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The Gluten-Free Labeling Rule: What Registered Dietitian Nutritionists Need to Know to Help Clients with Gluten-Related Disorders
On August 5, 2013, the US Food and Drug Administration (FDA) published the final rule on gluten-free labeling.1 This rule defines the claim gluten-free when voluntarily used on food labels. The rule went into effect on September 4, 2013, and had a compliance date of August 5, 2014. All products labeled on or after August 5, 2014, bearing a gluten-free claim on product packaging that fall under the labeling jurisdiction of the FDA must be in compliance. Consumers and registered dietitian nutritionists (RDNs) should be mindful that products labeled before the compliance date may be on store shelves for a period of time. (Sou...
Source: Journal of the American Dietetic Association - December 19, 2014 Category: Nutrition Authors: Tricia Thompson Tags: Practice Applications Source Type: research

FDA abuse-deterrent guidance. Assessing new technologies
Aims: To provide an overview of the Food and Drug Administration (FDA) current experience on the evaluation of the properties of novel abuse deterrent (AD) formulations. (Source: Drug and Alcohol Dependence)
Source: Drug and Alcohol Dependence - December 18, 2014 Category: Addiction Authors: Silvia N. Calderon, J.M. Tolliver, Michael Klein Source Type: research

Imaging atlas for eligibility and on-study safety of potential shoulder adverse events in anti-NGF studies (Part 3)
Despite promising results, the U.S. Food and Drug Administration (FDA) put on hold trials assessing anti-nerve growth factor (a-NGF) compounds due to concerns over accelerated rates of OA progression. The mechanism of these events is unclear but joint adverse events were observed particularly in patients using a-NGFs in combination with non-steroidal anti-inflammatory drugs (NSAIDs), suggesting that the significantly greater analgesic effect of these separate classes of drugs prompted patients to permit increased joint load without experiencing the usual pain that would limit joint stress. (Source: Osteoarthritis and Cartilage)
Source: Osteoarthritis and Cartilage - December 18, 2014 Category: Rheumatology Authors: F.W. Roemer, C.W. Hayes, C.G. Miller, K. Hoover, A. Guermazi Source Type: research

Imaging atlas for eligibility and on-study safety of potential knee adverse events in anti-NGF studies (Part 1)
Monoclonal antibodies that bind and inhibit nerve growth factor (NGF) have demonstrated both, good analgesic efficacy and improvement in function in patients with osteoarthritis (OA). Despite initial promising data, trials in OA had been suspended by the Federal Food and Drug Administration (FDA) due to concerns over accelerated rates of OA progression. Imaging will play a crucial role in future clinical trials to define eligibility of potential participants and to monitor safety during the course of these studies. (Source: Osteoarthritis and Cartilage)
Source: Osteoarthritis and Cartilage - December 18, 2014 Category: Rheumatology Authors: F.W. Roemer, C.W. Hayes, C.G. Miller, K. Hoover, A. Guermazi Source Type: research

A review of the pharmacology and clinical application of alfaxalone in cats
Publication date: Available online 16 December 2014 Source:The Veterinary Journal Author(s): Leon N. Warne , Thierry Beths , Ted Whittem , Jennifer E. Carter , Sébastien H. Bauquier Alfaxalone-2-hydroxpropyl-β-cyclodextrin (alfaxalone-HPCD) was first marketed for veterinary use in Australia in 2001 and has since progressively became available throughout the world, including the USA, where in 2012 Food and Drug Administration (FDA) registration was granted. Despite the growing body of published works and increasing global availability of alfaxalone-HPCD, the accumulating evidence for its use in cats has not been thoroug...
Source: The Veterinary Journal - December 18, 2014 Category: Veterinary Research Source Type: research

Environmental exposure chambers in allergen immunotherapy trials: Current status and clinical validation needs
As required by the European Medicines Agency and the US Food and Drug Administration for pivotal trials involving allergen immunotherapy (AIT) products, clinical efficacy assessment is currently based on double-blind, placebo-controlled field studies with natural allergen exposure during the allergen season. However, this study design is associated with several drawbacks, such as the high variability of allergen exposure in different trial sites or seasons and the presence of confounding environmental factors. (Source: Journal of Allergy and Clinical Immunology)
Source: Journal of Allergy and Clinical Immunology - December 18, 2014 Category: Allergy & Immunology Authors: Karen Rösner-Friese, Susanne Kaul, Stefan Vieths, Oliver Pfaar Source Type: research

