Systemic quinolones and risk of retinal detachment I: analysis of data from the US FDA adverse event reporting system
| العنوان: | Systemic quinolones and risk of retinal detachment I: analysis of data from the US FDA adverse event reporting system |
|---|---|
| المؤلفون: | Lise M. Bjerre, Daniel Krewski, Derek Tsui, Donald R. Mattison, Abdallah Alami, Franco Momoli, Mohamed Kadry Taher, Christopher A. Gravel |
| المصدر: | Expert Opinion on Drug Safety. 21:269-276 |
| بيانات النشر: | Informa UK Limited, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Adult, Male, Risk, Drug, medicine.medical_specialty, Adolescent, medicine.drug_class, media_common.quotation_subject, Moxifloxacin, Antibiotics, Quinolones, Sensitivity and Specificity, Pharmacovigilance, Young Adult, Adverse Event Reporting System, Internal medicine, Adverse Drug Reaction Reporting Systems, Humans, Medicine, Potency, Pharmacology (medical), Child, Aged, media_common, Aged, 80 and over, United States Food and Drug Administration, business.industry, Pharmacoepidemiology, Retinal Detachment, Infant, Retinal detachment, General Medicine, Middle Aged, Quinolone, medicine.disease, United States, Anti-Bacterial Agents, Child, Preschool, Female, business, medicine.drug |
| الوصف: | Background Quinolones comprise a class of antibiotics that are globally preferred for treating a wide range of bacterial infections due to their potency, broad coverage, favorable pharmacologic profile, and mostly mild to moderate adverse reactions. Spontaneous reports on adverse drug events (ADE) and data from some pharmacoepidemiologic studies have raised concerns regarding quinolones and risk of retinal detachment (RD). This study examined ADE reports submitted to FDA adverse event reporting system (FAERS) for evidence on quinolone-associated RD risk. Research design and methods We identified all reports of RD in FAERS between 2010-2019. We compared ADE signals between quinolones and selected medications that were previously associated with RD, and with reference drugs not known to cause RD. For signal detection, we used two disproportionality techniques: the proportional reporting ratio (PRR) and multi-item gamma Poisson shrinker (MGPS), which are known for their higher sensitivity and specificity for ADE signal detection, respectively. Results Moxifloxacin showed a positive and significant PRR signal for RD [PRR: 2.54 (1.60, 4.04)], and a marginally significant EBGM signal [EBGM: 2.21 (1.41, 3.02)]. Conclusion Moxifloxacin is the only quinolone showing a positive disproportionality signal for RD. Further epidemiologic research is needed to clarify the association between moxifloxacin and the risk of RD. |
| تدمد: | 1744-764X 1474-0338 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::293808d584b0ab76984e377f139150d2 https://doi.org/10.1080/14740338.2022.1993187 |
| رقم الأكسشن: | edsair.doi.dedup.....293808d584b0ab76984e377f139150d2 |
| قاعدة البيانات: | OpenAIRE |
PDF full text from Publisher | تدمد: | 1744764X 14740338 |
|---|