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Management: Food and Drug Administration (FDA)
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Total 621 results found since Jan 2013.
FDA Issues New Heart Attack, Stroke Risk Warnings for NSAIDs
The Food and Drug Administration has taken new action to strengthen existing warning labels about the increased risk of heart attack or stroke with the use of prescription and over-the-counter nonaspirin nonsteroidal anti-inflammatory drugs.
Source: Caring for the Ages - August 29, 2015 Category: Health Management Authors: Jeff Evans Source Type: news
Stroke recovery in mice improved by Ambien, study shows
Mice that had strokes rebounded significantly faster if they received low doses of a popular sleeping aid, according to researchers. Zolpidem, better known by the trade name Ambien, has long been approved by the U.S. Food and Drug Administration for treating insomnia. But it has never before been definitively shown to enhance recovery from stroke.
Source: ScienceDaily Headlines - December 18, 2015 Category: Science Source Type: news
New reversal agent for factor Xa inhibitors shows promise
Commentary on: Siegal DM, Curnette JT, Connolly SJ, et al.. Andexanet alfa for the reversal of Factor Xa inhibitor activity. N Engl J Med 2015;373:2413–24. Context Direct oral anticoagulants (DOACs) have emerged as alternatives to vitamin K-antagonists (eg, warfarin) for the long-term management of stroke prevention for non-valvular atrial fibrillation or venous thromboembolic disease. Favourable side-effect profiles and absence of therapeutic monitoring are important benefits of these newer agents. Warfarin is readily reversed with fresh frozen plasma (FFP) or prothrombin complex concentrates.1 The first reversal ag...
Source: Evidence-Based Medicine - May 22, 2016 Category: Internal Medicine Authors: Ghadimi, K., Welsby, I. J. Tags: Clinical trials (epidemiology), Immunology (including allergy), Drugs: cardiovascular system, Stroke, Venous thromboembolism, Unwanted effects / adverse reactions Therapeutics/Prevention Source Type: research
FDA allows marketing of clot retrieval devices to reduce disability in stroke patients
The U.S. Food and Drug Administration today allowed marketing of two Trevo clot retrieval devices as an initial therapy for strokes due to blood clots (ischemic) to reduce paralysis, speech difficulties and other stroke disabilities. These devices should be used within six hours of symptom onset and only following treatment with a clot-dissolving drug (tissue plasminogen activator or t-PA), which needs to be given within three hours of symptom onset.
Source: Food and Drug Administration - September 2, 2016 Category: American Health Source Type: news
FDA rejects Eagle Pharmaceuticals' heat stroke treatment
(Reuters) - Eagle Pharmaceuticals Inc said on Tuesday the U.S. Food and Drug Administration declined to approve its drug Ryanodex to treat heat stroke and requested an additional clinical trial.
Source: Reuters: Health - July 26, 2017 Category: Consumer Health News Tags: healthNews Source Type: news
FDA Approves Amgen's Repatha ® (evolocumab) To Prevent Heart Attack And Stroke
Following FDA Priority Review, Repatha is the Only PCSK9 Inhibitor Approved to Reduce Risk of Heart Attack, Stroke and Coronary Revascularization
THOUSAND OAKS, Calif., Dec. 1, 2017 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that following priority review of its supplemental Biologics License Application, the U.S. Food and Drug Administration (FDA) approved Repatha® (evolocumab) as the first PCSK9 inhibitor to prevent heart attacks, strokes and coronary revascularizations in adults with established cardiovascular disease.1
"We are pleased that the FDA made the inclusion of our outcomes data a priority ...
Source: Amgen News Release - December 1, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
How is edaravone effective against acute ischemic stroke and amyotrophic lateral sclerosis?
Authors: Watanabe K, Tanaka M, Yuki S, Hirai M, Yamamoto Y
Abstract
Edaravone is a low-molecular-weight antioxidant drug targeting peroxyl radicals among many types of reactive oxygen species. Because of its amphiphilicity, it scavenges both lipid- and water-soluble peroxyl radicals by donating an electron to the radical. Thus, it inhibits the oxidation of lipids by scavenging chain-initiating water-soluble peroxyl radicals and chain-carrying lipid peroxyl radicals. In 2001, it was approved in Japan as a drug to treat acute-phase cerebral infarction, and then in 2015 it was approved for amyotrophic lateral sclerosi...
Source: Journal of Clinical Biochemistry and Nutrition - January 28, 2018 Category: Nutrition Tags: J Clin Biochem Nutr Source Type: research
FDA permits marketing of clinical decision support software for alerting providers of a potential stroke in patients
Source: Food and Drug Administration - February 13, 2018 Category: American Health Source Type: news
FDA Permits Marketing of Clinical Decision Support Software for Alerting Providers of a Potential Stroke in Patients
Today, the U.S. Food and Drug Administration permitted marketing of the Viz.AI Contact application, a type of clinical decision support software designed to analyze computed tomography (CT) results that may notify providers of a potential stroke in their patients.
Source: eHealth News EU - February 13, 2018 Category: Information Technology Tags: Featured Industry Business and Industry Source Type: news
FDA expands treatment window for use of clot retrieval devices in certain stroke patients
FDA expands treatment window for use of clot retrieval devices in certain stroke patient
Source: Food and Drug Administration - February 15, 2018 Category: American Health Source Type: news
FDA Drug Safety Communication: FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin
[05-13-2014] In its ongoing review of the blood thinner Pradaxa (dabigatran), the U.S. Food and Drug Administration (FDA) recently completed a new study in Medicare patients comparing Pradaxa to an older blood thinner, warfarin, for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death.
Source: FDA Center for Drug Evaluation and Research - What's New - February 26, 2018 Category: Drugs & Pharmacology Source Type: news
From stroke to neurodegenerative diseases: The multi-target neuroprotective effects of 3-n-butylphthalide and its derivatives
Publication date: Available online 11 August 2018Source: Pharmacological ResearchAuthor(s): Longjian Huang, Shan Wang, Fei Ma, Yong Zhang, Yuchen Peng, Changhong Xing, Yipu Feng, Xiaoliang Wang, Ying PengAbstractDiscovering effective agents to slow or stop neurodegeneration is a challenging task. Over decades, only a few drugs were approved by Food and Drug Administration (FDA) and most ended in failure. The lessons learned have switched the strategy of drug discovery from designing highly selective ligands to a network pharmacology approach. This enables many natural products like butylphthalide (NBP) once again to be reg...
Source: Pharmacological Research - August 11, 2018 Category: Drugs & Pharmacology Source Type: research
FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab)
The U.S. Food and Drug Administration (FDA) is warning that rare but serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis (MS) shortly after they received Lemtrada (alemtuzumab).
Source: FDA Center for Drug Evaluation and Research - What's New - November 29, 2018 Category: Drugs & Pharmacology Source Type: news
FDA Approves Praluent (alirocumab) to Prevent Heart Attack, Stroke and Unstable Angina Requiring Hospitalization
PARIS and TARRYTOWN, NY– April 26, 2019– The U.S. Food and Drug Administration (FDA) has approved Praluent (alirocumab) to reduce the risk of heart attack, stroke, and unstable angina requiring hospitalization in adults with...
Source: Drugs.com - New Drug Approvals - April 26, 2019 Category: Drugs & Pharmacology Source Type: news
