Citation

Barbosa LHLA, Silva ARO, Carvalho-Assef APD, Lima EC, da Silva FAB. Front. Pharmacol. 2022; 13.

Copyright

(Copyright © 2022, Frontiers Media)

DOI

10.3389/fphar.2022.948339

PMID

unavailable

Abstract

Antibacterial drugs are a widely used drug class due to the frequency of infectious diseases globally. Risks knowledge should ground these medicines' selection. Data mining in large databases is essential to identify early safety signals and to support pharmacovigilance systems. We conducted a cross-sectional study to assess adverse drug events related to antibiotics reporting between December 2018 and December 2021 in the Brazilian database (Vigimed/VigiFlow). We used the Reporting Odds Ratio (ROR) disproportionality analysis method to identify disproportionate reporting signals (SDR), referring to statistical combinations between drugs and adverse events. Vancomycin was the most reported antibiotic (n = 1,733), followed by ceftriaxone (n = 1,277) and piperacillin and tazobactam (n = 1,024). We detected 294 safety signals related to antibacterials. We identified azithromycin leading in the number of safety signals (n = 49), followed by polymyxin B (n = 25). Of these, 95 were not provided for in the drug label and had little or no reports in the medical literature. Three serious events are associated with ceftazidime and avibactam, a new drug in the Brazilian market. We also found suicide attempts as a sign associated with amoxicillin/clavulanate. Gait disturbance, a worrying event, especially in the elderly, was associated with azithromycin. Our findings may help guide further pharmacoepidemiologic studies and monitoring safety signals in pharmacovigilance. Copyright © 2022 Barbosa, Silva, Carvalho-Assef, Lima and da Silva.

Language: en

Keywords

human; Brazil; depression; anxiety; suicide attempt; pharmacoepidemiology; major clinical study; vomiting; controlled study; tachycardia; influenza; edema; drug safety; medical literature; sepsis; drug fatality; cross-sectional study; risk benefit analysis; tremor; asthma; fever; eosinophilia; drug marketing; lymphocytopenia; hypertension; side effect; asthenia; pharyngitis; pruritus; antibiotic agent; postmarketing surveillance; amoxicillin; cotrimoxazole; drug monitoring; dyspnea; coughing; dermatitis; paresthesia; thorax pain; amoxicillin plus clavulanic acid; angioneurotic edema; larynx edema; dyspepsia; bronchospasm; pneumonia; factual database; gentamicin; flushing; rhinitis; drug labeling; unspecified side effect; ciprofloxacin; urinary tract infection; dysesthesia; clindamycin; papule; Article; amikacin; ceftazidime; hyperthermia; consciousness disorder; clarithromycin; ceftriaxone; immune deficiency; phlebitis; skin disease; colitis; hypesthesia; hyperhidrosis; gait disorder; petechia; sinusitis; peripheral edema; azithromycin; acute respiratory failure; dysphonia; decreased appetite; osteoarthritis; skin defect; psoriatic arthritis; cardiopulmonary insufficiency; aztreonam; cefuroxime; oxacillin; throat irritation; rhinorrhea; vancomycin; cefalotin; levofloxacin; piperacillin plus tazobactam; moxifloxacin; eyelid edema; throat disease; swelling; tobramycin; papular urticaria; sneezing; teicoplanin; cefazolin; lip swelling; oropharynx pain; body weight loss; coronavirus disease 2019; pharmacovigilance; adverse drug reaction reporting systems; anti-bacterial agents; avibactam; avibactam plus ceftazidime; ceftaroline fosamil; cornea edema; drug-related side effects and adverse reactions; miliaria; ocular hyperemia; pharmacovigilance database; polymyxin B; productive cough; safety signals; spontaneous reports