Abstract
Cefaclor, a second-generation oral cephalosporin, is the most frequently prescribed cephalosporin in Korea. Studies, however, have yet to analyze the incidence of cefaclor-associated adverse drug reactions (ADRs), including hypersensitivity (HS), according to total national usage rates. This study aimed to investigate the incidence rates and clinical features of cefaclor ADRs reported to the Korean Adverse Event Reporting System (KAERS) and Health Insurance Review and Assessment Service (HIRA) database for the most recent 5 years. Reviewing the HIRA database, which contains information on all insurance claims, including prescribed medications and patient demographics, we identified the total number of individuals who had been prescribed cefaclor and other cephalosporins including 2nd generation without cefaclor and 3rd generation antibiotics from January 2014 to December 2018. Additionally, we retrospectively analyzed all ADRs reported to the KAERS for these drugs over the same study period. Incidence rates for ADRs, HS, and anaphylaxis to cefaclor were 1.92/10,000 persons, 1.17/10,000 persons, and 0.38/10,000 persons, respectively, lower than those to other 2nd and 3rd cephalosporins. Among all ADRs, HS (60.9% vs. 43.6% vs. 44.8%, P <0.001) and anaphylaxis (19.8% vs. 4.6% vs. 4.7%, P <0.001) were more common for cefaclor than for other 2nd and 3rd cephalosporins. Females, individuals under 65 years of age, concomitant use of drugs, and serious ADRs were more strongly associated with HS to cefaclor than with HS to other 2nd and 3rd cephalosporins. In a nationwide database for the Korean population, the incidence of cefaclor-induced ADRs, particularly HS and anaphylaxis, was high. Female sex, age younger than 65 years, and concomitant use of drugs may be associated with HS to cefaclor.
Highlights
Adverse drug reactions (ADRs) are common and responsible for significant morbidity and mortality
ADRs were subdivided into type A and type B reactions as previously described, and type B reactions mainly included hypersensitivity reactions that were subdivided into immediate and delayed HS
Culprit drugs are coded according to the Anatomical Therapeutic Chemical (ATC) classification system, and adverse events are coded according to World Health Organization Adverse Reaction Terminology (WHO-ART) which has been used in Korea since 2006
Summary
Adverse drug reactions (ADRs) are common and responsible for significant morbidity and mortality. ADRs were subdivided into type A and type B reactions as previously described, and type B reactions mainly included hypersensitivity reactions that were subdivided into immediate and delayed HS. Drug hypersensitivity (HS) is unpredictable, dose independent after the dose exceeding the threshold, and potentially life-threatening [4,5]. Several studies on the incidence of HS and/ or anaphylaxis to cephalosporins have been conducted on large subjects [7,8], and past history of HS to penicillin or cephalosporin is the most important risk factor for reacting to cephalosporins [9]. Data on the incidence thereof and results on risk factors for drug HS are unclear, because its diagnosis depends on a patient’s history and clinical manifestation. Studies have shown that the incidence of drug HS can be affected by various factors, such as study population, definition, and methods of data analysis [3,10]
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