Hyo-Ju Park1, Ju-Young Shin1, Mi-Hee Kim1, Byung-Joo Park2. 1. Korea Institute of Drug Safety and Risk Management, Seoul 110-750, South Korea. 2. Korea Institute of Drug Safety and Risk Management, Seoul 110-750, South Korea; Department of Preventive Medicine, Seoul National University College of Medicine, Seoul 110-744, South Korea. Electronic address: bjpark@drugsafe.or.kr.
Abstract
BACKGROUND: Propofol is an addictive drug, and the problem of its abuse and dependence has occurred. To compare the safety profiles of propofol and other similar anesthetics such as diazepam, lorazepam, and midazolam, we evaluated their uses and related adverse drug reactions (ADRs) using Korean Adverse Event Reporting System (KAERS) data. METHODS: The domestic consumption data and the ADR reports of four anesthetics from 2008 to 2012 were retrieved. ADR proportions were calculated using defined daily dose/1000 inhabitants/day (DID) for the denominator. The patient's characteristics were compared among the four drugs statistically, and the types of ADRs were analyzed. RESULTS: The consumption and ADR reports increased during the study period, particularly in the cases of propofol and midazolam. Lorazepam showed the highest overall and serious ADR proportions (220.81 reports/DID, 58.47 reports/DID, respectively); however, with respect to death proportion, propofol was the first (19.21 reports/DID). Also, ADRs related to drug addiction were mainly observed in the propofol group. CONCLUSIONS: Four anesthetics were different with regard to the consumption and proportion or the type of ADRs. The use of propofol increased more than 2 times, and propofol showed the highest ADR proportions in death and drug addiction cases among the four anesthetics.
BACKGROUND:Propofol is an addictive drug, and the problem of its abuse and dependence has occurred. To compare the safety profiles of propofol and other similar anesthetics such as diazepam, lorazepam, and midazolam, we evaluated their uses and related adverse drug reactions (ADRs) using Korean Adverse Event Reporting System (KAERS) data. METHODS: The domestic consumption data and the ADR reports of four anesthetics from 2008 to 2012 were retrieved. ADR proportions were calculated using defined daily dose/1000 inhabitants/day (DID) for the denominator. The patient's characteristics were compared among the four drugs statistically, and the types of ADRs were analyzed. RESULTS: The consumption and ADR reports increased during the study period, particularly in the cases of propofol and midazolam. Lorazepam showed the highest overall and serious ADR proportions (220.81 reports/DID, 58.47 reports/DID, respectively); however, with respect to death proportion, propofol was the first (19.21 reports/DID). Also, ADRs related to drug addiction were mainly observed in the propofol group. CONCLUSIONS: Four anesthetics were different with regard to the consumption and proportion or the type of ADRs. The use of propofol increased more than 2 times, and propofol showed the highest ADR proportions in death and drug addiction cases among the four anesthetics.