[Research Articles] A rapid antimicrobial susceptibility test based on single-cell morphological analysis
We describe a novel AST called single-cell morphological analysis (SCMA) that can determine antimicrobial susceptibility by automatically analyzing and categorizing morphological changes in single bacterial cells under various antimicrobial conditions. The SCMA was tested with four Clinical and Laboratory Standards Institute standard bacterial strains and 189 clinical samples, including extended-spectrum β-lactamase–positive Escherichia coli and Klebsiella pneumoniae, imipenem-resistant Pseudomonas aeruginosa, methicillin-resistant Staphylococcus aureus, and vancomycin-resistant Enterococci from hospitals. The r...
Source: Science Translational Medicine - December 17, 2014 Category: Biomedical Science Authors: Choi, J., Yoo, J., Lee, M., Kim, E.-G., Lee, J. S., Lee, S., Joo, S., Song, S. H., Kim, E.-C., Lee, J. C., Kim, H. C., Jung, Y.-G., Kwon, S. Tags: Research Articles Source Type: research

Discrepancies in Liver Disease Labeling in the Package Inserts of Commonly Prescribed Medications
Each drug approved by regulatory authorities for human use is accompanied by a package insert, also known as “prescribing information” in the United States and the “patient information” leaflet in Europe, which provides its salient features in a structured format. Although pharmaceutical companies submit the summary of product characteristics, the Food and Drug Administration in the United States and the European Medicines Agency in Europe are responsible for reviewing and publishing the content of these package inserts. (Source: Gastroenterology)
Source: Gastroenterology - December 17, 2014 Category: Gastroenterology Authors: Einar S. Bjornsson, Elin I. Jacobsen, R. Einarsdottir, Naga Chalasani Tags: Commentary Source Type: research

Impact of Pathologists and Evaluation Methods on Performance Assessment of the Kidney Injury Biomarker, Kim-1.
Abstract Attempts to characterize and formally qualify biomarkers for regulatory purposes have raised questions about how histological and histopathological methods impact the evaluation of biomarker performance. A group of pathologists was asked to analyze digitized images prepared from rodent kidney injury experiments in studies designed to investigate sources of variability in histopathology evaluations. Study A maximized variability by using samples from diverse studies and providing minimal guidance, contextual information, or opportunities for pathologist interaction. Study B was designed to limit interpathol...
Source: Toxicologic Pathology - December 17, 2014 Category: Pathology Authors: Rouse R, Min M, Francke S, Mog S, Zhang J, Shea K, Stewart S, Colatsky T Tags: Toxicol Pathol Source Type: research

Enteral Nutrition Formula Selection: Current Evidence and Implications for Practice.
Abstract Many new enteral nutrition (EN) formulas have been created over the past several decades with a variety of intended uses. Although each is intended to promote improved outcomes, research is often unclear and, in many cases, conflicting. It is important to note that EN products are considered medical foods by the U.S. Food and Drug Administration and therefore do not have to complete premarket review or approval and are not regulated to the same extent as pharmaceuticals. While standard EN formulas are designed to meet the basic macro- and micronutrient requirements of individuals who cannot meet nutrition ...
Source: Nutrition in Clinical Practice - December 16, 2014 Category: Nutrition Authors: Brown B, Roehl K, Betz M Tags: Nutr Clin Pract Source Type: research

Identification of a mast-cell-specific receptor crucial for pseudo-allergic drug reactions
Nature advance online publication 17 December 2014. doi:10.1038/nature14022 Authors: Benjamin D. McNeil, Priyanka Pundir, Sonya Meeker, Liang Han, Bradley J. Undem, Marianna Kulka & Xinzhong Dong Mast cells are primary effectors in allergic reactions, and may have important roles in disease by secreting histamine and various inflammatory and immunomodulatory substances. Although they are classically activated by immunoglobulin (Ig)E antibodies, a unique property of mast cells is their antibody-independent responsiveness to a range of cationic substances, collectively called basic secretagogues, including inflammatory ...
Source: Nature AOP - December 15, 2014 Category: Research Authors: Benjamin D. McNeilPriyanka PundirSonya MeekerLiang HanBradley J. UndemMarianna KulkaXinzhong Dong Tags: Letter Source Type: research

Drug-refractory aggression, self-injurious behavior, and severe tantrums in autism spectrum disorders: A chart review study
Aggression, self-injurious behavior, and severe tantrums are impairing symptoms frequently experienced by individuals with autism spectrum disorders. Despite US Food and Drug Administration approval of two atypical antipsychotics targeting these symptoms in youth with autistic disorder, they remain frequently drug refractory. We define drug-refractory aggression, self-injurious behavior, and severe tantrums in people with autism spectrum disorders as behavioral symptoms requiring medication adjustment despite previous trials of risperidone and aripiprazole or previous trials of three psychotropic drugs targeting the sympto...
Source: Autism - December 15, 2014 Category: Neurology Authors: Adler, B. A., Wink, L. K., Early, M., Shaffer, R., Minshawi, N., McDougle, C. J., Erickson, C. A. Tags: Short Reports Source Type: research

Faecal microbiota transplantation: from practice to legislation before considering industrialization
Abstract Recurrent Clostridium difficile infections constitute an important medical concern. Evidence has been provided showing that faecal microbiota transplantation is a more efficient treatment than antibiotics. Serious side effects are unusual, and acceptability is not an obstacle. Nevertheless, protocols are heterogeneous with respect to the selection of donors and the methodology used for the faecal transplantation. Regulations by both the Food and Drug Administration and the French authorities consider stool samples to be drugs, and suggest strict supervision in clinical trials. Donor screening by questionnaire or b...
Source: Clinical Microbiology and Infection - December 15, 2014 Category: Microbiology Authors: J.‐C. Lagier Tags: Review Source Type: research

Going viral: chimeric antigen receptor T‐cell therapy for hematological malignancies
Summary On July 1, 2014, the United States Food and Drug Administration granted ‘breakthrough therapy’ designation to CTL019, the anti‐CD19 chimeric antigen receptor T‐cell therapy developed at the University of Pennsylvania. This is the first personalized cellular therapy for cancer to be so designated and occurred 25 years after the first publication describing genetic redirection of T cells to a surface antigen of choice. The peer‐reviewed literature currently contains the outcomes of more than 100 patients treated on clinical trials of anti‐CD19 redirected T cells, and preliminary results on many more pati...
Source: Immunological Reviews - December 15, 2014 Category: Allergy & Immunology Authors: Saar Gill, Carl H. June Tags: Invited Review Source Type: research

Use of Bone Morphogenetic Protein Among Patients Undergoing Fusion for Degenerative Diagnoses in the United States, 2002-2012
Use of Bone Morphogenetic Protein (BMP) as an adjunct to spinal fusion surgery proliferated following Food and Drug Administration (FDA) approval in 2002. Major safety concerns emerged in 2008. (Source: The Spine Journal)
Source: The Spine Journal - December 15, 2014 Category: Orthopaedics Authors: Brook I. Martin, Jon D. Lurie, Anna N.A. Tosteson, Richard A. Deyo, Farrokh Farrokhi, Sohail K. Mirza Tags: Clinical studies Source Type: research

We Can See the (Risks of UV) Light
In the United States, it has been estimated that in the past year more than one-third of adults used indoor tanning facilities, exposing themselves to high-pressure sunlamp products that emit UV light and radiation. Rates exceeded 50% among university students and were nearly 20% among adolescents. Unfortunately, it has taken years for the cultural mystique of the “healthy tan” to be replaced by an informed understanding of the risks of tanning, both indoor and outdoor, including premature skin aging, eye damage, and melanoma and other skin cancers. Citing these risks in 2013, the US Food and Drug Administration reclas...
Source: JAMA Internal Medicine - December 15, 2014 Category: Internal Medicine Source Type: research

Direct Site-Specific Glycoform Identification and Quantitative Comparison of Glycoprotein Therapeutics: Imiglucerase and Velaglucerase Alfa
Abstract Gaucher disease, the most common lysosomal metabolic disorder, can be treated with enzyme replacement therapy (ERT). Recombinant human glucocerebrosidase imiglucerase (Cerezyme®), produced in Chinese hamster ovary cells, has been used for ERT of Gaucher disease for 20 years. Another recombinant glucocerebrosidase velaglucerase alfa (VPRIV), expressed in a human fibroblast cell line, was approved by the US Food and Drug Administration in 2010. The amino acid sequence difference at residue 495 of these two products is well documented. The overall N-linked qualitative glycan composition of these two product...
Source: The AAPS Journal - December 13, 2014 Category: Drugs & Pharmacology Source Type: research

[Editorial] Drug labelling and pregnancy
According to the US Food and Drug Administration (FDA), more than 6 million pregnancies occur in the USA every year, with women taking between three and five prescription drugs during pregnancy. In 1979, the FDA introduced a classification system to inform physicians and patients about the potential risks of drug use during pregnancy, ranging from A (no evidence of harm based on data from both animal and human studies) through to D (definite risk based on data from human research, but also potential benefits for use in pregnancy). (Source: LANCET)
Source: LANCET - December 12, 2014 Category: Journals (General) Authors: The Lancet Tags: Editorial Source Type: research

Biopharmaceuticals for rheumatic diseases in Latin America, Europe, Russia, and India: Innovators, biosimilars, and intended copies
Publication date: December 2014 Source:Joint Bone Spine, Volume 81, Issue 6 Author(s): Gilberto Castañeda-Hernández , Zoltan Szekanecz , Eduardo Mysler , Valderilio F. Azevedo , Renato Guzman , Miguel Gutierrez , Wilfredo Rodríguez , Dmitry Karateev A biosimilar is a biopharmaceutical product intended to be comparable to a previously licensed biopharmaceutical agent. The goal of such products is to increase the accessibility of biopharmaceutical therapy for rheumatoid arthritis by reducing costs. They are not like generic drugs, in that they may differ from the reference products in manufacturing, composition, and for...
Source: Joint Bone Spine - December 12, 2014 Category: Orthopaedics Source Type: research

Fanconi Syndrome Induced by Vemurafenib: A New Renal Adverse Event
Vemurafenib is a BRAF inhibitor approved by the US Food and Drug Administration as treatment for patients with unresectable or metastatic melanoma harboring the BRAF... » (Source: JAMA Oncology)
Source: JAMA Oncology - December 11, 2014 Category: Cancer & Oncology Authors: Daphné Denis, MD and colleagues Tags: Clinical Review & Education JAMA Dermatology Observation Source Type: research

Effect of Listeria seeligeri or Listeria welshimeri on Listeria monocytogenes detection in and recovery from buffered Listeria enrichment broth.
Abstract The presence of multiple species of Listeria in regulated food products is not uncommon and can complicate the recovery of Listeria monocytogenes particularly on a non-differentiating medium. The potential complications of Listeria seeligeri and Listeria welshimeri on the recovery of L. monocytogenes from inoculated food test samples using the U.S. Food and Drug Administration's (FDA) selective enrichment procedure was investigated. Post-enrichment enumeration, in the absence of food product, indicates that some L. seeligeri and L. monocytogenes pairings may have population differentials as great as 2.7...
Source: Food Microbiology - December 11, 2014 Category: Food Science Authors: Dailey RC, Welch LJ, Hitchins AD, Smiley RD Tags: Food Microbiol Source Type: research

BRAF and MEK Inhibition Variably Affect GD2-specific Chimeric Antigen Receptor (CAR) T-Cell Function In Vitro
We report that, although all these drugs lead to inhibition of stimulated T cells at high concentrations in vitro, only Vem inhibited T cells at concentrations equivalent to reported plasma concentrations in treated patients. Although the combination of Dab and Tram also resulted in inhibition of T-cell effector functions at some therapeutic concentrations, Dab itself had little adverse effect on CAR T-cell function. These findings may have implications for novel therapeutic combinations of adoptive CAR T-cell immunotherapy and MAPK pathway inhibitors. (Source: Journal of Immunotherapy)
Source: Journal of Immunotherapy - December 11, 2014 Category: Allergy & Immunology Tags: Basic Studies Source Type: research

Transvenous extraction profile of Riata Leads: procedural outcomes and technical complexity of mechanical removal
Riata (RT) and Sprint Fidelis (SF) leads were recalled by the Food and Drug Administration because of an increased rate of failure mainly due to conductor fracture or insulation abrasion. According to lead design and type of failure, extraction complexity may be different, potentially affecting procedural outcomes and indications. (Source: Heart Rhythm)
Source: Heart Rhythm - December 11, 2014 Category: Cardiology Authors: Maria Grazia Bongiorni, Andrea Di Cori, Luca Segreti, Giulio Zucchelli, Stefano Viani, Luca Paperini, Raffaele De Lucia, Dianora Levorato, Adriano Boem, Ezio Soldati Source Type: research

Fanconi Syndrome Induced by Vemurafenib A New Renal Adverse Event
We describe herein a patient exhibiting Fanconi syndrome as a new renal adverse event while undergoing treatment with vemurafenib. (Source: JAMA Dermatology)
Source: JAMA Dermatology - December 10, 2014 Category: Dermatology Source Type: research

Multi-Target Stool DNA Test: A New High Bar for Noninvasive Screening
Abstract Stool DNA testing has evolved into what is now a highly accurate and well-validated test for the screen detection of colorectal neoplasia. An optimized and automated multi-target stool DNA test (MT-sDNA) has achieved the same high point-sensitivities as reported for colonoscopy and significantly higher sensitivity than by fecal immunochemical blood testing for detection of early-stage cancer and advanced precancer. Thus, MT-sDNA sets a new high criterion standard for the noninvasive screen detection of colorectal neoplasia. With clinical application, MT-sDNA has potential to meaningfully address current g...
Source: Digestive Diseases and Sciences - December 9, 2014 Category: Gastroenterology Source Type: research

Hematologic Issues in the Geriatric Surgical Patient.
Abstract Geriatric patients are at higher risk for hemorrhagic complications after surgery and traumatic injuries. The geriatric population is more likely to take anticoagulant or antiplatelet medications. Chronic disease, autoimmune disease, and nutritional deficiencies can lead to coagulation factor and platelet disorders. One must be familiar with the current anticoagulant and antiplatelet medications, their mechanism of action, and reversal agents to properly care for this group of patients. The new oral anticoagulants do not have Food and Drug Administration (FDA) approved reversal agents, but known procoagula...
Source: The Surgical Clinics of North America - December 9, 2014 Category: Surgery Authors: Van PY, Schreiber MA Tags: Surg Clin North Am Source Type: research

Sources of innovation: an assessment of intellectual property.
Abstract An analysis of US Food and Drug Administration (FDA)-approved new molecular entities (NMEs) reveals dynamism in terms of new innovation. An assessment of the first patent for each drug shows that the pharmaceutical industry, particularly large, established companies in North America, tend to dominate the field. Over the past 10-15 years, European and Asian organizations have begun to close the gap. A dynamic inventive environment in drug discovery is suggested by the fact that NMEs for biologics or awarded to biotechnology companies often have inventors from the pharmaceutical and academic sectors. Whereas...
Source: Drug Discovery Today - December 9, 2014 Category: Drugs & Pharmacology Authors: Kinch MS, Raffo J Tags: Drug Discov Today Source Type: research

Food and Drug Administration Regulation of Drugs That Raise Blood Pressure
Although it is recognized that a systolic blood pressure (SBP) increase ≥2 mm Hg or a diastolic blood pressure (DBP) increase ≥1 mm Hg increases the risk of heart attacks and strokes in middle-aged adults, the Food and Drug Administration (FDA) lacks an adequate policy for regulating medications that increase blood pressure (BP). Some FDA reviewers consider a clinically significant increase in BP to occur only if a drug raises SBP ≥20 mm Hg or if a drug raises DBP ≥10 to 15 mm Hg. In recent years, numerous drugs have been regulated or taken off the market due to cardiovascular safety concerns. The list includes...
Source: Journal of Cardiovascular Pharmacology and Therapeutics - December 8, 2014 Category: Cardiology Authors: Blankfield, R. P., Iftikhar, I. H. Tags: Editorials Source Type: research

Protein Engineering: A New Frontier for Biological Therapeutics.
Abstract Protein engineering holds the potential to transform the metabolic drug landscape through the development of smart, stimulus-responsive drug systems. Protein therapeutics are a rapidly expanding segment of Food and Drug Administration approved drugs that will improve clinical outcomes over the long run. Engineering of protein therapeutics is still in its infancy, but recent general advances in protein engineering capabilities are being leveraged to yield improved control over both pharmacokinetics and pharmacodynamics. Stimulus-responsive protein therapeutics are drugs which have been designed to be metabo...
Source: Current Drug Metabolism - December 8, 2014 Category: Drugs & Pharmacology Authors: Tobin PH, Richards DH, Callender RA, Wilson CJ Tags: Curr Drug Metab Source Type: research

