Hemorrhage induced by antithrombotic agents: new insights from a real-world pharmacovigilance study.

BACKGROUND: Hemorrhage represents the most common and serious side effect of antithrombotic agents. Many studies have compared the risk of bleeding between different antithrombotic agents, but analysis of time-to-onset for hemorrhage induced by these drugs is yet sparse. METHODS: We conducted a retrospective study based on the adverse drug reaction reports on antithrombotic agents collected by the Henan Adverse Drug Reaction Monitoring Center. We assessed the reporting odds ratio to determine the disproportionate reporting signals for bleeding and the Weibull shape parameter was used to evaluate the time-to-onset data. RESULTS: In the signal detection, crude low molecular weight heparin-hemorrhage was found as a positive signal. The hemorrhage for most antithrombotic agents was random failure profiles. In particular, the hazard of hemorrhage decreased over time for warfarin and clopidogrel and increased for alteplase, nadroparin, and dipyridamole. CONCLUSION: We found that the risk of bleeding in patients taking Crude low molecular weight heparins was significantly higher compared to other antithrombotic agents, but with a small magnificence, which may be attributed to the severely irrational use of this medication under improper management. Statistics in days, results showed that the risk of bleeding decreased over time for warfarin and clopidogrel and increased for alteplase, nadroparin, and dipyridamole.

Risk factors for oxaliplatin-induced hypersensitivity reaction in patients with colorectal cancer.

OBJECTIVE: Hypersensitivity reactions with oxaliplatin (OXA) have attracted much attention. This study aimed to analyze the risk factors for OXA-induced hypersensitivity reaction in Chinese colorectal cancer patients through a single-center retrospective investigation. METHODS: The information from 459 colorectal cancer patients treated with OXA in a hospital was collected retrospectively to explore the risk factors for OXA-induced hypersensitivity reaction. RESULTS: Among the 459 patients, 47 (10.24% incidence) cases developed hypersensitivity reactions, with a 3.70% incidence of grade III/IV reaction. The main symptoms included itching, flushing, dyspnea, and rash, which mainly involved skin and adnexa, respiratory system, and nervous system. Dexamethasone pretreatment presented no significant effects on the hypersensitivity reaction (P = 0.282). Multivariate analysis indicated that the previous allergic history (odds ratio (OR) 2.553, 95% confidence interval (CI) 1.139-5.721, P = 0.023) and OXA-free interval (OR 3.605, 95% CI 1.909-6.809, P = 0.000) were independent risk factors for OXA-induced hypersensitivity reaction. CONCLUSIONS: The incidence of OXA-induced hypersensitivity reaction in colorectal cancer patients was similar to those reported in other countries. Clinical medical staff should pay close attention to high-risk factors, such as allergic history and patients having OXA-free intervals in order to avoid or alleviate hypersensitivity reactions.

Safety Profile of Antipsychotic Drugs: Analysis Based on a Provincial Spontaneous Reporting Systems Database.

Introduction: Antipsychotic drugs are the main therapy for schizophrenia and have been widely used in mental disorder fields. However, the research on the safety of antipsychotic drugs in the real-world is rare. The purpose of this research is to evaluate the safety of antipsychotic drugs based on real-world data. Methods: ADR reports collected by the Henan Adverse Drug Reaction Monitoring Center from 2016 to 2020 were analyzed. We described the safety of antipsychotic drugs by descriptive analysis and four signal mining methods. Meanwhile, the risk factors for serious adverse reactions of antipsychotics were identified. Results: A total of 3363 ADR reports related to antipsychotics were included. We found that the number of adverse drug reaction reports and the proportion of serious adverse reactions have increased year by year from 2016 to 2020. Most adverse drug reactions occurred within 3 months after taking the medicine. The symptoms caused by typical antipsychotics and atypical antipsychotics were different and dyskinesia was more common in typical antipsychotics. Most patients improved or recovered after treatment or intervention while only one patient had sequelae. Low-level hospitals, psychiatric hospitals, youth, and old age could increase the risk of serious adverse reactions. Four off-label signals were found through signal mining, including amisulpride-pollakiuria, ziprasidone-dyspnoea, quetiapine-urinary incontinence, olanzapine-hepatic function abnormal. Conclusion: We found that most ADRs occurred within 3 months after taking the medicine, so close observation was required for patients during the first 3 months of treatment. The ADRs of antipsychotics involved multiple organ-system damages but were not serious. It might be recommended to take alternative drugs after a serious ADR occurred. The symptoms caused by typical APDs and atypical APDs were different. For patients with typical APDs, dyskinesia was more common and should be given special attention. Statistics showed that low-level hospitals, psychiatric hospitals, youth, and old age were risk factors for serious ADRs. The four off-label signals obtained by signal mining should be paid special attention, including amisulpride-pollakiuria, ziprasidone-dyspnoea, quetiapine-urinary incontinence, and olanzapine-hepatic function abnormal.