Literature analysis on serious adverse events related to dabigatran etexilate
10.3760/cma.j.cn114015-20210304-00264
- VernacularTitle:达比加群酯相关严重不良事件文献病例分析
- Author:
Qian DING
1
;
Qingxia ZHANG
;
Suying YAN
Author Information
1. 首都医科大学宣武医院药学部/国家老年疾病临床医学研究中心，北京 100053
- Publication Type:Journal Article
- Keywords:
Dabigatran;
Anticoagulants;
Medication errors;
Adverse events
- From:
Adverse Drug Reactions Journal
2021;23(12):633-638
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the clinical characteristics of dabigatran etexilate-related serious adverse events(AE).Methods:Databases of CNKI, WanFang, PubMed, and Embase were searched as of October 31, 2020 and case reports on serious AE related to dabigatran etexilate were collected. Relevant information in patients (nationality, gender, age, weight, application of dabigatran etexilate, co-existing diseases and combined drugs, the occurrence, treatment and outcome of AE, etc.) was extracted and analyzed descriptively.Results:A total of 77 literature were included, involving 101 patients from 20 countries. There were 64 males (63.4%) and 37 females (36.6%), aged 56-94 years with the body weight of 38-193 kg. In terms of the reasons for medication, 87 were for prevention of stroke caused by atrial fibrillation, 12 were for the treatment of venous thromboembolism or for prevention of the possible venous thromboembolism, and the other 2 were not described. Co-existing diseases or past medical history were described in 88 patients, including hypertension, renal insufficiency, and type 2 diabetes mellitus, etc. Combined medication was described in 67 patients, of which drugs that might increase the risk of bleeding (non-steroidal anti-inflammatory drugs, clopidogrel, P-glycoprotein inhibitors, etc.) were used in 35 patients. Other combined drugs were antihypertensive drugs and hypoglycemic drugs, etc. Serious AE occurred from 2 minutes to 5 years after medication and 33 cases occurred within 1 month after the start of medication. Serious AE associated with dabigatran etexilate were bleeding in 81 patients (including gastrointestinal bleeding, intracerebral hemorrhage, coagulation disorder, etc.), kidney injury/renal failure in 8 patients, esophageal ulcer in 4 patients, liver injury in 2 patients, and thrombocytopenia, leukocyte fragmentation vasculitis, and severe cough with dyspnea in 1 patient respectively. The main measure taken after AE occurence was drug withdrawal. Those who were not improved after drug withdrawal were given symptomatic treatment, and hemodialysis were performed on those who fail to respond to the treatment. A total of 29 patients died and all of them had bleeding events. Among the 101 patients, 43 had medication errors, of which 33 had overdose, 6 had contraindications, and 4 had wrong administration methods.Conclusions:Serious AE related to dabigatran etexilate manifest mostly as bleeding in clinic and can occur from 2 minutes to 5 years after medication, which can lead to death in severe cases. Medication error is one of the important causes of serious AE related to dabigatran etexilate, so the label should be strictly followed when prescribing the drug and medi-cation guidance should be given to patients.
