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Testosterone Drugs May Be Overused, FDA Warns
WASHINGTON (AP) — The Food and Drug Administration is warning doctors against over-prescribing testosterone-boosting drugs for men, saying the popular treatments have not been established as safe or effective for common age-related issues like low libido and fatigue.
The agency says drugmakers must clearly state in their labeling and promotions that the drugs, currently taken by millions of U.S. men, are only approved to treat low testosterone levels caused by disease or injury, not normal aging. Additionally, the FDA cautioned that the drugs may increase the risk of heart attack, stroke and other cardiovascular problem...
Source: Science - The Huffington Post - March 3, 2015 Category: Science Source Type: news
Life With a TBI: March Is National Brain Injury Awareness Month
I find it strangely interesting that this time last year, as I was enduring the beginning of my life with a TBI, I had no idea that March was National Brain Injury Awareness Month. This year I feel compelled to shout it from the rooftops (or the computer screen)! Over the next few weeks, I intend to share with you stories and journeys of those living with a traumatic brain injury (TBI) or caring for a loved one who is recovering from one. My hope is to educate those who aren't familiar with TBI, and to help other TBI-ers understand that they are not alone, and that their symptoms are not just "in their head" (pun intended)...
Source: Healthy Living - The Huffington Post - March 1, 2015 Category: Consumer Health News Source Type: news
An update on limitations of intravenous thrombolysis to treat acute ischemic stroke.
Abstract
The benefit of intravenous thrombolysis with rt-pa has been demonstrated in acute ischemic stroke up to 4h30 after the first symptoms. The number of patients with stroke treated by rt-pa remains low at less than 5%. In the license of rt-pa in acute ischemic stroke, there are numerous contra-indications explained by the fear of cerebral hemorrhagic complications. These contra-indications are based on the first therapeutic trials published more than 15 years ago, but are not all evidence-based. Large post-marketing registers and new randomized trials have shown a favorable ratio benefit/risk of rt-pa in a...
Source: Presse Medicale - February 16, 2015 Category: Journals (General) Authors: Masingue M, Alamowitch S Tags: Presse Med Source Type: research
Silk Road Medical Announces FDA 510(k) Clearance of the ENROUTE(R) Transcarotid Neuroprotection System
Novel system to protect against stroke via direct carotid access and robust blood flow reversal initiates a new era in carotid revascularization
SUNNYVALE, Calif., Feb. 10, 2015 -- (Healthcare Sales & Marketing Network) -- Silk Road Medical, Inc., a pi... Devices, Interventional, FDASilk Road Medical, Transcarotid Neuroprotection System, carotid stent
Source: HSMN NewsFeed - February 10, 2015 Category: Pharmaceuticals Source Type: news
FDA clears system to reduce stroke risk during stent and angioplasty procedures
The U.S. Food and Drug Administration today cleared for marketing the ENROUTE Transcarotid Neuroprotection System (ENROUTE TNS), for use during a minimally invasive procedure to restore normal blood flow to narrowed carotid arteries. It is the first device designed to access the carotid arteries through an incision in the neck, instead of the groin, and uses a blood flow reversal system to capture pieces of the blockage dislodged during the procedure.
Source: Food and Drug Administration - February 9, 2015 Category: American Health Source Type: news
OPINION: Now Is the Time to Tackle Malnutrition and Its Massive Human Costs
Sadhana Ghimire, 23, makes sure to give her 18-month-old daughter nutritious food, such as porridge containing grains and pulses, in order to prevent stunting. Credit: Mallika Aryal/IPSBy José Graziano da Silva and Margaret ChanROME/GENEVA, Nov 13 2014 (IPS)The scourge of malnutrition affects the most vulnerable in society, and it hurts most in the earliest stages of life. Today, more than 800 million people are chronically hungry, about 11 percent of the global population.Undernutrition is the underlying cause of almost half of all child deaths, and a quarter of living children are stunted due to inadequate nutrition. Mi...
Source: IPS Inter Press Service - Health - November 13, 2014 Category: Global & Universal Authors: Jose Graziano da Silva and Margaret Chan Tags: Advancing Deserts Biodiversity Climate Change Development & Aid Economy & Trade Environment Food & Agriculture Global Global Governance Headlines Health IPS UN: Inside the Glasshouse Population Poverty & MDGs TerraViva United N Source Type: news
Claret Medical Announces First Patient Treated in U.S. Pivotal Trial Evaluating Cerebral Protection During Transcatheter Aortic Valve Replacement (TAVR)
Randomized Controlled SENTINEL Trial is the First in the U.S. to Study Capture and Removal of Debris Released During TAVR That May Otherwise Be the Source of Stroke
SANTA ROSA, Calif.--(Healthcare Sales & Marketing Network)--Claret Medical, Inc., a deve... Devices, Interventional CardiologyClaret Medical, Cerebral Protection, TAVR, transcatheter, aortic valve
Source: HSMN NewsFeed - October 6, 2014 Category: Pharmaceuticals Source Type: news
Hemorrhagic stroke and new oral anticoagulants.
Abstract
The recent release of new oral anticoagulants (NOAC) raises the question of the management of intracranial hemorrhage occurring during treatment with these molecules. Dabigatran, rivaroxaban and apixaban have different pharmacological characteristics that physicians need to know to adjust their prescription to each patient. Studies of efficacy and safety prior to the marketing of these molecules showed a decreased risk of intracranial hemorrhage compared with vitamin K antagonists. However, no reliable data are available regarding the prognosis of these hemorrhages occurring during NOAC treatment. In addi...
