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Showing posts from January, 2013

U.S. Approves Health Exchanges in Four Republican-Governed States

WASHINGTON (Reuters) Jan 03 - U.S. officials on Thursday gave four states currently governed by Republicans the green light to set up their own health insurance exchanges under President Barack Obama's healthcare reform law, an initiative largely opposed by Republicans. The U.S. Department of Health and Human Services said Idaho, Nevada, New Mexico and Utah joined a list totaling 17 states and the District of Columbia that have all won conditional approval to establish their own state exchanges, with operations set to begin on January 1, 2014. A fifth Republican-governed state, Mississippi, applied to operate a state exchange, but has not received approval because of a dispute about how much authority state officials should exercise over the operations of its prospective online marketplace, officials said. The U.S. administration also cleared an exchange that Arkansas plans to run in partnership with the federal government. Delaware received approval for a similar partners

Many Patients Unaware of Radiation Risk From CT Scans

By Genevra Pittman NEW YORK (Reuters Health) Jan 03 - One-third of people getting a CT scan didn't know the test exposed their body to radiation, in a new study from a single U.S. medical center. The majority of patients also underestimated the amount of radiation delivered by a CT scan, and just one in 20 believed the scan would increase their chance of ever getting cancer. The study's lead researcher, Janet Busey, said doctors need to do a better job of talking to patients about the risks and benefits of the tests, including about radiation exposure. One challenge is that there is still debate within the medical community about just how much long term cancer risk the scans carry, she said. That risk also depends on how many scans a patient gets and which organs are exposed to radiation. "There's no doubt, CT saves lives," Busey, from the University of Washington in Seattle, told Reuters Health. And their benefits usually outweigh their risks, she ad

GI Bleeds: Withholding Transfusions Boosts Survival

Withholding transfusions until hemoglobin levels are lower than 7%, rather than 9%, improves overall survival by 45% in patients with acute upper gastrointestinal (GI) bleeding, according to a  study published  in the January 3 issue of the New England Journal of Medicine . "[This study] provides long-awaited evidence to guide practice and justify current recommendations for the management of upper gastrointestinal bleeding," asserts Loren Laine, MD, from the Yale University School of Medicine in New Haven and the VA Connecticut Healthcare System in West Haven, in an accompanying editorial . Although prior meta-analyses have largely excluded the potential for benefit with a liberal transfusion strategy, only 1% or less of included patients had acute GI bleeds, Dr. Laine writes. To examine the potential benefit of a more narrow approach, CĂ ndid Villanueva, MD, from the Gastrointestinal Bleeding Unit, Department of Gastroenterology, Hospital de Sant Pau, Autonomous Uni

No Increased Risk of Neurologic Complications With Transradial PCI

STOKE-ON-TRENT, United Kingdom  — Performing PCI via the radial artery does not increase the risk of neurological complications when compared with conventional transfemoral PCI, a new European analysis shows [1]. Researchers say the results are reassuring, given that more and more operators are beginning to switch over to the transradial approach for various procedures. "This analysis of almost 350 000 PCI procedures has not found any increase in the risk of neurologic complications associated with transradial access via either the right (the predominant radial artery used) or left radial artery," write Dr Karim Ratib  (University Hospital of North Staffordshire, Stoke-on-Trent, UK) and colleagues in their study, published online December 26, 2012 in the  American Heart Journal . "The results are reassuring, as the data were collected over a transitional period in UK access-site practice, during which transradial access increased from 17.1% to 50.8% of all PCI cases

Semantic Decision-Making Corrupted in MCI, AD

Patients with mild cognitive impairment (MCI) and Alzheimer's disease (AD) are consistently slower and less accurate than healthy control persons in making semantic decisions in response to stimuli with words and images, new research shows. Brady Kirchberg and colleagues at Hofstra North Shore–Long Island Jewish School of Medicine, Manhasset, New York, found that both MCI and AD groups were not only less accurate and slower than healthy control participants in making semantic decisions in response to word stimuli but also that the deficit worsened as the sizes of the objects being compared became more similar. When line drawings were used as stimuli, the size of the drawings themselves had an undue influence upon semantic knowledge judgments in the 2 groups, investigators add. Performance on the semantic distance task was also a "strong and significant" predictor of everyday functional capacity. Dr. Terry Goldberg "When MCI/AD patients have to

Dexpramipexole Fails in ALS

Biogen Idec reports that topline results of a phase 3 trial investigating dexpramipexole in patients with amyotrophic lateral sclerosis (ALS) failed to show a benefit on primary or secondary outcomes. The trial, called EMPOWER and including 943 patients with ALS, failed to meet the primary outcome, a joint rank analysis of function and survival called the Combined Assessment of Function and Survival. Other endpoints, including functional decline, survival, or respiratory decline, and subgroup analyses also failed to show efficacy with treatment, overall or for any subpopulation. "Based on these results, Biogen Idec will discontinue development of dexpramipexole in ALS," a statement from the company said. "We share the disappointment of members of the ALS community, who had hoped that dexpramipexole would offer a meaningful treatment option," Douglas E. Williams, PhD, executive vice president of research and development at Biogen Idec, said in the company st

