Korean J Clin Pharm.  2017 Sep;27(3):143-149. 10.24304/kjcp.2017.27.3.143.

Analysis of L-asparaginase Related Adverse Reaction

• Ko KM
• La HO

• KMID: 2405668
• DOI: http://doi.org/10.24304/kjcp.2017.27.3.143

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.

Keyword

Asparaginase; drug-related adverse reaction; adverse drug reaction reporting systems; drug toxicity

MeSH Terms

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
Asparaginase