Assessing cognition and function in Alzheimer's disease clinical trials: Do we have the right tools?
Authors: Snyder PJ, Kahle-Wrobleski K, Brannan S, Miller DS, Schindler RJ, DeSanti S, Ryan JM, Morrison G, Grundman M, Chandler J, Caselli RJ, Isaac M, Bain L, Carrillo MC Abstract Several lines of evidence from Alzheimer's disease (AD) research continue to support the notion that the biological changes associated with AD are occurring possibly several decades before an individual will experience the cognitive and functional changes associated with the disease. The National Institute on Aging-Alzheimer's Association revised criteria for AD provided a framework for this new thinking. As a result of this growing unde...
Source: The Journal of Alzheimers Association - December 6, 2014 Category: Psychiatry Tags: Alzheimers Dement Source Type: research

Modelling microbial inactivation kinetics of combined UV-H treatments in apple juice
Publication date: Available online 5 December 2014 Source:Innovative Food Science & Emerging Technologies Author(s): M. Gouma , I. Álvarez , S. Condón , E. Gayán In this investigation, temperature’s effect on the ultraviolet (UV) inactivation kinetics of pathogens of concern in juices—E. coli, Salmonella Typhimurium, L. monocytogenes, and S. aureus—was studied to establish the target microorganism and process criteria for pasteurizing apple juice using combined shortwave UV-C light and mild heat (UV-H) treatments. For this purpose, mathematical models based on Geeraerd et al.´s model, which predict UV-H...
Source: Innovative Food Science and Emerging Technologies - December 6, 2014 Category: Food Science Source Type: research

New potential for enhancing concomitant chemoradiotherapy with FDA approved concentrations of cisplatin via the photoelectric effect
We predict, for the first time, that by using United States Food and Drug Administration approved concentrations of cisplatin, major radiosensitization may be achieved via photoelectric mechanism during concomitant chemoradiotherapy (CCRT). Our analytical calculations estimate that radiotherapy (RT) dose to cancer cells may be enhanced via this mechanism by over 100% during CCRT. The results proffer new potential for significantly enhancing CCRT via an emerging clinical scenario, where the cisplatin is released in-situ from RT biomaterials loaded with cisplatin nanoparticles. (Source: Physica Medica: European Journal of Medical Physics)
Source: Physica Medica: European Journal of Medical Physics - December 6, 2014 Category: Journals (General) Authors: Yucel Altundal, Gizem Cifter, Alexandre Detappe, Erno Sajo, Panagiotis Tsiamas, Piotr Zygmanski, Ross Berbeco, Robert A. Cormack, Mike Makrigiorgos, Wilfred Ngwa Tags: Original paper Source Type: research

Oral anticoagulation in atrial fibrillation.
Authors: Ansari JG, Garcha GS, Lakkis N Abstract Atrial fibrillation affects approximately 5 million patients in the United States. The rate of stroke in adults with atrial fibrillation depending on their risk factors varies between 1-20% annually. Anticoagulation with vitamin K antagonists such as warfarin has been the mainstay therapy but it is cumbersome and requires close follow-up. Since 2010, three new oral anticoagulants have received Food and Drug Administration approval for stroke prevention in atrial fibrillation. This review summarizes data from three landmark trials: RE-LY, ROCKET-AF, and ARISTOTLE. In ...
Source: Cardiovascular and Hematological Agents in Medicinal Chemistry - December 5, 2014 Category: Cardiology Tags: Cardiovasc Hematol Agents Med Chem Source Type: research

The need for annual echocardiography to detect cabergoline-associated valvulopathy in patients with prolactinoma: a systematic review and additional clinical data
Publication date: Available online 14 November 2014 Source:The Lancet Diabetes & Endocrinology Author(s): Carmela Caputo , David Prior , Warrick J Inder Present recommendations by the US Food and Drug Administration advise that patients with prolactinoma treated with cabergoline should have an annual echocardiogram to screen for valvular heart disease. Here, we present new clinical data and a systematic review of the scientific literature showing that the prevalence of cabergoline-associated valvulopathy is very low. We prospectively assessed 40 patients with prolactinoma taking cabergoline. Cardiovascular examin...
Source: The Lancet Diabetes and Endocrinology - December 5, 2014 Category: Endocrinology Source Type: research

Cholangioscopy-assisted photodynamic therapy for cholangiocarcinoma
A 62-year-old man with unresectable cholangiocarcinoma underwent ERCP with photodynamic therapy (PDT) under cholangioscopic guidance. Forty-eight hours before this procedure, the patient was injected with Photofrin (Pinnacle Biologics, Bannockburn, Ill), the only photosensitizer currently approved by the U.S. Food and Drug Administration (FDA). (Source: Gastrointestinal Endoscopy)
Source: Gastrointestinal Endoscopy - December 5, 2014 Category: Gastroenterology Authors: Janaki Patel, Nada Rizk, Prashant Kedia, Reem Z. Sharaiha, Michel Kahaleh Tags: VideoGIE Source Type: research

Electronic chromoendoscopy
The ASGE Technology Committee provides reviews of existing, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Evidence-based methodology is used, performing a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported adverse events of a given technology. Both are supplemented by accessing the “related articles” feature of PubMed and by scrutinizing pertinent references cited by the identified studies. (Source: Gastrointestinal Endoscopy)
Source: Gastrointestinal Endoscopy - December 5, 2014 Category: Gastroenterology Authors: ASGE Technology Committee, Michael A. Manfredi, Barham K. Abu Dayyeh, Yasser M. Bhat, Shailendra S. Chauhan, Klaus T. Gottlieb, Joo Ha Hwang, Sri Komanduri, Vani Konda, Simon K. Lo, John T. Maple, Faris M. Murad, Uzma D. Siddiqui, Michael B. Wallace, Subh Tags: Status evaluation report Source Type: research

Should development of Alzheimer¿s disease-specific intravenous immunoglobulin be considered?
Recent phase II and III studies with intravenous immunoglobulin (IVIG) in patients with Alzheimer?s disease (AD) did not find evidence for the slowing of AD progression compared to placebo-treated patients, in contrast to encouraging results in pilot studies. An additional phase III trial is ongoing. If negative results are found, then further AD studies with IVIG are unlikely unless a manufacturer opts for a trial with high-dose IVIG, which would increase its anti-inflammatory effects but also the risk for adverse events. An alternative approach could be an AD-specific IVIG, supplementing IVIG with higher concentrations o...
Source: Journal of Neuroinflammation - December 5, 2014 Category: Neurology Authors: David Loeffler Source Type: research

Should development of Alzheimer¿s disease-specific intravenous immunoglobulin be considered?
Recent phase II and III studies with intravenous immunoglobulin (IVIG) in patients with Alzheimer’s disease (AD) did not find evidence for the slowing of AD progression compared to placebo-treated patients, in contrast to encouraging results in pilot studies. An additional phase III trial is ongoing. If negative results are found, then further AD studies with IVIG are unlikely unless a manufacturer opts for a trial with high-dose IVIG, which would increase its anti-inflammatory effects but also the risk for adverse events. An alternative approach could be an AD-specific IVIG, supplementing IVIG with higher concentrations...
Source: Journal of Neuroinflammation - December 5, 2014 Category: Neurology Authors: David Loeffler Source Type: research

Awareness of Human Papillomavirus Vaccine Among Adolescent African American Males Who Have Sex with Males: a Pilot Study
This study demonstrates the need for the development of health communication intervention and more research targeting African American MSMs and also the need for policy change towards making the HPV vaccine routine for males especially adolescents at no cost. (Source: Journal of Racial and Ethnic Health Disparities)
Source: Journal of Racial and Ethnic Health Disparities - December 4, 2014 Category: Global & Universal Source Type: research

A new model of in vitro fungal biofilms formed on human nail fragments allows reliable testing of laser and light therapies against onychomycosis
Abstract Onychomycoses represent approximately 50 % of all nail diseases worldwide. In warmer and more humid countries like Brazil, the incidence of onychomycoses caused by non-dermatophyte molds (NDM, including Fusarium spp.) or yeasts (including Candida albicans) has been increasing. Traditional antifungal treatments used for the dermatophyte-borne disease are less effective against onychomycoses caused by NDM. Although some laser and light treatments have demonstrated clinical efficacy against onychomycosis, their US Food and Drug Administration (FDA) approval as “first-line” therapy is pending, partly due...
Source: Lasers in Medical Science - December 4, 2014 Category: Laser Surgery Source Type: research

