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Originator: MHRA Dear Doctor Letter

From: Dr June Raine, Director, Vigilance and Risk Management of Medicines

Issue date: 21-Mar-2019 14:30:47

This alert has been issued to:
  • MHRA (Medicines) Drug Alerts (Various Recipients)
  • NHS Regional Offices
  • NHS Foundation Trusts (England) - Medical Director
  • NHS Foundation Trusts (England) - Chief Executive
  • NHS Trusts (England) - Medical Director
  • Territorial CMOs in Northern Ireland, Scotland & Wales
  • Regional Directors of Public Health
  • CMO Urgent Messages - Recipients on Public Health Link
  • NHS Trusts (England) - Chief Executive

  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • Social Care Providers (registered with CAS)
  • Special Health Authorities
  • CMO Urgent Messages - Non-NHS Recipients on Public Health Link
  • MHRA (Medicines) Drug Alerts - Non-NHS Recipients
  • Consultants in Communicable Diseases
  • Director of Public Health

Action category: Action within 48 hours

Title: Fluoroquinolone antibiotics: new restrictions and precautions due to very rare reports of disabling and potentially long-lasting or irreversible side effects

Broadcast content:

See alert for new restrictions and precautions for fluoroquinolone antibiotics (ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin) following a review of disabling, long-lasting or potentially irreversible adverse reactions affecting musculoskeletal (including tendonitis and tendon rupture) and nervous systems with fluoroquinolone antibiotics.

The indications for fluoroquinolone antibiotics have been restricted and they should not be used in non-severe or self-limiting infections, non-bacterial conditions, or some mild to moderate infections.

Prescribers and dispensers of fluoroquinolones should advise patients to stop treatment at the first signs of a serious adverse reaction, such as tendinitis or tendon rupture, and to contact their doctor immediately for further advice.

Fluoroquinolones are widely used antibiotics and this advice is relevant to all stages of care including, general practice, pharmacy, dentistry, respiratory, ENT, urology, infectious diseases, gynaecology, intensive care, A&E, general surgery, dermatology, ophthalmology, neurology, orthopaedics, general medicine and microbiology.

Additional information: NHS England Regional Offices : please cascade to GP's and Community Pharmacies. Please include the following text in your covering email when sharing with GPs:

All GPs and healthcare professionals in GP surgeries should be aware of the new restrictions and precautions for fluoroquinolone antibiotics (ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin)

Alert reference: DDL_ Fluoroquinolone antibiotics

Cascade to:
  • #GP#
  • #HospitalPharmacy#

Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency