Medicines and Healthcare products Regulatory Agency (MHRA) announces that healthcare professionals prescribing fluoroquinolone antibiotics (ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, ofloxacin) are reminded to be alert to the risk of 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.
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; and treatment with other first-line antibiotics has failed.
After conducting a further review, the MHRA sought the advice of the Commission on Human Medicines (CHM) on the success of existing 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 United Kingdom, 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 United Kingdom, 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. The MHRA also continues 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. The MHRA will communicate in due course any additional regulatory actions in the United Kingdom as a result of this review.
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 United Kingdom, 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.
- 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.
- Do not prescribe ciprofloxacin or levofloxacin for uncomplicated cystitis unless other antibiotics that are commonly recommended are considered inappropriate.
- 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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/fluoroquinolone-antibiotics-reminder-of-the-risk-of-disabling-and-potentially-long-lasting-or-irreversible-side-effects
In Hong Kong, there are registered pharmaceutical products containing systemic fluoroquinolones for use in human, including ciprofloxacin (51 products), levofloxacin (46 products), moxifloxacin (6 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 levofloxacin (13 cases; of which 3 cases were related to tendinitis and/or neuropathy) and ofloxacin (4 cases; all cases were related to suicide/suicide attempt). The DH has received adverse drug reaction related to ciprofloxacin (one case) and moxifloxacin (one case), but these cases were not related to the disabling side effects mentioned in the above MHRA’s announcement. 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 13 May 2023. Letters to inform local healthcare professionals were issued by the DH 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/Thursday, Aug 31, 2023
Issued at HKT 16:00
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