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

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Total 40 results found since Jan 2013.

Dabrafenib Plus Trametinib for BRAF V600E-Mutant Non-small Cell Lung Cancer: A Patient Case Report
We report the case of a 70-year-old Asian woman (never smoker) who was diagnosed with lung adenocarcinoma in May 2014. Testing at diagnosis was negative for programmed death ligand 1 orEGFR,ALK, andROS1 alterations. She was started on carboplatin-pemetrexed-bevacizumab and maintenance bevacizumab but progressed in September 2015. Subsequently, she progressed on second-line nivolumab and third-line docetaxel. In March 2016, pleural fluid obtained at diagnosis tested positive for theBRAF V600E mutation and she received dabrafenib plus trametinib. She experienced rapid tumor shrinkage and symptom improvement and became able t...
Source: Clinical Drug Investigation - June 26, 2019 Category: Drugs & Pharmacology Source Type: research

Percutaneous devices for left atrial appendage occlusion: A contemporary review.
Abstract Patient with atrial fibrillation (AF) are at risk of developing stroke with the left atrial appendage (LAA) being the most common site for thrombus formation. If left untreated, AF is associated with 4 to 5 folds increase in the risk of ischemic stroke in all age groups. About 5% to 15% of AF patients have atrial thrombi on transesophageal echocardiography, and 91% of those thrombi are located in the LAA in patient with nonrheumatic AF. Although oral anticoagulants are the gold-standard treatment for stroke prevention in patients with non-valvular AF, some patients are at high risk of bleeding and deemed ...
Source: World Journal of Cardiology - February 25, 2019 Category: Cardiology Authors: Moussa Pacha H, Al-Khadra Y, Soud M, Darmoch F, Moussa Pacha A, Alraies MC Tags: World J Cardiol 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

Effect of Clot Stiffness on Recombinant Tissue Plasminogen Activator Lytic Susceptibility in Vitro
The lytic recombinant tissue plasminogen activator (rt-PA) is the only drug approved by the Food and Drug Administration for treating ischemic stroke. Less than 40% of patients with large vessel occlusions who are treated with rt-PA have improved blood flow. However, up to 6% of all patients receiving rt-PA develop intracerebral hemorrhage. Predicting the efficacy of rt-PA treatment a priori could help guide therapeutic decision making, such that rt-PA is administered only to those individuals who would benefit from this treatment.
Source: Ultrasound in Medicine and Biology - September 26, 2018 Category: Radiology Authors: Karla P. Mercado-Shekhar, Robert T. Kleven, Hermes Aponte Rivera, Ryden Lewis, Kunal B. Karani, Hendrik J. Vos, Todd A. Abruzzo, Kevin J. Haworth, Christy K. Holland Tags: Original Contribution 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 - February 28, 2018 Category: Drugs & Pharmacology Source Type: research

Relevance of the Updated Food and Drug Administration Alteplase Label for Acute Ischemic Stroke: The Estimated Impact and Current Guidelines.
Abstract In 2015, the Food and Drug Administration updated the contraindications for the use of alteplase in acute ischemic stroke (AIS), potentially creating a greater impact on treatment. A history of intracranial hemorrhage and recent stroke within 3 months were removed as contraindications, increasing the number of patients eligible for alteplase. The aim of this commentary is to call attention to the updates and discuss them relative to current American Heart Association/American Stroke Association guidelines. Additionally, we estimate the clinical impact of the updates by analyzing AIS admissions to a large-...
Source: The Annals of Pharmacotherapy - January 1, 2018 Category: Drugs & Pharmacology Authors: Shiue HJ, Albright KC, Sands KA Tags: Ann Pharmacother 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

Hemorrhagic Stroke in a Young Healthy Male Following Use of Pre-Workout Supplement Animal Rage XL.
Authors: Harris BF, Winn C, Ableman TB Abstract So-called "pre-workout" supplements are substances marketed as natural dietary supplements with claims of helping athletes achieve more focused and intense workouts. The use of such products remains popular among American youth as a whole, but is especially high among active duty service members. Supplements are minimally regulated by the Food and Drug Administration (FDA), and unlike pharmaceuticals, supplements are often brought to market without any testing to show neither efficacy nor safety. Several case reports have documented serious adverse events and raise th...
Source: Military Medicine - September 10, 2017 Category: International Medicine & Public Health Tags: Mil Med Source Type: research

All bleeding stops — but does idarucizumab (Praxbind) make it stop faster?
3.5 out of 5 stars Persistent life-threatening hemorrhage after administration of idarucizumab. Alhashem HM et al. Am J Emerg Med 2016 June 30 [Epub ahead of print] Reference Dabigatran (Pradaxa) is a direct thrombin inhibitor approved for stroke and embolism prophylaxis in patients with non-valve-related atrial fibrillation. When it was first released in 2008, a major disincentive to widespread use was the lack of a reliable reversal agent to treat major bleeds, or to administer before necessary invasive procedures. In October 2015, the U.S. Food and Drug Administration approved idarucizumab (Praxbind), a monoclonal ant...
Source: The Poison Review - July 27, 2016 Category: Toxicology Authors: Leon Gussow Tags: Medical anticoagulant hemorrhage idarucizumab pradaxa praxbind reversal agent Source Type: news

Validation of TURN, a simple Predictor of Symptomatic Intracerebral Hemorrhage after IV Thrombolysis
Intravenous thrombolysis (rt-PA) remains the only medical treatment for acute ischemic stroke approved by the Food and Drug Administration (FDA), but carries a substantial risk for symptomatic intracerebral hemorrhage (sICH) [1]. Predictive scores for sICH may help improve the safety profile for rt-PA treatment.
Source: Clinical Neurology and Neurosurgery - April 21, 2016 Category: Neurosurgery Authors: David Asuzu, Karin Nystrӧm, Hardik Amin, Joseph Schindler, Charles Wira, David Greer, Nai Fang Chi, Janet Halliday, Kevin N. Sheth 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

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

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

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

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