tedizolid and Chemical-and-Drug-Induced-Liver-Injury

BackgroundTo investigate the adverse event (AE) profile of tedizolid and linezolid in post-marketing surveillance.Research design and methodsWe queried the worldwide FDA Adverse Event Reporting System and selected all records where tedizolid and linezolid were reported as suspect by removing potential duplicates. Disproportionality analysis was performed investigating designated medical events (DMEs) and specific AEs of clinical interest reported with tedizolid. The reporting odds ratios (RORs) were calculated, deemed significant by a lower limit of the 95% confidence interval (LL95%CI)>1, using linezolid as comparator. Case-by-case assessment of AEs reported in at least three cases with tedizolid was performed.ResultsOverall, 271 and 11,259 reports mentioning respectively tedizolid and linezolid were recorded, of which respectively 59 and 4,473 patients with DMEs or selected AEs were found. No difference emerged for the selected AEs except for increased reporting of

Topics: Adverse Drug Reaction Reporting Systems; Anti-Bacterial Agents; Chemical and Drug Induced Liver Injury; Databases, Factual; Female; Humans; Linezolid; Male; Middle Aged; Oxazolidinones; Pharmacovigilance; Product Surveillance, Postmarketing; Tetrazoles; United States; United States Food and Drug Administration