Medicines Healthcare Products Regulatory Agency
From today, fluoroquinolone antibiotics given systemically (by mouth, injection, or inhalation) must only be administered when no other antibiotics are appropriate for use, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced. This means that fluoroquinolones should only be prescribed when other recommended antibiotics have failed, will not work due to resistance, or are unsafe to use in an individual patient.
This is a strengthening of the previous regulations which stated that fluoroquinolones should not be prescribed for mild to moderate or self-limiting infections, or non-bacterial conditions.
The MHRA conducted a thorough review into the effectiveness of current measures to reduce the risk of potentially long-term adverse reactions to fluoroquinolone antibiotics and sought advice from the Commission on Human Medicines (CHM). The review process considered available evidence, including Yellow Card reports submitted by patients and healthcare professionals, and the experiences of people affected by these side effects.
The restrictions have been introduced following Yellow Card reports from patients who have experienced long-lasting or disabling reactions following use of fluoroquinolones, in some cases prescribed for mild to moderate or self-limiting infections, or non-bacterial conditions.
The MHRA is committed to listening to patient voices and continuously reviews data to improve patient safety.
Dr Alison Cave, MHRA Chief Safety Officer, said:
Patient safety is our top priority. We have listened to the experience of patients regarding long-lasting and potentially irreversible adverse reactions following use of fluoroquinolone antibiotics, in some cases prescribed for mild-to-moderate infections. We recognise fully the importance of limiting the use of these medicines.
Thats why, from today, fluoroquinolones should only be prescribed when usage of other antibiotics is inappropriate. Fluoroquinolones use should be discontinued at the first signs of a serious adverse reaction.
Patients using fluoroquinolone antibiotics should carefully read the advice in the patient information leaflet about possible adverse reactions and seek immediate medical advice if they experience any side effects involving symptoms relating to tendons, muscles, joints, nerves or mental health at any point during treatment. Please continue to report any suspected adverse reactions to fluoroquinolonesvia the Yellow Card scheme.
Notes to Editors
- Please see the MHRAs recent Drug Safety Update for further information.
- Healthcare professionals are reminded to remain alert to the risk of suicidal thoughts and behaviours with use of fluoroquinolone antibiotics. A reminder about these risks was published in September 2023.
- The new restrictions state that fluoroquinolone antibiotics must only be prescribed when other antibiotics that are commonly recommended for the infection are inappropriate. This applies to all indications listed below. Situations where other antibiotics are considered to be inappropriate are where:
- there is resistance to other first-line antibiotics recommended for the infection;
- other first-line antibiotics are contraindicated in an individual patient;
- other first-line antibiotics have caused side effects requiring treatment to be stopped;
- treatment with other first-line antibiotics has failed.
- Serious adverse reactions to fluoroquinolone antibiotics include tendinitis or tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy and central nervous system effects. A list of potential side effects is provided in the summary of product characteristics (SmPC) and patient information leaflet (PIL) for these medicines.
- When reporting to the Yellow Card scheme, please provide as much information as possible, including information about batch numbers, medical history, any concomitant medication, onset timing, treatment dates and p