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Source: FDA Center for Drug Evaluation and Research - What's New
Management: Food and Drug Administration (FDA)
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Total 7 results found since Jan 2013.
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 Drug Safety Communication: FDA review found no increased cardiovascular risks with Parkinson ’ s disease drug entacapone
[10-26-2015] A Food and Drug Administration (FDA) safety review has found no clear evidence of an increased risk of heart attacks, stroke, or other cardiovascular events associated with the use of entacapone for the treatment of Parkinson ’ s disease.
Source: FDA Center for Drug Evaluation and Research - What's New - March 5, 2018 Category: Drugs & Pharmacology 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
FDA Drug Safety Communication: Pradaxa (dabigatran etexilate mesylate) should not be used in patients with mechanical prosthetic heart valves
The U.S. Food and Drug Administration (FDA) is informing health care professionals and the public that the blood thinner (anticoagulant) Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves.
Source: FDA Center for Drug Evaluation and Research - What's New - February 13, 2018 Category: Drugs & Pharmacology Source Type: news
FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use
[03-03-2015] The U.S. Food and Drug Administration (FDA) cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions.
Source: FDA Center for Drug Evaluation and Research - What's New - December 11, 2017 Category: Drugs & Pharmacology Source Type: news
FDA Drug Safety Communication: FDA review found no increased cardiovascular risks with Parkinson’s disease drug entacapone
[10-26-2015] A Food and Drug Administration (FDA) safety review has found no clear evidence of an increased risk of heart attacks, stroke, or other cardiovascular events associated with the use of entacapone for the treatment of Parkinson’s disease.
Source: FDA Center for Drug Evaluation and Research - What's New - June 21, 2016 Category: Drugs & Pharmacology Source Type: news
FDA Drug Safety Communication: Ongoing Safety Review of Stalevo and possible increased cardiovascular risk
[08-20-2010] The U.S. Food and Drug Administration (FDA) is evaluating clinical trial data that suggest patients taking Stalevo (a combination of carbidopa/levodopa and entacapone) may be at an increased risk for cardiovascular events (heart attack, stroke, and cardiovascular death) compared to those taking carbidopa/levodopa (sold as the combination product, Sinemet).
Source: FDA Center for Drug Evaluation and Research - What's New - March 2, 2016 Category: Drugs & Pharmacology Source Type: news
