During its May 2023 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), is reminding healthcare professionals that the use of fluoroquinolone antibiotics given by mouth, injection or inhalation, is restricted due to the risk of disabling, long-lasting and potentially irreversible side effects. The PRAC discussed direct healthcare professional communications (DHPCs) containing important information on fluoroquinolone antibiotics and Gavreto.
Fluoroquinolone antibiotics: reminder of measures to reduce the risk of long-lasting, disabling and potentially irreversible side effects
The PRAC of the EMA is reminding healthcare professionals that the use of fluoroquinolone antibiotics given by mouth, injection or inhalation, is restricted due to the risk of disabling, long-lasting and potentially irreversible side effects.
These restrictions were introduced in 2019 following an EU-wide review of these very rare but serious side effects. The EMA-funded study “Impact of European Union Label Changes for Fluoroquinolone Containing Medicinal Products for Systemic and Inhalation Use” has shown that although the use of fluoroquinolone antibiotics has reduced, these medicines may still be prescribed outside of their recommended uses.
Restrictions on the use of fluoroquinolone antibiotics mean that they should not be used:
- to treat infections that might get better without treatment or are not severe (such as throat infections);
- to treat non-bacterial infections, e.g. non-bacterial (chronic) prostatitis;
- for preventing traveller’s diarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder);
- to treat mild or moderate bacterial infections unless other antibacterial medicines commonly recommended for these infections cannot be used.
The study which evaluated data from the primary care setting in six European countries (Belgium, France, Germany, the Netherlands, Spain and the United Kingdom) between 2016 and 2021, suggests that the measures taken to restrict the use of these medicines as a result of the EU-wide review had a modest impact.
The content of a DHPC is described in the section ‘New safety information for healthcare professionals’.
In Belgium, medicinal products containing fluoroquinolones are available under the following commercial names.
- Ciprofloxacin containing medicinal products : Ciprofloxacine AB, Ciprofloxacine EG, Ciprofloxacine Fresenius Kabi, Ciprofloxacine Mylan, Ciprofloxacine Sandoz, Ciprofloxacine Teva, Ciproxine.
- Levofloxacin containing medicinal products : Levofloxacin AB, Levofloxacine EG, Levofloxacine Fresenius Kabi, Levofloxacine Mylan, Levofloxacine Sandoz, Tavanic.
- Moxifloxacin containing medicinal products : Avelox, Moxifloxacin AB, Moxifloxacine EG, Moxifloxacine Fresenius Kabi, Moxifloxacine Teva, Moxifloxacine Sandoz.
- Ofloxacin containing medicinal products : Ofloxacine EG, Tarivid.
More information on the review is available on the EMA website.
New safety information for healthcare professionals
As part of its advice on safety-related aspects to other EMA committees, the PRAC discussed DHPCs containing important information on fluoroquinolone antibiotics and Gavreto.
Fluoroquinolone antibiotics: reminder of measures to reduce the risk of long-lasting, disabling and potentially irreversible side effects
This DHPC reminds healthcare professionals that the use of fluoroquinolone antibiotics should be restricted to a last-line treatment in patients who have no alternative therapeutic options and only after a careful assessment of the benefits and risks for individual patients. The DHPC also reminds healthcare professionals to advise patients of the risk of serious adverse reactions with fluoroquinolone antibiotics as well as of the potential long-lasting and serious nature of these effects.
Patients should immediately contact a physician at the first signs of these serious adverse reactions prior to continuing treatment. Special caution should be taken in patients who concurrently are treated with corticosteroids, in older adults, patients with renal impairment and patients who have undergone solid organ transplants, as the risk of fluoroquinolone-induced tendinitis and tendon rupture may be exacerbated in these patients.
Gavreto: measures to minimise increased risk for tuberculosis
This DHPC aims to inform healthcare professionals of the increased risk of tuberculosis and measures to minimise this risk, which was identified following a post-marketing review.
In the EU, Gavreto (pralsetinib) is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.
Tuberculosis, mostly extrapulmonary, has been reported in patients receiving this medicine. An investigation of global safety data for Gavreto identified nine cases of tuberculosis in patients, of which the majority (7/9) occurred in tuberculosis-endemic regions.
Before starting treatment, patients should be evaluated for active and inactive (latent) tuberculosis, as per local recommendations. In patients with active or latent tuberculosis, standard antimycobacterial therapy should be initiated before treatment with Gavreto is started.
Gavreto is authorised and marketed in Belgium.
More information is available on the EMA website.