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Pharmacotherapy Management for COVID-19 and Cardiac Safety: A Data Mining Approach for Pharmacovigilance Evidence from the FDA Adverse Event Reporting System (FAERS).
Yuan, Jing; Li, Minghui; Yu, Yiqun; Lee, Tai-Ying; Lv, Gang; Han, Bing; Xiang, Xiaoqiang; Lu, Z Kevin.
  • Yuan J; Department of Clinical Pharmacy, School of Pharmacy, Fudan University, 826 Zhangheng Road, Pudong, Shanghai, 201203, People's Republic of China.
  • Li M; University of Tennessee Health Science Center, Memphis, TN, USA.
  • Yu Y; Department of Pharmacy, Minhang Hospital, Fudan University, Shanghai, People's Republic of China.
  • Lee TY; University of South Carolina, 715 Sumter Street, CLS Building 311, Columbia, SC, 29208, USA.
  • Lv G; General Surgery Department, 1st Medical Center of PLA General Hospital, Beijing, China.
  • Han B; Department of Pharmacy, Minhang Hospital, Fudan University, Shanghai, People's Republic of China.
  • Xiang X; Department of Clinical Pharmacy, School of Pharmacy, Fudan University, 826 Zhangheng Road, Pudong, Shanghai, 201203, People's Republic of China. xiangxq@fudan.edu.cn.
  • Lu ZK; University of South Carolina, 715 Sumter Street, CLS Building 311, Columbia, SC, 29208, USA. lu32@email.sc.edu.
Drugs Real World Outcomes ; 8(2): 131-140, 2021 Jun.
Article in English | MEDLINE | ID: covidwho-1077714
Semantic information from SemMedBD (by NLM)
1. Chemotherapy care TREATS COVID-19
Subject
Chemotherapy care
Predicate
TREATS
Object
COVID-19
2. Pharmacotherapy AFFECTS cardiac event
Subject
Pharmacotherapy
Predicate
AFFECTS
Object
cardiac event
3. Pharmacotherapy TREATS COVID-19
Subject
Pharmacotherapy
Predicate
TREATS
Object
COVID-19
4. Antimalarials PREDISPOSES cardiac event
Subject
Antimalarials
Predicate
PREDISPOSES
Object
cardiac event
5. Heart LOCATION_OF Serious Adverse Event
Subject
Heart
Predicate
LOCATION_OF
Object
Serious Adverse Event
6. hydroxychloroquine ADMINISTERED_TO Persons
Subject
hydroxychloroquine
Predicate
ADMINISTERED_TO
Object
Persons
7. Coronavirus Infections PROCESS_OF Persons
Subject
Coronavirus Infections
Predicate
PROCESS_OF
Object
Persons
8. Increased risk COEXISTS_WITH COVID-19
Subject
Increased risk
Predicate
COEXISTS_WITH
Object
COVID-19
9. hydroxychloroquine ADMINISTERED_TO Patients
Subject
hydroxychloroquine
Predicate
ADMINISTERED_TO
Object
Patients
10. azithromycin ADMINISTERED_TO Patients
Subject
azithromycin
Predicate
ADMINISTERED_TO
Object
Patients
11. COVID-19 PROCESS_OF Patients
Subject
COVID-19
Predicate
PROCESS_OF
Object
Patients
12. Chemotherapy care TREATS COVID-19
Subject
Chemotherapy care
Predicate
TREATS
Object
COVID-19
13. Pharmacotherapy AFFECTS cardiac event
Subject
Pharmacotherapy
Predicate
AFFECTS
Object
cardiac event
14. Pharmacotherapy TREATS COVID-19
Subject
Pharmacotherapy
Predicate
TREATS
Object
COVID-19
15. Antimalarials PREDISPOSES cardiac event
Subject
Antimalarials
Predicate
PREDISPOSES
Object
cardiac event
16. Heart LOCATION_OF Serious Adverse Event
Subject
Heart
Predicate
LOCATION_OF
Object
Serious Adverse Event
17. hydroxychloroquine ADMINISTERED_TO Persons
Subject
hydroxychloroquine
Predicate
ADMINISTERED_TO
Object
Persons
18. Coronavirus Infections PROCESS_OF Persons
Subject
Coronavirus Infections
Predicate
PROCESS_OF
Object
Persons
19. Increased risk COEXISTS_WITH COVID-19
Subject
Increased risk
Predicate
COEXISTS_WITH
Object
COVID-19
20. hydroxychloroquine ADMINISTERED_TO Patients
Subject
hydroxychloroquine
Predicate
ADMINISTERED_TO
Object
Patients
21. azithromycin ADMINISTERED_TO Patients
Subject
azithromycin
Predicate
ADMINISTERED_TO
Object
Patients
22. COVID-19 PROCESS_OF Patients
Subject
COVID-19
Predicate
PROCESS_OF
Object
Patients
ABSTRACT

BACKGROUND:

Several pharmacological agents, such as chloroquine/hydroxychloroquine, have been promoted for COVID-19 treatment or pre-exposure prophylaxis. However, no comprehensive evaluation of the safety of these possible agents is available, and is urgently needed.

OBJECTIVE:

The purpose of this study was to investigate the risks of cardiac adverse events associated with the possible pharmacotherapies for COVID-19, including certain antimalarial, antiviral, and antibiotic drugs. PATIENTS AND

METHODS:

We conduced retrospective pharmacovigilance analyses of the US Food and Drug Administration Adverse Event Reporting System database. The reporting odds ratio (ROR), a data mining algorithm commonly used in pharmacovigilance assessment, was generated to quantify the detection signal of adverse events.

RESULTS:

Among individuals without coronavirus infection from 2015 Q1 to 2020 Q1, increased risks for cardiac disorders were found for antiviral agents such as chloroquine/hydroxychloroquine (ROR 1.68; 95% confidence interval [CI] 1.66-1.70), lopinavir/ritonavir (ROR 1.52; 95% CI 1.39-1.66), and antibiotics such as azithromycin (ROR 1.37; 95% CI 1.30-1.44) and ceftriaxone (ROR 1.92; 95% CI 1.80-2.05). Increased serious cardiac adverse events, including myocardial infarction, arrhythmia, and cardiac arrest, were also reported for these drugs. Further analyses of individuals with coronavirus infections revealed that 40% of individuals receiving chloroquine/hydroxychloroquine reported serious cardiac adverse events. Two cases resulted in QT prolongations and one case resulted in cardiac arrest. Chloroquine/hydroxychloroquine and azithromycin contributed to all the QT prolongation and cardiac arrest cases.

CONCLUSIONS:

The current pharmacotherapies for COVID-19 are associated with increased risks of cardiac adverse events. Variations in the cardiac safety profiles of these pharmacotherapies were also observed. Clinicians should closely monitor patients with COVID-19, especially those at high risk, using chloroquine/hydroxychloroquine and azithromycin.

Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Type of study: Evidence synthesis Language: English Journal: Drugs Real World Outcomes Clinical aspect: Etiology Year: 2021

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Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Type of study: Evidence synthesis Language: English Journal: Drugs Real World Outcomes Clinical aspect: Etiology Year: 2021
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