The European Medicines Agency (EMA) has published a Direct Healthcare Professional Communication (DHPC) containing important information for healthcare professionals who prescribe antibacterial agents of the fluoroquinolone class for systemic and inhaled use.
Dear healthcare professional!
The registration certificate holder, in agreement with the European Medicines Agency (EMA) and [National Competent Authority], informs you of the following:
Summary
- Data from recent studies indicate that antibacterial agents of the fluoroquinolone class continue to be prescribed outside the recommended use.
- Fluoroquinolones for systemic and inhalation use should NOT be prescribed:
- patients who have previously had serious adverse reactions when using antibacterial agents of the quinolone or fluoroquinolone group;
- in non-severe or self-limiting infections (such as pharyngitis, tonsillitis and acute bronchitis);
- in mild to moderate infections (including uncomplicated cystitis, exacerbations of chronic bronchitis and chronic obstructive pulmonary disease (COPD), acute bacterial rhinosinusitis, and acute otitis media), when other antibacterial agents usually recommended for these infections are considered inappropriate;
- in non-bacterial infections, for example, non-bacterial (chronic) prostatitis;
- for the prevention of travelers' diarrhea or recurrent lower urinary tract infections.
- Fluoroquinolones for systemic and inhalation use are associated with very rare, serious, disabling, long-lasting, and potentially irreversible adverse reactions. These antibacterial agents should be prescribed only for approved indications and after careful assessment of the benefits and risks for the individual patient.
Background to the safety issue
EMA issued strong recommendations on restricting the use of systemic and inhaled fluoroquinolones following a Europe-wide review conducted in 2018 to assess the risk of serious and long-lasting (lasting months or years), disabling and potentially irreversible adverse reactions mainly affecting the musculoskeletal and nervous systems. As a result of the review conducted by EMA, the use of antibacterial agents belonging to the fluoroquinolone class was substantially restricted in 2019.
These serious adverse reactions may include tendinitis, tendon rupture, arthralgia, pain in the extremities, gait disturbance, neuropathies associated with paresthesia, depression, fatigue, memory impairment, hallucinations, psychosis, sleep disorders and impairment of the senses (hearing, vision, taste and smell). Tendon damage (especially of the Achilles tendon, but other tendons may also be involved) may occur within 48 hours after the start of treatment, or the effects may appear several months after treatment has been discontinued.
A study funded by the EMA was conducted ["Impact of changes in the labelling of antibacterial agents containing fluoroquinolones for systemic and inhaled use in the European Union" (EUPAS37856)], based on an analysis of fluoroquinolone prescription rates in six European healthcare databases (from Belgium, France, Germany, the Netherlands, Spain and the United Kingdom).
The study suggests that fluoroquinolones may still be used outside the approved indications. However, due to the limitations of the study, no definitive conclusions can be drawn.
- Health care professionals should counsel patients:
- about the risk of serious adverse reactions;
- about the potential long-term and serious nature of the reactions;
- seek immediate medical advice at the first signs of serious adverse reactions before continuing treatment.
- With particular caution it should be prescribed to patients who are concurrently using corticosteroids, elderly patients, patients with renal impairment, and patients who have undergone solid organ transplantation, since the risk of fluoroquinolone-induced tendinitis and tendon rupture may be increased in these patients.
Call to report
Healthcare professionals are encouraged to report adverse reactions in patients taking antibacterial agents of the fluoroquinolone class to the [National Competent Authority] <In accordance with the requirements of the Pharmacovigilance Procedure approved by order of the Ministry of Health of Ukraine of December 27, 2006 No. 898, registered with the Ministry of Justice of Ukraine on January 29, 2007 under No. 73/13340, all suspected adverse reactions should be reported to the State Expert Center of the Ministry of Health of Ukraine via the link: https://aisf.dec.gov.ua/>
DHPC recipients
Healthcare professionals who prescribe treatment (family doctors, otolaryngologists, pulmonologists, urologists, gynecologists, intensive care specialists, surgeons, dermatologists, ophthalmologists, neurologists, orthopedists, dentists, especially periodontists, infectious disease specialists), pharmacists, professional societies, national associations.
The full (original) text of the communication to healthcare professionals regarding the safety of use of medicinal products belonging to the class of fluoroquinolones for systemic and inhalation use can be found at the link:
