Tighter controls are to be placed on quinolone antibiotics from 2019, after the European Medicines Agency called for certain medicines containing this class of antibiotics to be suspended, and for others to be restricted.
The EMA launched a review into the class of broad spectrum antibiotics earlier in 2018, following reports of ‘serious, disabling and potentially permanent side effects’.
In response, the UK’s Medicines and Healthcare products Regulatory Agency said it will put the changes into effect once they are finalised by the European Commission in early 2019.
The EMA review incorporated views from patients, healthcare professionals and academics – all of which were presented at EMA’s public hearing in June 2018.
It covered medicines containing the following fluoroquinolone and quinolone antibiotics: cinoxacin, ciprofloxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin, nalidixic acid, norfloxacin, ofloxacin, pefloxacin, pipemidic acid, prulifloxacin and rufloxacin.
In a statement released earlier this month, the EMA said it ‘has reviewed serious, disabling and potentially permanent side effects with quinolone and fluoroquinolone antibiotics given by mouth, injection or inhalation‘.
It added: ‘EMA’s human medicines committee (CHMP) has endorsed the recommendations of EMA’s safety committee (PRAC) and concluded that the marketing authorisation of medicines containing cinoxacin, flumequine, nalidixic acid, and pipemidic acid should be suspended. The CHMP confirmed that the use of the remaining fluoroquinolone antibiotics should be restricted.’
The EMA said that restrictions on the remaining fluoroquinolone antibiotics will mean that they should not be used to treat infections that might get better without treatment or are not severe, or for recurring lower urinary tract infections.
They should ‘generally be avoided in patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic’ or those taking a corticosteroid, and used with ‘special caution in the elderly, patients with kidney disease and those who have had an organ transplantation’, the regulatory body added.
Following the calls for restrictions, an MHRA spokesperson said: ‘MHRA has taken part in the ongoing EU review of the disabling and potentially long-lasting side effects reported with these medicines.
‘The PRAC recommended restricting the use of fluoroquinolone antibiotics. These recommendations are now subject to further EU consideration and will take effect once a European Commission decision is issued.’
It added: ‘Once the decision is finalised in early 2019, the licences in the UK will be updated and we will communicate the new advice to healthcare professionals and patients.’
A version of this article was originally published by our sister publication Pulse.
