Rhabdomyolysis Associations with Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System (FAERS).

Introduction: Daptomycin, macrolides, trimethoprim-sulfamethoxazole, linezolid, fluoroquinolones, and cefdinir are known to be associated with rhabdomyolysis. Other antibiotics may also lead to rhabdomyolysis, but no study has systemically compared rhabdomyolysis associations for many available antibiotics. Objectives: The objective of this study was to evaluate the association between rhabdomyolysis and many available antibiotics using the FDA Adverse Event Report System (FAERS). Methods: FAERS reports from January 1, 2004 to December 31, 2017 were included in the study. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify rhabdomyolysis cases. Reporting Odds Ratios (RORs) and corresponding 95% confidence intervals (95%CI) for the association between antibiotics and rhabdomyolysis were calculated. An association was considered statistically significant when the lower limit of the 95%CI was greater than 1.0. Results: A total of 2,334,959 reports (including 7,685 rhabdomyolysis reports) were considered, after inclusion criteria were applied. Daptomycin had the greatest proportion of rhabdomyolysis reports, representing 5.5% of all daptomycin reports. Statistically significant rhabdomyolysis RORs (95% CI) for antibiotics were (in descending order): daptomycin 17.94 (14.08-22.85), cefditoren 8.61 (3.54-20.94), cefaclor 7.16 (2.28-22.49), erythromycin 5.93 (3.17-11.10), norfloxacin 4.50 (1.44-14.07), clarithromycin 3.95 (2.77-5.64), meropenem 3.19 (1.51-6.72), azithromycin 2.94 (1.96-4.39), cefdinir 2.84 (1.06-7.62), piperacillin-tazobactam 2.61 (1.48-4.61), trimethoprim-sulfamethoxazole 2.53 (1.52-4.21), linezolid 2.49 (1.47-4.21), ciprofloxacin 2.10 (1.51-2.92). Conclusions: This study confirms prior evidence for rhabdomyolysis associations with daptomycin, macrolides, trimethoprim-sulfamethoxazole, linezolid, fluoroquinolones, and cefdinir. This study also identifies previously unknown rhabdomyolysis associations with meropenem, cefditoren, cefaclor, and piperacillin-tazobactam.

Teng C ，Baus C ，Wilson JP ，Frei CR ... -  《International Journal of Medical Sciences》

Comparing Acute Kidney Injury Reports Among Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System (FAERS).

Patek TM ，Teng C ，Kennedy KE ，Alvarez CA ，Frei CR ... -  《-》

Torsades de pointes and QT prolongation Associations with Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System.

Teng C ，Walter EA ，Gaspar DKS ，Obodozie-Ofoegbu OO ，Frei CR ... -  《International Journal of Medical Sciences》

Delirium Associations with Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System (FAERS).

Ertapenem, cefepime, imipenem, ofloxacin, ceftazidime, clarithromycin, cefaclor, levofloxacin, linezolid, moxifloxacin, azithromycin, piperacillin-tazobactam, trimethoprim-sulfamethoxazole, metronidazole, ciprofloxacin, and cefuroxime are known to be associated with delirium. Other antibiotics may also lead to delirium, but no study has systemically compared delirium associations for many available antibiotics. The objective of this study was to evaluate the association between delirium and antibiotics using the FDA Adverse Event Reporting System (FAERS). FAERS reports from January 1, 2004 to December 31, 2018 were included in the study. Reporting odds ratios (RORs) and corresponding 95% confidence intervals (95% CI) for the association between antibiotics and delirium were calculated. An association was considered to be statistically significant when the lower limit of the 95% CI was greater than 1.0. A total of 10,015,622 reports (including 16,982 delirium reports) were considered, after inclusion criteria were applied. Statistically significant delirium RORs (95% CI) for antibiotics were: ertapenem 21.07 (16.38-27.10), cefepime 9.8 (6.37-15.09), imipenem 9.68 (6.75-13.89), ofloxacin 7.73 (4.00-14.92), ceftazidime 6.09 (2.73-13.62), clarithromycin 5.34 (4.37-6.53), cefaclor 5.32 (1.71-16.58), ampicillin-sulbactam 4.49 (2.13-9.45), levofloxacin 4.47 (3.88-5.16), linezolid 4.33 (3.28-5.72), moxifloxacin 3.51 (2.81-4.38), azithromycin 2.76 (2.09-3.64), piperacillin-tazobactam 2.41 (1.47-3.93), trimethoprim-sulfamethoxazole 2.36 (1.61-3.47), metronidazole 1.85 (1.31-2.60), ciprofloxacin 1.83 (1.44-2.33), and cefuroxime 1.81 (1.03-3.20). This study found statistically significant increased risk of reporting delirium with ertapenem, cefepime, imipenem, ofloxacin, ceftazidime, clarithromycin, cefaclor, ampicillin-sulbactam, levofloxacin, linezolid, moxifloxacin, azithromycin, piperacillin-tazobactam, trimethoprim-sulfamethoxazole, metronidazole, ciprofloxacin, and cefuroxime.

Teng C ，Frei CR 《-》

Hypoglycemia Associated with Antibiotics Alone and in Combination with Sulfonylureas and Meglitinides: An Epidemiologic Surveillance Study of the FDA Adverse Event Reporting System (FAERS).

Kennedy KE ，Teng C ，Patek TM ，Frei CR ... -  《-》