scholarly journals Psychiatric Adverse Reactions to Anaplastic Lymphoma Kinase Inhibitors in Non-Small-Cell Lung Cancer: Analysis of Spontaneous Reports Submitted to the FDA Adverse Event Reporting System

2022 ◽  
Author(s):  
Monia Sisi ◽  
Michele Fusaroli ◽  
Andrea De Giglio ◽  
Francesco Facchinetti ◽  
Andrea Ardizzoni ◽  
...  
Keyword(s):  
Adverse Reactions ◽  
Kinase Inhibitors ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Small Cell ◽  
Small Cell Lung ◽  
Event Reporting ◽  
Anaplastic Lymphoma ◽  
Spontaneous Reports

Comparison of Adverse Drug Reactions for Patients Treated with Tyrosine Kinase Inhibitors: Data Mining of the Public Version of the FDA Adverse Event Reporting System (AERS)

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 1698-1698
Author(s):  
Tetsuya Tanimoto ◽  
Yasuo Oshima ◽  
Koichiro Yuji ◽  
Masahiro Kami
Keyword(s):  
Data Mining ◽  
Adverse Event ◽  
Odds Ratio ◽  
Kinase Inhibitors ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Drug Reactions ◽  
Suspected Drug ◽  
Event Reporting

Abstract Abstract 1698 Backgrounds: The consecutive approvals of tyrosine kinase inhibitors (TKIs) have been changing the landscape of treatment strategy for patients with chronic myeloid leukemia (CML). Currently, three TKIs are available worldwide, including imatinib (Glivec/Gleevec; Novartis Pharmaceuticals, East hanover, NJ), nilotinib (Tasigna; Novartis Pharmaceuticals) and dasatinib (Sprycel; Bristol-Myers Squibb, Princeton, NJ). Although second generation TKIs (nilotinib and dasatinib) have shown their efficacy and safety in recent clinical trials, additional data are needed for better understanding and differences in their safety profiles may be helpful when choosing a TKI. We compared the adverse drug reactions (ADRs) for patients treated with three TKIs using spontaneous adverse event reporting after approval to investigate the characteristics of safety profiles. Method: To compare adverse events characteristics among three TKIs, the case/noncase adverse events reports associated with TKIs use were retrieved from the U.S. Food and Drug Administration Adverse Event Reporting System (AERS) between 2004 and 2010. We calculated the reporting odds ratio (ROR), which is known as one of data mining algorithms for signal detection techniques of ADRs, characterized by providing a fast and cost-efficient way of detecting possible ADR signals. All events in the AERS have been coded for data entry in accordance with the standardized terminology, known as Preferred Terms, in the Medical Dictionary for Regulatory Activities. The ROR is similar to the idea of odds ratio, calculating the odds of exposure of the suspected drug in patients who had events divided by the odds of exposure of the suspected drug in those without events. The ROR -1.96 standard error greater than 1 with at least 4 ADR reports was used as a signal criterion in this study. Results: We identified 18,979 ADRs for imatinib, 5,388 ADRs for nilotinib, and 2,482 ADRs for dasatinib. The number of ADRs flagged by our signal criterion was 91 for imatinib, 82 for nilotinib, and 109 for dasatinib. Top 10 lists of ADRs with higher ROR are shown in Table for each TKI. The safety profiles were almost different among TKIs. ADRs related to skin and hepatic function were noted for imatinib, whereas ADRs related to cardiac events were prominent for nilotinib, and ADRs related to lymphocytosis, edema and effusion were noticeable for dasatinib. The different dosing requirements of dasatinib and nilotinib may be an additional factor of ADRs. Conclusions: ADRs reported in the AERS for each TKI were relatively consistent with known characteristics of ADRs reported in previous clinical trials. Our information would be supportive data for choosing a TKI for CML patients based on comorbidities and drug safety profiles. The choice of therapy in a given patient with CML may depend on age, past history and comorbidities as well as disease risk score and mutational analysis. Disclosures: Oshima: Sanofi Aventis: Employment.

scholarly journals Descriptive Analysis of Reported Adverse Events Associated with Antiobesity Medications Using FDA Adverse Event Reporting System (FAERS) Databases 2013-2020

2021 ◽  
Author(s):  
Abdulrahman Alsuhibani ◽  
Marwan Alrasheed ◽  
Musaab Gari ◽  
Ana Hincapie ◽  
Jianfei Guo
Keyword(s):  
Adverse Event ◽  
Cardiovascular Diseases ◽  
Adverse Events ◽  
Reporting System ◽  
Descriptive Analysis ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Event Reporting ◽  
Spontaneous Reports ◽  
Life Threatening

Abstract Background Obesity is a globally growing health problem, and its treatment has been challenging. The usage of antiobesity medications (AOMs) has been associated with severe adverse events (AEs). Spontaneous reports of AOMs can present detailed information about AEs occurring after the time of marketing. Several AOMs have been withdrawn from the market owing to documented AEs. Objective To estimate and characterize the frequency of AEs attributable to the use of the AOMs between January 2013 and June 2020. Setting: US FDA Adverse Event Reporting System (FAERS) between January 01, 2013, and June 31, 2020, Methods A retrospective, descriptive analysis was conducted to analyze all major reported AEs including death, life-threatening, hospitalization, disability, and required intervention or congenital anomaly related to AOMs. The total numbers of AEs reports, cases, adverse reactions and outcomes were calculated for each medication, and patients' mean age and gender were reported. Results We found a total of 18,675 unique AEs reports associated with AOMs used for 15,143 patients. The mean age was 49.8 years [SD 1.83], while most patients were female adults (73.4 %). The main AEs of the safety reports were nausea, headache, cardiovascular diseases, dizziness, drug ineffectiveness, acute kidney failure/ kidney injury, and dry mouth. The FAERS database had 21,229 unique outcomes involving AOMs use, including 1,039 deaths (fatality ratio of 4.9% of all analyzed reports), 1,613 (7.6%) life-threatening events, 7,426 (35%) hospitalizations, and 1,249 (5.9%) disability cases. Phentermine/topiramate fatal cases represent 6% of the overall medication's reported AEs. The cardiovascular AEs were 542 reports (31%) for phentermine, 402 reports (23%) for liraglutide, 381 reports (22%) for phentermine/topiramate. Conclusion Although several AOMs have been withdrawn from the market and replaced with new ones, the utilization of the AOMs is widespread; the FAERS database's analysis revealed many serious AEs in the type of cardiovascular diseases and kidney complications attributable to the use of the AOMs. Therefore, it is necessary to continue and systematically monitor AOMs' safety to help optimize their use.

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