Source: Annales Francaises d'Anesthesie et de Reanimation - October 1, 2014 Category: Anesthesiology Authors: Derlon V, Corbonnois G, Martin M, Toussaint-Hacquard M, Audibert G Tags: Ann Fr Anesth Reanim Source Type: research
Keeping the Genie in the Bottle Growth Hormone and Cardiovascular Disease ∗
Anabolic hormone use is increasingly common and includes replacement in patients with hormone deficiencies, questionable uses in those with borderline-low levels, and clear abuses among athletes aiming to gain a competitive advantage. Recently, direct-to-consumer marketing touting the benefits of “low T” treatment has led to increased testosterone use among middle-aged and older men, despite inadequate cardiovascular safety data. Although the Testosterone in Older Men Trial showed improvements in strength among treated patients, it was prematurely halted due to increased cardiovascular events in the treatment arm (1). ...
Source: Journal of the American College of Cardiology: Cardiovascular Interventions - September 29, 2014 Category: Cardiology Source Type: research
Retrospective Safety and Efficacy of the DeepTMS in a variety of pathologies including refractory Major Depression, Bipolar Depression, Parkinsońs Disease, negative symptoms of Schizophrenia and Stroke in a clinical setting; an update on the post-Marketing experience in Chile
Repetitive transcranial magnetic stimulation (rTMS) has been proposed as add-on for the treatment of various pathologies, including refractory Major Depression (MD), Bipolar Depression (BD), Parkinsońs Disease (PD), negative symptoms of Schizophrenia (NS) and Stroke (ST). However, the effectiveness of the conventional rTMS in clinical settings is currently being debated. The novel Deep TMS H-coils can effectively stimulate deeper and larger brain regions than conventional rTMS coils, including the complete thickness of motor and prefrontal cortices, suggesting greater potential clinical efficacy.
Source: BRAIN STIMULATION: Basic, Translational, and Clinical Research in Neuromodulation - September 1, 2014 Category: Neurology Authors: Jimmy Stehberg, Francisco Torres, Esteban Villalón, Raúl Riquelme Tags: Poster Source Type: research
Testing devices for the prevention and treatment of stroke and its complications
We are entering a challenging but exciting period when many new interventions may appear for stroke based on the use of devices. Hopefully these will lead to improved outcomes at a cost that can be afforded in most parts of the world. Nevertheless, it is vital that lessons are learnt from failures in the development of pharmacological interventions (and from some early device studies), including inadequate preclinical testing, suboptimal trial design and analysis, and underpowered studies. The device industry is far more disparate than that seen for pharmaceuticals; companies are very variable in size and experience in str...
Source: International Journal of Stroke - July 17, 2014 Category: Neurology Authors: Philip M. Bath, Michael Brainin, Chloe Brown, Bruce Campbell, Stephen M. Davis, Geoffrey A. Donnan, Gary A. Ford, Werner Hacke, Cynthia Iglesias, Kennedy R. Lees, Stacey S. Pugh, Jeff L. Saver, Peter D. Schellinger, Thomas Truelsen Tags: Opinion Source Type: research
Zynex Appoints Director of Business Development
LONE TREE, CO--(Healthcare Sales & Marketing Network) - Zynex, Inc. (OTCQB: ZYXI), an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, stroke rehabilitation, neurological di... Devices, PersonnelZynex, NeuroDiagnostics
Source: HSMN NewsFeed - June 25, 2014 Category: Pharmaceuticals Source Type: news
Reply Regarding the Effect of Dabigatran Plasma Concentrations
We would like to respond to Dr. Rao's questions concerning our paper (1). First, it is incorrect to state that any data on dabigatran and plasma levels were suppressed. This information has been submitted to all regulatory authorities as part of the original registration process of dabigatran etexilate for reduction of stroke in patients with atrial fibrillation. These data have also been in the public domain since the U.S. Food and Drug Administration (FDA) Advisory Committee meeting in September 2010, before marketing approval (2).
Source: Journal of the American College of Cardiology: Cardiovascular Interventions - June 23, 2014 Category: Cardiology Source Type: research
Poker, marketing strategies might help doctors think better
Stroke doctors might be wise to think about poker players and marketers before making medical decisions, according to an article. "Sadly, more research has gone into how decisions are made when people gamble or buy a car than it has to discovering how doctors make complex decisions," said the lead author. "I think if doctors better understand a poker player's betting strategy or the psychology behind a salesman's tactics, it might change their decision-making process. Doctors might be more encouraged to use tools that would help them make quick, accurate, unbiased decisions when facing difficult clinical scenarios."
Source: ScienceDaily Headlines - May 29, 2014 Category: Science Source Type: news
BOTOX(R) (Botulinum Toxin Type A) Receives a Positive Opinion in Fourteen European Countries for the Treatment of Focal Spasticity of the Ankle in Adult Post Stroke Patients
This Positive Opinion Paves the Way for a Second Indication for BOTOX® in Adult Spasticity Associated with Stroke
MARLOW, England, May 1, 2014 -- (Healthcare Sales & Marketing Network) --Today, Allergan Inc. announced that BOTOX® has received a... Biopharmaceuticals, RegulatoryAllergan, BOTOX, Adult Spasticity, limb spasticity, stroke
Source: HSMN NewsFeed - May 1, 2014 Category: Pharmaceuticals Source Type: news
