European Medicines Agency (EMA) announces that its safety committee, Pharmacovigilance Risk Assessment Committee (PRAC), 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 European Union (EU)-wide review of these very rare, but serious side effects. An EMA funded study 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.
Importantly, fluoroquinolones should be avoided in patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic. They should be used with special caution in the elderly, patients with kidney disease and in those who have had an organ transplantation because these patients are at a higher risk of tendon injury. Since the use of a corticosteroid with a fluoroquinolone also increases this risk, combined use of these medicines should be avoided.
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.
A direct healthcare professional communication (DHPC) will now be sent to healthcare professionals in the EU. The DHPC will emphasize the need to limit the use of these medicines 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.
Information for healthcare professionals:
- Findings of a study commissioned by EMA (EUPAS37856) suggest that fluoroquinolones continue to be prescribed outside of their recommended uses.
- EMA also notes that the study was subject to limitations and that caution should therefore be used when interpreting its data.
- Healthcare professionals are reminded of the outcome of an EU-wide review of inhaled and systemic quinolone and fluoroquinolone antibiotics that was conducted in 2018 by EMA. This review led to significant restrictions on the use of these medicines due to the risk of rare but long-lasting (up to months or years), serious, disabling and potentially irreversible adverse reactions affecting different, sometimes multiple, body systems (musculoskeletal, nervous, psychiatric and senses).
- These adverse reactions can be limited by restricting the use of fluoroquinolones 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.
- Particular caution should be taken when prescribing fluoroquinolones in older patients, those with renal impairment, solid organ transplantation or on systemic corticosteroids as the risk of some adverse reactions (e.g. tendonitis, tendon rupture) are higher in these patients. Concomitant treatment with a fluoroquinolone and a corticosteroid should be avoided.
- Patients should be informed of the risks associated with fluoroquinolones prior to initiating treatment, including the potentially long-lasting and serious nature of these side effects, and advised to stop treatment and speak with their doctor at the first signs or symptoms of these adverse reactions.
- Fluoroquinolone treatment should be discontinued, and alternative treatment should be considered at the first sign of tendon pain or inflammation or of symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness, so as to prevent development of potentially irreversible adverse reactions.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/fluoroquinolone-antibiotics-reminder-measures-reduce-risk-long-lasting-disabling-potentially
In Hong Kong, there are registered pharmaceutical products containing systemic fluoroquinolones for use in human, including ciprofloxacin (53 products), levofloxacin (47 products), moxifloxacin (7 products), norfloxacin (3 products), ofloxacin (15 products) and prulifloxacin (one product). All products are prescription-only medicines.
So far, the Department of Health (DH) has received adverse drug reaction related to ciprofloxacin (one case), levofloxacin (12 cases; of which 3 cases were related to tendinitis and/or neuropathy), moxifloxacin (one case) and ofloxacin (4 cases; all cases were related to suicide/suicide attempt). The DH has not received any case of adverse drug reaction related to norfloxacin and prulifloxacin.
Related news on the risk of musculoskeletal, nervous and psychiatric adverse reactions associated with the use of fluoroquinolones was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 8 Nov 2011, with the latest update posted on 27 Feb 2020. Letters to inform local healthcare professionals of the relevant safety information were issued on 8 Nov 2011, 16 Aug 2013, 13 May 2016, 11 Jul 2018 and 8 Oct 2018.
In Jun 2019, the Registration Committee of the Pharmacy and Poisons Board discussed the matter, and decided that the sales pack labels and/or package inserts of locally registered pharmaceutical products containing fluoroquinolones for systemic use should contain safety information about the risk of disabling and potentially irreversible serious adverse reactions (including tendinitis and tendon rupture, peripheral neuropathy and central nervous system effects). The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities.
Ends/Saturday, May 13, 2023
Issued at HKT 13:00
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