LONDON, England – Following a review of the effectiveness of current measures to reduce the risk of potentially long-term or irreversible side effects associated with fluoroquinolone antibiotics, the MHRA has introduced further restrictions to limit their use.
From today, fluoroquinolone antibiotics given systemically (by mouth, injection, or inhalation) must only be administered when no other antibiotics are appropriate for use, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced. This means that fluoroquinolones should only be prescribed when other recommended antibiotics have failed, will not work due to resistance, or are unsafe to use in an individual patient.
This is a strengthening of the previous regulations which stated that fluoroquinolones should not be prescribed for mild to moderate or self-limiting infections, or non-bacterial conditions.
The MHRA conducted a thorough review into the effectiveness of current measures to reduce the risk of potentially long-term adverse reactions to fluoroquinolone antibiotics and sought advice from the Commission on Human Medicines (CHM). The review process considered available evidence, including Yellow Card reports submitted by patients and healthcare professionals, and the experiences of people affected by these side effects.
The restrictions have been introduced following Yellow Card reports from patients who have experienced long-lasting or disabling reactions following use of fluoroquinolones, in some cases prescribed for mild to moderate or self-limiting infections, or non-bacterial conditions.
The MHRA is committed to listening to patient voices and continuously reviews data to improve patient safety.
Dr Alison Cave, MHRA chief safety officer, said:
“Patient safety is our top priority. We have listened to the experience of patients regarding long-lasting and potentially irreversible adverse reactions following use of fluoroquinolone antibiotics, in some cases prescribed for mild-to-moderate infections. We recognise fully the importance of limiting the use of these medicines.
“That’s why, from today, fluoroquinolones should only be prescribed when usage of other antibiotics is inappropriate. Fluoroquinolones use should be discontinued at the first signs of a serious adverse reaction.
“Patients using fluoroquinolone antibiotics should carefully read the advice in the patient information leaflet about possible adverse reactions and seek immediate medical advice if they experience any side effects involving symptoms relating to tendons, muscles, joints, nerves or mental health at any point during treatment. Please continue to report any suspected adverse reactions to fluoroquinolones via the Yellow Card scheme.”
