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OBJECTIVE To provide reference for clinically safe and rational drug use through mining and analyzing adverse drug event （AE） signals induced by valproic acid （VPA）. METHODS Reporting Odds Ratio （ROR） and Bayesian Confidence Propagation Neural Network （BCPNN） methods of Measures of Disproportionality were performed to mine and analyze the data of VPA-related AE reports in the US FDA Adverse Event Reporting System （FAERS） database from the first quarter of 2013 to the fourth quarter of 2022. RESULTS A total of 1 253 （ROR） and 1 109 （BCPNN） valid signals of preferred terms （PT） were obtained after data processing by the two analysis methods， involving 27 system organs （SOC）， mainly focusing on nervous system disorders， psychiatric disorders， general disorders and administration site conditions. Signals that did not appear in the instruction were associated with 2 SOCs： ear and labyrinth disorders， infections and infestations. CONCLUSIONS As a first-line broad-spectrum anti-epileptic drug， attention should also be paid to eye toxicity and infection risk in the clinical application in addition to paying attention to common adverse events in the instruction.
RESUMO
OBJECTIVE:To mine the ADR signals of dasatinib and imatinib,and to provide reference for safe use of two drugs in clinic. METHODS:ROR and PRR method of disproportionality measures were used to mine the data in the reports about dasatinib and imatinib of 17 quarters from FDA ADE Reporting System during the fourth quarter of 2012-the fourth quarter of 2016. ADR description terms in reports were standardized with international medical terms dictionary. ADR with signal detected by both methods were screened again. RESULTS & CONCLUSIONS:Totally 505 ADR signals for dasatinib and 929 ADR signals for imatinib had been found by ROR and PRR. After re-screening,there were 351 ADR signals for dasatinib and 649 ADR signals for imatinib,including 153 ADR signals for both dasatinib and imatinib. ADR signals for both dasatinib and imatinib obtained in this study were in agreement with known safety information. ADR mainly occurred in gastrointestinal tract,blood and lymphatics,kidney and urinary system,cardiovascular and musculoskeletal tissue,etc. However,incomplete information in the instructions was also found,such as possible urinary system-related ADR signals caused by dasatinib were detected in this study is not mentioned in drug instruction;imatinib could cause ADR signals of left atrium and right atrium dilation,which were not included in their instructions. Common ADRs,such as headaches,metioned in drug instructions of imatinib,did not appear in the top 50 signal intensities in this study. In addition,the ADR of the two drugs also varied,such as 7 ADR signals as periorbital edema and ocular edoma of forimatinib were much stronger than dasatinib;5 ADR signals of dasatinib,such as pericardial effusion and pleural effusion were much stronger than imatinib,indicating clinical drug selection should be based on individual situation of patients.