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Management: Food and Drug Administration (FDA)

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Total 621 results found since Jan 2013.

Evaluation of Prescribing Practices and Outcomes Using Direct-Acting Oral Anticoagulants After Cardiac Surgery
Clin Ther. 2021 May 30:S0149-2918(21)00203-4. doi: 10.1016/j.clinthera.2021.04.009. Online ahead of print.ABSTRACTPURPOSE: Cardiac surgery patients frequently require anticoagulation. Warfarin remains the preferred agent, and a few trials have reported negative outcomes with the use of direct-acting oral anticoagulants (DOACs) in these patients. Therefore, limited literature exists that supports the dosing, safety, and efficacy of DOACs within the cardiac surgery population.METHODS: This single-center, retrospective analysis was conducted at a tertiary academic medical center. All data were extrapolated from electronic med...
Source: Clinical Therapeutics - June 3, 2021 Category: Drugs & Pharmacology Authors: Dareen M Kanaan Bryan M Cook Julie Kelly Rhynn Malloy Source Type: research

Assessing the Health and Economic Impact of a Potential Menthol Cigarette Ban in New York City: a Modeling Study
AbstractMenthol in cigarettes increases nicotine dependence and decreases the chances of successful smoking cessation. In New York City (NYC), nearly half of current smokers usually smoke menthol cigarettes. Female and non-Latino Black individuals were more likely to smoke menthol-flavored cigarettes compared to males and other races and ethnicities. Although the US Food and Drug Administration recently announced that it will ban menthol cigarettes, it is unclear how the policy would affect population health and health disparities in NYC. To inform potential policymaking, we used a microsimulation model of cardiovascular d...
Source: Journal of Urban Health - November 9, 2021 Category: Health Management Source Type: research

Impact of Hospital Volume on Utilization and Outcomes of Sentinel Cerebral Protection System During Transcatheter Aortic Valve Implantation
Stroke remains a serious complication of transcatheter aortic valve implantation (TAVI) with a significant impact on long-term morbidity and mortality. Although the etiology of strokes is multifactorial, most are a result of embolization of debris during the procedure.1 Multiple devices have emerged aiming to reduce the incidence of stroke through cerebral embolic protection. The Sentinel cerebral protection system (CPS) is the only Food and Drug Administration-approved device in the United States.
Source: The American Journal of Cardiology - July 13, 2022 Category: Cardiology Authors: Agam Bansal, Toshiaki Isogai, Mohamed M. Gad, Grant W. Reed, Rishi Puri, Amar Krishnaswamy, Samir R. Kapadia Source Type: research

Performing Transcatheter Left Atrial Appendage Closure: Techniques and Challenges
The left atrial appendage (LAA) has been demonstrated to be the major source of thromboemboli in patients with atrial fibrillation (AF).1 The rationale of LAA closure is based on eliminating LAA continuity with the left atrium thereby reducing stroke risk. Indeed, left atrial appendage occlusion (LAAO) procedures play an important role in anticoagulation-intolerant patients at risk for AF-related stroke. Based on the PROTECT-AF2 and PREVAIL3 studies, the Food and Drug Administration (FDA) approved use of the Watchman (Boston Scientific, MA) device in 2015, with an updated generation of device subsequently ratified in 2020 ...
Source: Heart Rhythm - August 6, 2022 Category: Cardiology Authors: Ammar M. Killu, Mohamad A. Alkhouli Source Type: research

How AI Is Changing Medical Imaging to Improve Patient Care
That doctors can peer into the human body without making a single incision once seemed like a miraculous concept. But medical imaging in radiology has come a long way, and the latest artificial intelligence (AI)-driven techniques are going much further: exploiting the massive computing abilities of AI and machine learning to mine body scans for differences that even the human eye can miss. Imaging in medicine now involves sophisticated ways of analyzing every data point to distinguish disease from health and signal from noise. If the first few decades of radiology were about refining the resolution of the pictures taken of...
Source: TIME: Health - November 4, 2022 Category: Consumer Health News Authors: Alice Park and Video by Andrew D. Johnson Tags: Uncategorized Frontiers of Medicine 2022 healthscienceclimate Innovation sponsorshipblock Source Type: news

