In accordance with paragraph 8 of Section IV of the Procedure for Expert Evaluation, the applicant must amend the instructions for medical use of the medicinal product upon receipt of new data, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and ensure that the information on the medicinal product corresponds to current scientific knowledge.
The European Medicines Agency (EMA) has published the minutes of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of September 30 – October 3, 2024. Following the meeting, a decision was made on the need to introduce safety-related changes to the registration materials/package leaflets of medicinal products of the fluoroquinolone class for systemic and inhalation use: ciprofloxacin; levofloxacin; lomefloxacin; moxifloxacin; norfloxacin; ofloxacin; pefloxacin; prulifloxacin; rufloxacin.
Levofloxacin (levofloxacin) – QUINSAIR – EMEA/H/C/002789/LEG 006.1
Following the Article 31 referral procedure completed in November 2018, and after evaluation of the Periodic Safety Update Report (PSUR) for the above-mentioned medicinal product, PRAC asked the marketing authorization holder (MAH) to provide additional data on long-lasting, potentially irreversible, serious suspected adverse reactions to fluoroquinolones. The responses were assessed by PRAC in order to provide further recommendations. For additional information, see the minutes of the PRAC meeting of June 2024.
Summary of recommendations and conclusions
- Based on the analysis of the available information, PRAC confirmed the position adopted at the meeting in June 2024, and considers that, despite the limited available evidence, information on newly identified aspects of neuropsychiatric reactions should be added to the existing information in the "Adverse reactions" section of the instructions for medical use under "Description of selected adverse reactions", including anxiety, suicidal thoughts, panic attacks, neuralgia and impaired concentration as potential aspects of long-lasting and disabling adverse reactions induced by fluoroquinolones.
Fluoroquinolones for systemic and inhalation use: ciprofloxacin; levofloxacin; lomefloxacin; moxifloxacin; norfloxacin; ofloxacin; pefloxacin; prulifloxacin; rufloxacin – CZ/H/PSUFU/A31/1452/202210
PRAC advice on the follow-up procedure of the PRAC regarding risk minimization measures following the submission of cumulative reviews of spontaneously reported cases of long-lasting, potentially irreversible, serious suspected adverse reactions to medicinal products, in accordance with the results of the referral procedure under Article 31 of Directive 2001/83/EC (EMEA/H/A-31/1452), completed in 2019, at the request of the Czech Republic (follow-up of the implementation of the recommendations adopted by the PRAC in June 2024).
Summary of recommendations
- Based on the analysis of the available information, PRAC confirmed the position adopted at the meeting in June 2024, and considers that, despite the limited available evidence, information on newly identified aspects of neuropsychiatric reactions should be added to the existing information in the "Adverse reactions" section of the instructions for medical use under "Description of selected adverse reactions", including anxiety, suicidal thoughts, panic attacks, neuralgia and impaired concentration as potential aspects of long-lasting and disabling adverse reactions induced by fluoroquinolones.
Changes to the safety information of fluoroquinolone-class medicinal products for systemic and inhalation use following the meeting of the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) of October 15-16, 2024
Fluoroquinolones for systemic and inhalational use – CZ/H/PSUFU/A31/1452/202210 / CZ
PSUSA follow-up procedures [PSUSA Follow-up procedures (PSUFU)]
The CMDh endorsed the results of the “non-standard” PSUFU procedure for fluoroquinolones for systemic and inhaled use.
Based on the review, taking into account the available data on anxiety, panic attacks, suicidal thoughts, neuralgia and impaired concentration, an update of the existing information in the “Adverse Reactions” section of the instruction for medical use (under the description of “selected adverse reactions”) was agreed, adding new aspects regarding long-lasting, disabling and potentially irreversible adverse reactions.
All marketing authorization holders of the relevant medicinal products must update the instructions for medical use in accordance with the recommendations.
List of medicinal products containing ciprofloxacin; levofloxacin; lomefloxacin; moxifloxacin; norfloxacin; ofloxacin and approved for medical use in Ukraine (according to the State Register of Medicinal Products as of 15.01.2025).
TO SUBMIT THE CORRESPONDING APPLICATION FOR AMENDMENTS TO THE REGISTRATION MATERIALS, THE APPLICANT MUST USE THE ORIGINAL TEXT POSTED AT THE LINKS, FOR ANALYSIS OF THE PUBLISHED INFORMATION:
