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Condition: Hemorrhagic Stroke
Management: Food and Drug Administration (FDA)

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Total 40 results found since Jan 2013.

Early Ischemic Blood Brain Barrier Damage: A Potential Indicator for Hemorrhagic Transformation Following Tissue Plasminogen Activator (tPA) Thrombolysis?
Abstract Tissue plasminogen activator (tPA) thrombolysis, remains the only United States Food and Drug Administration(FDA) approvedtreatmentfor acute ischemia stroke. However, the use of tPA has been profoundly constraineddue to its narrow therapeutic time window and the increased risk of potentially deadly hemorrhagic complications. TPA-associated hemorrhagic transformation (HT) often occurs as a result of catastrophic failure of theblood brain barrier (BBB), wherein the affected cerebral capillaries can no longer hold blood constituents.Due to its direct contribution to edema and HT, reperfusion-associated BBB d...
Source: Current Neurovascular Research - May 30, 2014 Category: Neurology Authors: Jin X, Liu J, Liu W Tags: Curr Neurovasc Res Source Type: research

The Efficacy of Rivaroxaban in Patients With Atrial Fibrillation
Atrial fibrillation (AF), the most common form of cardiac arrhythmia, is a major risk factor for cardioembolic stroke. Dose-adjusted warfarin has been the gold standard for stroke prophylaxis in moderate- to high-risk patients with AF. However, the use of warfarin therapy is greatly limited by its narrow therapeutic window, numerous dietary restrictions, and drug–drug interactions, and an increased risk of hemorrhage. As a result, great emphasis has been placed on developing a new anticoagulant agent with fewer risks and limitations. Current data suggest that the oral direct factor Xa inhibitor rivaroxaban is a safe and ...
Source: American Journal of Therapeutics - September 1, 2014 Category: Drugs & Pharmacology Tags: Therapeutic Review Source Type: research

As some hail new antibody treatment for Alzheimer ’s, safety and benefit questions persist
In a packed San Francisco conference room with a celebratory atmosphere, upbeat company representatives and scientists yesterday presented detailed clinical trial data on the first Alzheimer’s treatment shown to clearly, albeit modestly, slow the disease’s normal cognitive decline. The antibody therapy has buoyed a field marked by decades of failures. Now, it appears to be on the cusp of being greenlit by the U.S. Food and Drug Administration (FDA). Yet other researchers warn of potential risks, including brain swelling and brain hemorrhages that were linked to the recently disclosed deaths of two trial participants wh...
Source: Science of Aging Knowledge Environment - December 1, 2022 Category: Geriatrics Source Type: research

MRI for all: Cheap portable scanners aim to revolutionize medical imaging
.news-article__hero--featured .parallax__element{ object-position: 47% 50%; -o-object-position: 47% 50%; } The patient, a man in his 70s with a shock of silver hair, lies in the neuro intensive care unit (neuro ICU) at Yale New Haven Hospital. Looking at him, you’d never know that a few days earlier a tumor was removed from his pituitary gland. The operation didn’t leave a mark because, as is standard, surgeons reached the tumor through his nose. He chats cheerfully with a pair of research associates who have come to check his progress with a new and potentially revolutionary device they are testing. The cylind...
Source: Science of Aging Knowledge Environment - February 23, 2023 Category: Geriatrics Source Type: research

Tissue-type plasminogen activator-binding RNA aptamers inhibiting low-density lipoprotein receptor family-mediated internalisation.
Abstract Recombinant tissue-type plasminogen activator (tPA, trade name Alteplase), currently the only drug approved by the US Food and Drug Administration and the European Medicines Agency for the treatment of cerebral ischaemic stroke, has been implicated in a number of adverse effects reportedly mediated by interactions with the low-density lipoprotein (LDL) family receptors, including neuronal cell death and an increased risk of cerebral haemorrhage. The tissue-type plasminogen activator is the principal initiator of thrombolysis in human physiology, an effect that is mediated directly via localised activation...
Source: Thrombosis and Haemostasis - April 9, 2015 Category: Hematology Authors: Bjerregaard N, Bøtkjær KA, Helsen N, Andreasen PA, Dupont DM Tags: Thromb Haemost Source Type: research

Thrombolysis-Related Hemorrhage
Intravenous tissue plasminogen activator (tPA) improves outcomes when administered within 4.5 hours of symptom onset of ischemic stroke. Symptomatic intracranial hemorrhage (sICH) is the most feared complication after administration of intravenous tPA. The percentage of patients with a good functional outcome after sICH (as defined by the Safe Implementation of Thrombolysis in Stroke-Monitoring Study) following administration of tPA has been shown to be less than 7%, and mortality rates can be greater than 50%. Almost 2 decades after approval of intravenous tPA by the US Food and Drug Administration, our ability to prevent...
Source: JAMA Neurology - October 26, 2015 Category: Neurology Source Type: research

The streptokinase therapy complications and its associated risk factors in patients with acute ...
Acute myocardial infarction (AMI) is one of the main leading causes of mortality and morbidity. Despite the progress in the treatment of AMI, streptokinase is still being used in many countries. Because of the critical condition of patients with AMI and complications of streptokinase therapy, this study was performed to evaluate the pattern of adverse drug reaction (ADRs) induced by streptokinase and its associated risk factors in patients with acute ST elevation MI. A prospective cross-sectional study in a 14-month period was done at the university affiliated referral cardiovascular center. The Naranjo probability scale a...
Source: Iranian Journal of Pharmaceutical Research - December 31, 2017 Category: Drugs & Pharmacology Source Type: research

New Warning for the Multiple Sclerosis Drug Alemtuzumab
The Food and Drug Administration has added a black box warning for alemtuzumab (Lemtrada) stating that the drug, used in the treatment of relapsing multiple sclerosis, may cause ischemic and hemorrhagic stroke and cervicocephalic arterial dissection, rare but serious adverse effects.Nurses should teach patients prescribed this medication to recognize and seek emergency medical care if they develop any signs or symptoms of stroke.
Source: AJN - February 24, 2019 Category: Nursing Tags: Drug Watch Source Type: research

Reply: Association between triple therapy and major adverse cardiovascular events in COPD patients
We thank P. Almagro and P. Martinez-Camblor for their interest in our work and for their salient comments. While we agree that there is no universally accepted definition of major adverse cardiovascular event (MACE), the US Food and Drug Administration (FDA) and the European Medicines Agency include nonfatal myocardial infarction and stroke as well as cardiovascular (CV) mortality in their MACE definition [1]. Importantly, this definition includes both haemorrhagic and ischaemic stroke [1–4]. In our study, we followed this classical "three-point" definition of MACE (including haemorrhagic strokes). While this definit...
Source: European Respiratory Journal - March 2, 2023 Category: Respiratory Medicine Authors: Yang, M.-J., Guo, S.-L., Sin, D. D. Tags: Correspondence Source Type: research

Dabigatran, a Cause of Hematologic Emergency.
Abstract ABSTRACT:: Dabigatran etexilate, a direct thrombin inhibitor, has become an alternative to warfarin for stroke prevention in patients with nonvalvular atrial fibrillation. There remains a concern about its overdose and life-threatening hemorrhage because of unavailability of appropriate coagulation tests to monitor and antidotes to reverse its effects. There are no clinical data about its safety in patients with fluctuating renal function. Multiple bleeding events reported with dabigatran have prompted the U.S. Food and Drug Administration to further investigate these reports. Four clinical cases with lif...
Source: The American Journal of the Medical Sciences - December 5, 2012 Category: Journals (General) Authors: Lal Y, Van Heukelom J Tags: Am J Med Sci Source Type: research

FDA Finds Pradaxa Linked to Lower Stroke, Brain Hemorrhage Risk
A Food and Drug Administration analysis found the blood thinner Pradaxa was better at avoiding strokes and brain hemorrhage, though it was linked to more stomach bleeding.
Source: WSJ.com: Health - May 14, 2014 Category: Pharmaceuticals Tags: PAID Source Type: news

Cardiac Arrest in a 21-Year-Old Man After Ingestion of 1,3-DMAA–Containing Workout Supplement
We describe a case of a young man who took such a supplement and suffered a cardiac arrest. Notably, the product consumed was not on the FDA list of substances containing DMAA. This case highlights the importance for clinicians to be aware of the potential harm of the DMAA-containing products by maintaining a high index of suspicion in otherwise healthy individuals presenting with cardiac arrest. It is of particular importance to sports medicine physicians who are most involved in education and counseling of patients potentially at risk of taking such products.
Source: Clinical Journal of Sport Medicine - December 31, 2014 Category: Sports Medicine Tags: Case Report Source Type: research

The new oral anticoagulants: clinical use and reversal agent development
Warfarin has been the centre of oral anticoagulant therapy for over 60 years. Recent development of new oral anticoagulants (NOACs) has provided a safe and effective alternative for stroke prevention in patients with atrial fibrillation and for prevention of venous thromboembolism. Determination of their use in acute coronary syndrome has been hampered by increases in bleeding events in most large trials, especially when used with antiplatelet therapy. NOACs have equal or superior efficacy and safety profiles compared to warfarin, fewer drug interactions; no dietary restrictions; predictable responses that eliminates moni...
Source: ISBT Science Series - April 13, 2015 Category: Hematology Authors: J. Costin, J. Ansell, S. Bakhru, B. Laulicht, S. Steiner Tags: Invited Review Source Type: research

Cardiovascular safety of albiglutide in the Harmony programme: a meta-analysis
Publication date: Available online 11 August 2015 Source:The Lancet Diabetes & Endocrinology Author(s): Miles Fisher, Mark C Petrie, Philip D Ambery, Jill Donaldson, John J V McMurray, June Ye Background Albiglutide is a glucagon-like peptide-1 receptor agonist, a new class of drugs used to treat type 2 diabetes. We did a prospective meta-analysis of the cardiovascular safety of albiglutide as stipulated by the US Food and Drug Administration recommendations for the assessment of new treatments for diabetes. Methods We did a meta-analysis of eight phase 3 trials and one phase 2b trial in which patients wer...
Source: The Lancet Diabetes and Endocrinology - August 12, 2015 Category: Endocrinology Source Type: research