Analysis of L-asparaginase Related Adverse Reaction
10.24304/kjcp.2017.27.3.143
- Author:
Kyung Mi KO
1
;
Hyen O LA
Author Information
1. Department of basic/clinical pharmacology, The Catholic University, Seoul 06591, Republic of Korea.
- Publication Type:Original Article
- Keywords:
Asparaginase;
drug-related adverse reaction;
adverse drug reaction reporting systems;
drug toxicity
- MeSH:
Adverse Drug Reaction Reporting Systems;
Asparaginase;
Drug-Related Side Effects and Adverse Reactions;
Hematology;
Hospitalization;
Humans;
Hypersensitivity;
Lymphoma;
Medical Records;
Pancreatitis;
Pharmacovigilance;
Precursor Cell Lymphoblastic Leukemia-Lymphoma;
Seoul;
Thrombosis
- From:Korean Journal of Clinical Pharmacy
2017;27(3):143-149
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
OBJECTIVE: L-asparaginase (L-ASP) is a critical agent for the treatment of acute lymphoblastic leukemia and lymphoma, which is associated with serious toxicities including hypersensitivity, pancreatitis and thrombosis. METHODS: To evaluate the toxicity of L-ASP in real clinical settings, we included the patients with L-ASP adverse drug reactions (ADRs) reported in a regional pharmacovigilance center of Seoul St. Mary's hospital from January 2014 to December 2015. RESULTS: A total of 83 cases of L-ASP related ADRs were reported in 54 patients. Of these 83 cases, 65 cases (78.3%, 65/83) were spontaneously reported and 18 cases (21.7%, 18/83) were detected by further medical records review. Of the patients with ADRs, pediatric patients accounted for 83.3% of the cases (45/54) and median age was 9 years. The most common clinical manifestations of ADRs were hematology manifestations (31.3%, 26/83), followed by hepatobiliary manifestations (18.1%, 15/ 83). Thirty-four serious ADRs were reported in 19 patients. The sserious ADR group showed significantly longer hospitalization and higher rate of discontinuation of L-ASP than the non-serious ADR group (p = 0.005, 0.03). The most common clinical manifestations of serious ADRs were hepatobiliary manifestations (41.2%, 14/34). In total, 8 cases (9.6%, 8/ 83) of unlabeled ADRs were identified. They were serious ADRs. CONCLUSION: We identified unlabeled serious ADRs of L-ASP. Also, correlations were observed between serious ADRs and length of hospitalization, discontinuation rate respectively. Further investigations and developed spontaneous ADR reporting systems are needed to evaluate these correlations.
