MHRA Warnings

In January 2024 the Medicines and Healthcare Regulatory Agency (MHRA) imposed further restrictions on fluoroquinolones following reviews of potentially disabling and long lasting or irreversible adverse effects, sometimes affecting multiple body systems and senses.

Fluoroquinolones available in NHS Lothian (NHSL) are:

• ciprofloxacin 
• ofloxacin
• levofloxacin
• moxifloxacin

In NHSL these antibiotics are WATCH antibiotics and prescribing is restricted.

Advice for prescribers

 The new MHRA update directs that fluoroquinolones should be prescribed only:

1. when other commonly recommended antibiotics are inappropriate
2. recommended in approved guidelines
3. or on advice of an infection specialist

Prescribers should take account of all cautions, contraindications, and interactions, as well as the patient’s medical history and reports of previous adverse drug reactions.

Cautions for prescribing fluoroquinolones:

• Patients who are older than 60 years, have renal impairment, or have had solid-organ transplantation, and those being treated with a corticosteroid are at higher risk of tendon damage.
• Concomitant treatment with a fluoroquinolone and a corticosteroid should be avoided as the risk of fluoroquinolone-induced tendinitis and tendon rupture may be exacerbated.

Advice for prescribers to provide to patients.

Patients should be given advice about potential serious adverse drug reactions, and to stop treatment and seek advice at the first sign of any side effects involving:

• Tendon pain or swelling- if this happens, rest the painful area until you can see your doctor.
• Pain or swelling joints such as in shoulders, arms, or difficult walking. Muscle pain and weakness.
• Severe tiredness, depressed mood, anxiety, suicidal thoughts and behaviour, problems with memory or severe problems sleeping.
• Changes in vision, taste, smell, or hearing.
• Patients at risk of aortic aneurysm should be advice to seek medical attention if sudden-onset severe abdominal, chest or back pain develops.

These side-effects can affect patients irrespective of their age and risk factors, they can occur within 48 hours of commencing treatment or can be delayed for several months, or even occur after stopping treatment.

The fluoroquinolones safety data has more specific information on what prescribers should cover with patients.

The MHRA states this Patient Information Leaflet should be given to patients.

Report any suspected adverse drug reactions via the Yellow Card Website or the app.

The Medicines and Healthcare Regulatory Agency (MHRA) issued awareness of lung and hepatic side effects in all contexts -though most likely to be an issue with longer use.

Healthcare professionals prescribing nitrofurantoin should be alert to the risks of pulmonary and hepatic adverse drug reactions and advise patients to be vigilant for the signs and symptoms in need of further investigation.