FDA Approves Lecanemab, a New Alzheimer ’s Drug
On Jan. 6, the U.S. Food and Drug Administration (FDA) approved a new drug to treat Alzheimer’s disease in its early stages. Lecanemab, which will be available under the name Leqembi, can slow the cognitive decline associated with Alzheimer’s disease by 27%, according to data submitted to the FDA by the drug’s developers, Eisai and Biogen. It’s only the second medication to show any improvement in neurodegeneration, a key criterion in the FDA’s consideration for approval. “For a long time, this is what we have been looking for,” says Dr. Sam Gandy, professor of neurology and psychi...
Source: TIME: Health - January 6, 2023 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized Drugs healthscienceclimate Source Type: news

FDA Experts Vote to Make All COVID-19 Vaccines and Boosters Bivalent
In a unanimous decision, all 21 voting members of the U.S. Food and Drug Administration’s (FDA) vaccine committee recommended that the U.S. start using the same COVID-19 virus strain in all of the COVID-19 vaccines, including primary and booster doses. That means the bivalent booster dose, which targets both the original SARS-CoV-2 strain and the Omicron BA.4/5 strains, would soon become the only type used for all primary shots and boosters. The decision reflects a turning point in the pandemic. Until now, vaccine makers have tried to keep up with constantly evolving variants, but they’ve always been a few step...
Source: TIME: Health - January 27, 2023 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized COVID-19 healthscienceclimate Source Type: news

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

Here ’s an Alternative to Statins for Lowering Cholesterol
Statins have revolutionized heart disease by lowering cholesterol effectively—by up to 50% or more. But anywhere from 7% to 29% of people who take them may be more susceptible to its side effects, which include weakening of muscles and pain, and decide they can’t tolerate them. In a recent study published in JAMA Network Open, for example, researchers at Brigham and Women’s Hospital reported that more than 20% of patients seen at the hospital from 2000 to 2018 who were recommended to take statins refused to take them, and those who refused took three times as long to lower their LDL cholesterol to target ...
Source: TIME: Health - March 4, 2023 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized healthscienceclimate heart health Source Type: news

Can ‘toxic’ bilirubin treat a variety of illnesses?
Generations of medical and biology students have been instilled with a dim view of bilirubin. Spawned when the body trashes old red blood cells, the molecule is harmful refuse and a sign of illness. High blood levels cause jaundice, which turns the eyes and skin yellow and can signal liver trouble. Newborns can’t process the compound, and although high levels normally subside, a persistent surplus can cause brain damage. Yet later this year up to 40 healthy Australian volunteers may begin receiving infusions of the supposedly good-for-nothing molecule. They will be participating in a phase 1 safety trial, sponsored ...
Source: ScienceNOW - June 8, 2023 Category: Science Source Type: news

FDA: Drug to Prevent Blood Clots Approved
From UPI Health News (Business) (December 30, 2012) The U.S. Food and Drug Administration approved the use of the anti-clotting drug Eliquis to reduce the risk of stroke and blood clots, officials say. The FDA said Eliquis, or apixaban, can be...
Source: Drugs.com - Pharma News - January 2, 2013 Category: Pharmaceuticals Source Type: news

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

Families face battle with GSK over dangerous diabetes drug
Exclusive: Pharmaceutical giant resists claims despite settlement with victims in USThousands of families in the UK could be deprived of compensation for the death or harm of a relative caused by the diabetes drug Avandia, even though the British maker has agreed to pay billions of dollars to settle similar claims in the US.The licence for Avandia was revoked in Europe, in September 2010, because of evidence that it could cause heart failure and heart attacks. The drug can still be prescribed in the US, but not to patients at risk of heart problems.A scientist with the Food and Drug Administration estimated that Avandia co...
Source: Guardian Unlimited Science - January 29, 2013 Category: Science Authors: Sarah Boseley Tags: The Guardian United States World news Pharmaceuticals industry Medical research Legal aid Law UK news Diabetes GlaxoSmithKline Business Source Type: news

Fatal dabigatran toxicity secondary to acute renal failure
We describe the case of a 74-year-old man taking dabigatran 150 mg twice daily for atrial fibrillation who presented to the emergency department after 20 mL of hematemesis at home. Laboratory evaluation revealed a partial thromboplastin time of 99 seconds, international normalized ratio of 11.7, and creatine of 3.1 mg/dL (baseline creatine, 0.9 mg/dL). Upper endoscopy revealed diffuse gastritis and bleeding. Despite treatment with packed red blood cells and fresh frozen plasma, the patient's hematemesis persisted resulting in significant aspiration requiring endotracheal intubation. Per poison control center recommendation...
Source: The American Journal of Emergency Medicine - November 19, 2012 Category: Emergency Medicine Authors: Joseph K. Maddry, Mana Kouros Amir, Daniel Sessions, Kennon Heard Tags: Case Reports Source Type: research