Fluoroquinolones: summary of the public hearing of 13.06.2018.
The EuropeanMedicines Agency (EMA) held the public consultation on the impact of potential adverse reactions to fluoroquinolones, a group of antibiotics commonly prescribed in the European Union (EU) (such as ciprofloxacin, ofloxacin, etc.) on June 13, 2018, giving patients, physicians, healthcare professionals, nurses, pharmacists, scientists, and any other interested parties the opportunity to share their perspectives and experiences.
In preparation for the public consultation, EMA posed three questions to speakers:
- 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 actions do you think could be taken to optimize the safe use of fluoroquinolones?
The public hearing was part of the Pharmacovigilance Risk Assessment Committee's (PRAC) reassessment of serious and prolonged or persistent adverse reactions, predominantly affecting muscles, tendons, and the nervous system. Some of these adverse event reports have affected patients who had less serious infections and who could have been treated with other antibiotics.
The main points voiced by speakers during the hearing:
- Symptoms were life-altering and far-reaching.
- Patients were given too little information about the risks.
- In general, health professionals were unaware of the range and severity of possible symptoms, with the exception of Achilles tendon damage.
The following suggestions were made at the public hearing:
- A regulatory restriction on the use of fluoroquinolones to situations where there are no alternatives.
- Improve education of health care professionals (including during medical school) about the risks of fluoroquinolones.
- Taking into account the wide-ranging symptoms of side effects, a targeted approach in the management of these patients.
- Improve communication about fluoroquinolone toxicity, including potential risk factors, and include this information in the professional and patient information leaflets.
- Promote research on how fluoroquinolone drugs cause adverse reactions, including genetic research on underlying mechanisms
The Pharmacovigilance Risk Assessment Committee will now reflect on all views expressed at the hearing, including written submissions, and consider them as part of the fluoroquinolone evaluation process. The recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP).
The public report is available here: Summary of the EMA public hearing on quinolone and fluoroquinolone antibiotics.
Announcement of the public hearing:
.
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 assessment to hear directly from the experiences of interested parties so that they can be incorporated into the committee's recommendation.
In February 2017, PRAC launched an evaluation of oral, injectable, and inhalable antibiotics from the fluoroquinolones group to assess 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 consultation 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
