare professionals, nurses, pharmacists, scientists, and any other interested parties to share their views and experiences with fluoroquinolones, a group of antibiotics commonly prescribed in the European Union (EU) (such as ciprofloxacin, ofloxacin, etc.).
The public hearing is part of the Pharmacovigilance Risk Assessment Committee's (PRAC) re-evaluation of serious and prolonged or persistent adverse reactions that predominantly affect muscles, tendons, and the nervous system. Some of these adverse reaction reports have affected patients who had less serious infections and who could have been treated with other antibiotics.
During the consultation, the EMA wants to hear from the public about how the risks of this group of antibiotics are viewed and whether further action can be taken to ensure that these antibiotics are used as safely as possible in the future.
The public consultation offers EU citizens the opportunity to participate in this reassessment. Their experiences and assessments will complement the available scientific evidence and enrich the PRAC's discussions. Public hearings serve the purpose of increasing patient and health professional involvement in decision-making.
Those individuals who wish to participate in the public hearing as speakers or observers may contact the EMA via registration form by April 30, 2018.
In preparation for the public hearing, EMA will ask speakers three questions:
- What do you think is the role of fluoroquinolones in the treatment of infections?
- How do you assess the risks associated with fluoroquinolones?
- What further measures do you think could be taken to optimize the safe use of fluoroquinolones?
The EMA will review the applications - speakers will be selected based on their experience with fluoroquinolones and will be required to answer the PRAC's questions. EMA will further try to cover a wide range of representatives of interested parties as well as to include as many people as possible. For those unable to attend the EMA itself, the hearing will be broadcast live via the EMA website.
Practical information about EMA's public hearings is available in a video and in guidance for public participants: Public hearing guidance for public participants
This explains what to expect from a public hearing, how to register, and how EMA selects speakers.
If more information is needed, interested members of the public can request information by emailing publichearings@ema.europa.eu.Background on the public hearing on quinolone and fluoroquinolone
Antibiotics
The Pharmacovigilance Risk Assessment Committee (PRAC) decided to organize a public hearing as part of the fluoroquinolone evaluation to hear directly from the experiences of interested parties so that they can be included in the committee's recommendation.
In February 2017, the PRAC launched an assessment of oral, injectable, and inhalable antibiotics from the fluoroquinolones group to evaluate the persistence of rare serious adverse reactions, mainly affecting muscles, joints, and the nervous system, some of which may be of long duration. During the course of the evaluation, the EMA has observed a growing public interest in the safety of these drugs. Given this increased interest, the PRAC believes it would be useful to hold a hearing to gain a better understanding of the public's views on the risks associated with the use of these antibiotics and the feasibility of certain measures to optimize safe use.
Launch of the safety trial
The EuropeanMedicines Agency (EMA) has launched a process in its Pharmacovigilance Risk Assessment Committee (PRAC) to scientifically re-evaluate antibiotics from the fluoroquinolone group for the persistence of serious adverse reactions. These side effects are of particular concern when the drugs are used for less severe infections.
The process was started because of reports of long-lasting side effects. Until now, there has been no EU-wide assessment specifically addressing the persistence of these side effects. The procedure will now evaluate all available data and decide whether new risk minimization measures or changes in the use of these drugs are needed.
Fluoroquinolones are widely prescribed in the EU and are important treatment options for serious, life-threatening bacterial infections. Physicians are advised to continue using these medicines as described in the SmPC. Fluoroquinolones are a class of broad-spectrum antibiotics that are effective against Gram-negative and Gram-positive bacteria. The evaluation process includes the following agents: cinoxacin, ciprofloxacin, enoxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin,nalidixic acid, norfloxacin, ofloxacin, pefloxacin, pipemidic acid, prulifloxacin, and rufloxacin.
The evaluation concerns only inhaled and systemically applied drugs (orally or by injection). Topical applications applied directly to the skin, eyes, or ears are not included in the evaluation.
Patients who have questions during the ongoing risk assessment process should contact their physician or pharmacist. Details of the process can be found at the following link from the European Medicines Agency (EMA): Quinolones and fluoroquinolones containing medicinal products.
Queries (technical)
Dr. Christoph Baumgärtel, Tel.: 050555/36004
E-mail: christoph.baumgaertel@ages.at
Inquiries (for media)Communications Management AGES/BASG
E-mail: presse-basg@basg.gv.at
