Updated MHRA fluoroquinolone advice

Background
MHRA (Medicines and Healthcare products Regulatory Agency) have issued updated advice recommending further restrictions on the use of systemic fluoroquinolones. Due to concerns regarding potential disabling and long-lasting or irreversible side effects they are now restricted to the following individual patient scenarios:

  • 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 in the patient requiring treatment to be stopped
  • treatment with other first-line antibiotics has failed

Discussion
SAPG supports the restrictive use of fluoroquinolones in NHS Scotland and recommends that Antimicrobial Management Team (AMTs) within health boards review local guidance in view of the MHRA advice.

Since fluoroquinolones are frequently used as alternatives to penicillin in suspected allergy, SAPG emphasises the importance of careful assessment of penicillin allergy and encourages de-labelling where appropriate and where facilities and governance processes have been agreed (see Penicillin Allergy De-labelling (sapg.scot)).

SAPG also recognises the potential for unintended consequences that may arise because of the MHRA advice. Fluoroquinolones have an important position in many infection management guidelines in Scottish health boards as alternatives to beta lactams in true penicillin allergy. Fluoroquinolones are also frequently the only available oral agent for some resistant Gram-negative infections. The MHRA advice may inadvertently promote the selection of broader spectrum and intravenous (IV) alternatives to fluoroquinolones, or delay or prevent IV to oral switch. This may lead to prolonged hospital stay, increased use of IV devices and the use of broader spectrum agents with associated risks including vascular device related infections, antimicrobial resistance and increased treatment costs.

SAPG supports AMTs in the use of fluoroquinolones as part of the broader local antimicrobial stewardship (AMS) programme which includes timely IV to oral switch. It is reasonable for AMTs to consider fluoroquinolones in patients where the only alternative antibiotic therapy would be a broader spectrum alternative, or one delivered by the IV route. Risks and benefits of fluoroquinolones should be carefully considered and discussed in individual patients and balanced against the risks and benefits of alternative therapies.

Members are asked to:
Review local guidance and practice in view of this latest MHRA fluoroquinolones guidance (as per usual local medicine governance processes) but also consider the wider implications of restrictions on the promotion of intravenous and broader spectrum antibiotic therapy.



  Scottish Antimicrobial Prescribing Group (SAPG) | March 2024

Content updated March 2024