UK MHRA strengthens regulations on fluoroquinolone antibiotics
23 Jan 2024
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Source: Pharmaceutical Technology
The MHRA’s new restrictions on fluoroquinolone antibiotics limit their use to ensure patient safety. Credit: fizkes / Shutterstock.com.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has introduced further restrictions on the usage of fluoroquinolone antibiotics, strengthening the previous regulations.
These antibiotics, administered systemically by injection, mouth or inhalation, are now reserved for situations where no other appropriate antibiotics are available.
The decision comes after a comprehensive review of the long-term side effects associated with these drugs and aims to enhance patient safety. The agency also sought advice from the Commission on Human Medicines.
The MHRA’s review included an assessment of Yellow Card reports from patients and healthcare specialists, as well as the experiences of individuals affected by adverse reactions.
The new guidelines are a response to reports of lasting or disabling side effects, some of which occurred when fluoroquinolones were prescribed for less severe infections or non-bacterial conditions.
Healthcare specialists are advised to prescribe fluoroquinolone only when other commonly recommended antibiotics are unsuitable.
This could be due to antibiotic resistance, contraindications, side effects from other antibiotics or the failure of other treatments.
The MHRA emphasises the importance of being vigilant about the risk of suicidal thoughts and behaviours associated with fluoroquinolone use.
Serious adverse reactions include tendon rupture or tendinitis, pain and weaknessweaknessweaknessweaknessweaknessweaknessweakness in muscles, joint pain and swelling, peripheral neuropathy and central nervous system effects.
MHRA chief safety officer Dr Alison Cave stated: “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.
“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.”
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