Impact Of Regulatory Actions Research Articles

Systematic review on the safety of the use of quinolones in the pediatric population

Background: The safety of fluoroquinolones in the pediatric population has been a matter of concern due to the potential for adverse effects such as growth cartilage toxicity. Despite their broad antimicrobial spectrum and efficacy, the prescription of fluoroquinolones in children and adolescents is limited by the risk of arthralgias and other side effects. This study aims to evaluate the safety of fluoroquinolones in pediatric patients and the impact of regulatory actions on their prescription. Material and methods: A systematic review of studies investigating the safety of fluoroquinolones in the pediatric population was conducted. Studies that met specific inclusion criteria were selected, and relevant information on the decrease in fluoroquinolone prescriptions and their adverse effects was extracted. Results: In the study on the safety and tolerability of quinolones in the pediatric population, 22% (199/904) of patients experienced adverse events following treatment with quinolones. Gastrointestinal disorders, such as nausea and diarrhea, were the most frequent, affecting 12% (108/904) of patients. This was followed by skin rashes and effects on the central nervous system, at 5% (45/904) and 3% (27/904) respectively. Moxifloxacin demonstrated good tolerability across all age cohorts, without significant joint or neuropathic adverse findings. Specific safety studies of moxifloxacin confirmed its safety, showing no significant differences in safety variables compared to other antibiotics. Conclusion: It is crucial to continue monitoring the safety of fluoroquinolones in the pediatric population to ensure an adequate balance between the benefits and risks of their use.

Critically reviewing impact of regulatory actions, not just FDA's

Theirmessagethatrigorousevaluation of impact of FDA regulatory actions has beenlimited and that ‘new’ study designs are available andmay be used in future evaluations is fully supported.However, what comes as a bit of a surprise is the lackof attention that is paid to the rest of the world efforts tostudy impact of regulatory actions. In the Europeancontext, with the new pharmacovigilance legislation thatcame into effect last year, evaluation of the impact ofregulatory actions has become mandatory.