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Specialty: Drugs & Pharmacology
Management: European Medicines Agency (EMA)

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Total 6 results found since Jan 2013.

A Post-Authorization Safety Study of Quetiapine as Antidepressant Treatment in Sweden: Nested Case –Control Analyses of Select Outcomes
ConclusionRisks for all-cause mortality, self-harm and suicide, and stroke in older patients may be higher among patients treated with quetiapine and antidepressant combination therapy.
Source: Drug Safety - December 16, 2019 Category: Drugs & Pharmacology Source Type: research

Preventable Cases of Oral Anticoagulant-Induced Bleeding: Data From the Spontaneous Reporting System
Conclusion: Our findings describe the most reported risk factors for preventability of oral anticoagulant-induced bleedings. These factors may be useful for targeting interventions to improve pharmacovigilance activities in our regional territory and to reduce the burden of medication errors and inappropriate prescription. Introduction Oral anticoagulant therapy is widely used for the prevention of stroke and systemic embolism in patients with atrial fibrillation, or for the prevention and treatment of deep vein thrombosis and pulmonary embolism (Raj et al., 1994; Monaco et al., 2017). Oral anticoagulants can be di...
Source: Frontiers in Pharmacology - April 29, 2019 Category: Drugs & Pharmacology Source Type: research

Edaravone: a new hope for deadly amyotrophic lateral sclerosis.
This article discusses the preclinical pharmacology, pharmacokinetics, safety profile, clinical studies and drug interactions of edaravone (Radicava) in ALS. PMID: 29998226 [PubMed - in process]
Source: Drugs of Today - July 13, 2018 Category: Drugs & Pharmacology Tags: Drugs Today (Barc) Source Type: research

Controversial Effects of Exogenous Testosterone on Cardiovascular Diseases
The use of testosterone (T) among men aged 40 years or older was increased more than 3 times from 0.81% in 2001 to 2.91% in 2011. Until recently, the majority of the studies did not show any increased cardiovascular (CV) risk by using T in male patients with hypogonadism. What is more, some studies had observed a protective effect of using T against CV diseases. However, in 2010, a randomized clinical trial (RCT) was intended to study the advantage of T gel in older men with limitations in mobility; the study was stopped due to unexpected high prevalence of CV adverse outcome. These findings were confirmed by 2 other studi...
Source: American Journal of Therapeutics - November 1, 2016 Category: Drugs & Pharmacology Tags: Original Articles Source Type: research

Cardiovascular Morbidity and Pure Red Cell Aplasia Associated With Epoetin Theta Therapy in Patients With Chronic Kidney Disease: A Prospective, Noninterventional, Multicenter Cohort Study.
Abstract PURPOSE: The European Medicines Agency recommends limiting the hemoglobin (Hb) concentration to 10 to 12 g/dL in adults with chronic kidney disease (CKD) receiving erythropoiesis-stimulating agents such as epoetin theta. This postauthorization study assessed the incidence and intensity of cardiovascular events, including ischemic stroke, in patients receiving epoetin theta for anemia associated with CKD. A secondary end point was adverse drug reactions, including pure red cell aplasia. METHODS: In this prospective, noninterventional, multinational cohort study, consecutive patients with advanced or e...
Source: Clinical Therapeutics - December 18, 2015 Category: Drugs & Pharmacology Authors: Lammerich A, Balcke P, Bias P, Mangold S, Wiesholzer M Tags: Clin Ther Source Type: research

Eliquis receives ‘positive opinion’ from EMA
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended an addition to the current Summary of Product Characteristics (SmPC) and stated that ‘Patients can stay on apixaban while being cardioverted.’
Source: Pharmacy Europe - May 15, 2014 Category: Drugs & Pharmacology Authors: AMcculloch Tags: Cardiovascular medicine apixaban ARISTOTLE Eliquis Latest News non-valvular atrial fibrillation stroke systemic embolism Source Type: news