Abstract
Fluoroquinolones are a widely prescribed class of antibiotics for the treatment of bacterial infections. However, their use is associated with significant adverse effects, including tendinopathies, peripheral neuropathies, and phototoxic reactions. Despite these risks, off-label use persists, raising major public health and regulatory concerns. This study explores the historical development of fluoroquinolones, the nature and prevalence of their adverse effects, and the regulatory responses. The analysis identifies the challenges posed by off-label prescribing and emphasises the need for more rigorous oversight at the European Union level. Key proposed measures include reinforcing pharmacovigilance frameworks, developing a centralised database for evidence-based off-label uses, and implementing mechanisms to restrict inappropriate prescriptions. These regulatory initiatives aim to reduce the risks associated with off-label use while balancing the autonomy of clinical practice. Strengthening these measures would address the gaps in current national approaches and enhance patient safety across Member States.