Medicines Healthcare Products Regulatory Agency
Advice for healthcare professionals:
- systemic (by mouth, injection, or inhalation) fluoroquinolones can cause long-lasting (up to months or years), disabling, and potentially irreversible side effects, sometimes affecting multiple systems, organ classes, and senses
- despite new restrictions and precautions introduced in 2019, a new study has shown no evidence of a change in fluoroquinolone prescribing patterns in the UK, and the MHRA has continued to receive Yellow Card reports of these side effects
- advise patients to stop treatment at the first signs of a serious adverse reaction, such as tendinitis or tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy, and central nervous system effects, and to contact their doctor immediately for further advice sheet for patients
- do not prescribe fluoroquinolones:
- for non-severe or self-limiting infections, or non-bacterial conditions, for example non-bacterial (chronic) prostatitis
- for mild to moderate infections (such as in acute exacerbation of chronic bronchitis and chronic obstructive pulmonary disease) unless other antibiotics that are commonly recommended for these infections are consider inappropriate (see below)
- do not prescribe ciprofloxacin or levofloxacin for uncomplicated cystitis unless other antibiotics that are commonly recommended are considered inappropriate (see below)
- avoid fluoroquinolone use in patients who have previously had serious adverse reactions with a quinolone antibiotic (for example, nalidixic acid) or a fluoroquinolone antibiotic
- prescribe fluoroquinolones with special caution for people older than 60 years and for those with renal impairment or solid-organ transplants, because they are at a higher risk of tendon injury
- avoid use of a corticosteroid with a fluoroquinolone since coadministration could exacerbate fluoroquinolone-induced tendinitis and tendon rupture
- report suspected adverse drug reactions to fluoroquinolone antibiotics on the Yellow Card website or via the Yellow Card app (download it from the Apple App Store, or Google Play Store
Advice for healthcare professionals to give to patients and caregivers:
- fluoroquinolone antibiotics are a group of antibiotics that include ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, and ofloxacin sometimes these medicines may also have a brand name so patients should check the details of all antibiotics prescribed to them
- fluoroquinolone antibiotics have been reported to cause serious side effects involving tendons, muscles, joints, nerves, or mental health in some patients, these side effects have caused long-lasting or permanent disability
- stop taking your fluoroquinolone antibiotic and contact your doctor immediately if you have any of the following signs of a side effect:
- tendon pain or swelling if this happens, rest the painful area until you can see your doctor
- pain in your joints or swelling in your shoulders, arms, or legs
- abnormal pain or sensations (such as persistent pins and needles, tingling, tickling, numbness, or burning), weakness in your body, especially in the legs or arms, or difficulty walking
- severe tiredness, depressed mood, anxiety, or problems with your memory or severe problems sleeping
- changes in your vision, taste, smell, or hearing
- tell your doctor if you have had any of the above effects during or shortly after taking a fluoroquinolone this means you should avoid them in the future
Disabling and potentially long-lasting or irreversible side effects
Systemic and inhaled fluoroquinolones are associated with a risk of serious, disabling, long-lasting and potentially irreversible adverse reactions. These may affect different, sometimes multiple, body systems, and may include musculoskeletal, nervous, psychiatric, and sensory reactions. They have been reported in patients irrespective of their age and risk factors. Tendon damage (including the Achilles tendon but other tendons can also be involved) can occur within 48 hours of commencing treatment, or the effects can be delayed for several months and become apparent after stopping treatment. A to remind them of the risks.
There are no pharmacological treatments established to be effective for these disabling and potentially long-lasting or irreversible side effects. However, it is important that these symptoms are appropriately investigated, and that fluoroquinolones are stopped immediately at the first signs or symptoms of a serious adverse reaction to avoid further exposure, which could potentially worsen adverse reactions.
Restrictions to the use of fluoroquinolones were introduced in 2019 to minimise the risk of these reactions. Fluoroquinolones should not be prescribed for treatment of mild to moderate infections (such as in acute exacerbation of chronic bronchitis and chronic obstructive pulmonary disease) unless other antibiotics that are commonly recommended for these infections are considered inappropriate.
Relevant situations in which other antibiotics may 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
- other first-line antibiotics have caused side effects requiring treatment to be stopped
- treatment with other first-line antibiotics has failed
Further review by MHRA
After conducting a further review, the MHRA sought the advice of the Commission on Human Medicines (CHM) on existing the success of measures to minimise the risk of disabling and potentially long-lasting or irreversible side effects of fluoroquinolones. The MHRA review involved engagement with patients and patient representatives to seek their views. It also included a review of data from a new study of fluoroquinolone prescribing in 6 European countries, including the UK,[footnote 1] following the introduction of new restrictions for use, alongside data from other sources.
While the new study referenced above reported an overall decrease in the prescribing of fluoroquinolones in primary care in the UK, there was no evidence of a change in prescribing patterns as a result of the restrictions introduced in 2019. The study noted continued prescribing of fluoroquinolones in patients with risk factors for adverse reactions, such as patients who were concomitantly prescribed corticosteroids. We also continue to receive Yellow Card reports of these side effects, including reports where a fluoroquinolone was prescribed in situations where the product information includes a warning, or where a fluoroquinolone was prescribed for a mild or moderate infection and where an alternative antibiotic may have been appropriate. The CHM advised that it would be important to increase awareness of these risks among healthcare professionals.
We will communicate in due course any additional regulatory actions in the UK as a result of this review.
Report any suspected adverse drug reactions
Please continue to report suspected adverse drug reactions to fluoroquinolones via the Yellow Card Scheme. Your report will help us safeguard public health.
Healthcare professionals, patients, and caregivers are asked to submit reports using the Yellow Card scheme electronically using:
- the Yellow Card website
- the Yellow Card app; download from the Apple App Store or Google Play Store