Unnecessary Pap Tests in Millions of US Women

In their  report  on cervical cancer screening released yesterday, the Centers for Disease Control and Prevention (CDC) startlingly estimated that 22 million women in the United States may have undergone such screening unnecessarily, because they had already had hysterectomies. An expert approached by  Medscape Medical News  to comment on the issue cautioned that the data collected by the CDC were from women self-reporting and so may be subject to bias. She also suggested that some of the unnecessary testing, which is contrary to guidelines that have been in place for a decade, may be due to confusion stirred up by educational campaigns for the human papilloma virus vaccine Gardasil (Merck & Co). The CDC analyzed data collected from 2000-2010 by the Behavioral Risk Factor Surveillance System on screening for cervical cancer using the Papanicolaou (Pap) test. In one of the articles published in  Morbidity and Mortality Weekly Report , the CDC highlighted the fact that durin

Depression Not Likely to Cause Cognitive Impairment

A new study suggests that depression often accompanies cognitive impairment but does not precede it. "Traditionally, cognitive complaints and impairment in the presence of depression has been considered to be caused by the depression. Our study suggests that depression is not a cause of dementia but accompanies the onset of cognitive impairment," JosĂ© Alejandro Luchsinger, MD, MPH, associate professor of medicine and epidemiology, Columbia University Medical Center, New York City, told  Medscape Medical News . The study was  published online  December 31, 2012 in  Archives of Neurology . Transition Time Crucial Period Patients with mild cognitive impairment (MCI) and Alzheimer's disease (AD) often have depressive symptoms, but the mechanisms underlying the association remain unclear. "Depression could be a risk factor for dementia, an early dementia symptom, a reaction to cognitive and functional disability, or a symptom of a related risk factor, such as

Catheter Disinfection Caps Cut Infection Rates

Central line–associated bloodstream infections (CLABSIs) declined sharply during a study that tested alcohol-impregnated disinfection caps with catheters in place of the standard scrubbing protocol. The suburban Chicago hospitals involved in the study have since adopted the use of the cap as standard practice. Marc-Oliver Wright, MT, MS, CIC, from the Department of Infection Control, NorthShore University Health Systems, Evanston, Illinois, and colleagues reported their results in an article published  in the January issue of the  American Journal of Infection Control . The investigators conducted a 3-phase quasi-experimental study of adults with central lines installed at 3 hospitals in 2009: first with standard scrub protocol, second (intervention) with the cap used, and third with standard scrub used again. At a fourth hospital, they tested just the intervention because of limited resources. The plastic-threaded cap houses a sponge saturated with 70% isopropyl alcohol. The

Mothers May Be Key Source of LOD Strep in Neonates

Mothers appear to be the source of most neonatal group B Streptococcus  (GBS) late-onset disease (LOD) infections, according to a the results of a prospective cohort study. In addition, preterm neonates have a high rate (1.4/1000 births) of group B  Streptococcus  (GBS) late-onset disease (LOD). They also carry the highest rate of mortality. Intrapartum antibiotics are associated with milder LOD (mild vs severe;  P  = .03) and delayed presentation of symptoms. Alberto Berardi, MD, from the Azienda Ospedaliero-Universitaria Proclinico in Moddena, Italy, and colleagues published the results of their online January 7 in  Pediatrics . They evaluated GBS-LOD infections during an 8-year period between 2003 and 2010. The study included a high percentage of preterm newborns. LOD primarily presented as sepsis, meningitis, and/or focal infection. The investigators found that the earlier the presentation of LOD, the higher the risk for meningitis and death. Approximately 50% of the prete

Drug Information Update - FDA approves Eliquis to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation‏

On December 28, 2012, the U.S. Food and Drug Administration approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem. Atrial fibrillation, one of the most common types of abnormal heart rhythm, is an abnormal, irregular, and rapid beating of the heart in which the heart’s two upper chambers (atria) do not contract properly, allowing blood clots to form in them. These clots can break off and travel to the brain or other parts of the body.

New and Generic Drug Approvals

December 31, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Disulfiram disulfiram Tablet; Oral Vintage Pharms Approval Fulyzaq crofelemer Tablet, Delayed Release; Oral Salix Pharms Approval Pregabalin pregabalin Capsule; Oral Sandoz Inc Tentative Approval Rizatriptan Benzoate rizatriptan benzoate Tablet; Oral Teva Pharms Approval Rizatriptan Benzoate rizatriptan benzoate Tablet, Orally Disintegrating; Oral Mylan Pharma Approval Rizatriptan Benzoate rizatriptan benzoate Tablet; Oral Sandoz Approval Rizatriptan Benzoate rizatriptan benzoate Tablet; Oral Natco Pharma Ltd Approval Rizatriptan Benzoate rizatriptan benzoate Tablet; Oral Glenmark Generics Approval Rizatriptan Benzoate rizatriptan benzoate Tablet; Oral Mylan Pharms Inc Approval Rizatriptan Benzoate rizatriptan benzoate Tablet; Oral Sun Pharma Global Approval Rizatriptan Benzoate rizatriptan benzoate Tablet; Oral Apotex Corp Approval Rizatriptan Benzoate rizatriptan benzoate Tablet;

New and Generic Drug Approvals

January 3, 2013 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Aleve naproxen sodium Tablet; Oral Bayer Manufacturing Change or Addition Ondansetron Hydrochloride Preservative Free ondansetron hydrochloride Injectable; Injection Emcure Pharms Ltd Approval Prozac fluoxetine hydrochloride Capsule; Oral Eli Lilly and Co Labeling Revision Prozac Weekly fluoxetine hydrochloride Capsule, Delayed Rel Pellets; Oral Lilly Labeling Revision Sarafem fluoxetine hydrochloride Capsule; Oral Eli Lilly and Co Labeling Revision Symbyax fluoxetine hydrochloride; olanzapine Capsule; Oral Lilly Labeling Revision