
UK health regulators have announced new restrictions on the use of fluoroquinolone antibiotics.
In a press release earlier this week, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) said that fluoroquinolone antibiotics given systematically must only be administered when no other appropriate antibiotics are available for use. That includes situations where other recommended antibiotics have failed, are ineffective because of resistance, or are unsafe to use in individual patients.
Concerns about fluoroquinolones have grown in recent years in the United Kingdom and other countries, including the United States, because of reports and subsequent data showing increased risk of serious adverse reactions, including tendonitis or tendon rupture, muscle pain and weakness, joint pain, peripheral neuropathy, and central nervous system effects. The US Food and Drug Administration has issued several black box warnings for fluoroquinolones in response to those risks.
Mental health concerns
Previous MHRA regulations stated that fluoroquinolones should not be used for mild to moderate or self-limiting infections, or for non-bacterial infections. The MHRA says the new regulations are in response to Yellow Card reports from patients who have experienced long-term adverse reactions to fluoroquinolones.
They also follow a September 2023 drug safety update from MHRA that warned clinicians prescribing fluoroquinolones to be alert to the risk of psychiatric reactions, including suicidal thoughts.
"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," MHRA Chief Safety Officer Allison Cave said. "We recognise fully the importance of limiting the use of these medicines."
Cave urged patients on fluoroquinolones to read the patient information leaflet and seek immediate medical advice if they experience side effects involving symptoms relating to tendons, joints, muscles, nerves, or mental health at any point during treatment.