Proceedings From FDA/A.S.P.E.N. Public Workshop: Clinical Trial Design for Intravenous Fat Emulsion Products, October 29, 2013.
Abstract The development of intravenous fat emulsion (IVFE) is the culmination of physiological, biochemical, nutritional, and medical scientific advancements. IVFEs have the ability to deliver critical nutritional substrates to the patient. Recent literature purports that they may also play roles in modulation of immune functionality and pulmonary physiology, but data supporting these potential benefits are limited. While soybean-based IVFEs have comprised the dominant fat in U.S. markets, a number of other novel IVFEs may prove to optimize the care of children and adults in both hospitalized and home settings. Th...
Source: JPEN Journal Of Parenteral And Enteral Nutrition - December 4, 2014 Category: Nutrition Authors: Teitelbaum DH, Guenter P, Griebel D, Abrams SA, Bark S, Baker M, Berry KL, Bistrian BR, Brenna JT, Bonnot D, Carpentier YA, Deckelbaum RJ, Hise M, Koletzko B, Mirtallo JM, Mulberg AE, O'Reilly RC, Shaffer J, von Kleist E, Zaloga GP, Ziegler TR Tags: JPEN J Parenter Enteral Nutr Source Type: research

Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling. Final rule.
Abstract The Food and Drug Administration (FDA) is amending its regulations governing the content and format of the "Pregnancy," "Labor and delivery," and "Nursing mothers" subsections of the "Use in Specific Populations" section of the labeling for human prescription drug and biological products. The final rule requires the removal of the pregnancy categories A, B, C, D, and X from all human prescription drug and biological product labeling. For human prescription drug and biological products subject to the Agency's 2006 Physician Labeling Rule, the final rule requires that the labeling include a summary of the ri...
Source: Fed Regist - December 4, 2014 Category: American Health Authors: Food and Drug Administration, HHS Tags: Fed Regist Source Type: research

BRAF Inhibitors: Experience in Thyroid Cancer and General Review of Toxicity
Abstract The US Food and Drug Administration-approved BRAF inhibitors, vemurafenib and dabrafenib, have demonstrated superior efficacy in patients with BRAF-mutant melanomas but have limited efficacy in BRAF-mutant colorectal cancer. Little is known at this time regarding BRAF inhibitors in thyroid cancer. Initial reports in patients with progressive, radioactive iodine–refractory BRAF-mutant papillary thyroid cancer suggest response rates of approximately 30–40 %. In this review, we discuss BRAF inhibitors in the context of thyroid cancer, the toxicities associated with BRAF inhibitors, and the suggested man...
Source: Hormones and Cancer - December 3, 2014 Category: Cancer & Oncology Source Type: research

Evaluation of Subcutaneous Phenobarbital Administration in Hospice Patients.
This study evaluates the tolerability of phenobarbital administered subcutaneously. Of 69 patients and 774 distinct subcutaneous phenobarbital injections, 2 site reactions were recorded (2.9% of patients; 0.3% of injections). Both were mild, grade 1 reactions. Each patient continued to receive subcutaneous phenobarbital via newly placed ports with no additional reactions. Based on these findings, phenobarbital appears to be well tolerated when administered subcutaneously. PMID: 25473092 [PubMed - as supplied by publisher] (Source: The American Journal of Hospice and Palliative Care)
Source: The American Journal of Hospice and Palliative Care - December 3, 2014 Category: Palliative Care Authors: Hosgood JR, Kimbrel JM, Protus BM, Grauer PA Tags: Am J Hosp Palliat Care Source Type: research

Radionuclide Therapy for Osseous Metastases in Prostate Cancer
Bone metastases are associated with increased morbidity and poor prognosis in castration-resistant prostate cancer. Since 2010, 5 systemic therapies for metastatic castration-resistant prostate cancer have been approved by the US Food and Drug Administration based on an improvement in overall survival, offering alternatives to docetaxel, a chemotherapeutic agent with modest effect and significant toxicity. These systemic treatments belong to different classes of medication such as immunotherapy, hormonal therapy, chemotherapy, and radionuclide therapy. (Source: Seminars in Nuclear Medicine)
Source: Seminars in Nuclear Medicine - December 2, 2014 Category: Radiology Authors: Alain S. Abi-Ghanem, Mary A. McGrath, Heather A. Jacene Source Type: research

Determination of bioequivalence for drugs with narrow therapeutic index: reduction of the regulatory burden.
Authors: Endrenyi L, Tothfalusi L Abstract The US Food and Drug Administration (FDA) has recently suggested that the bioequivalence (BE) for products of drugs with narrow therapeutic indices (NTI) be assessed by the approach of reference-scaled average BE (SABE). Subsequently, in December, 2012, the FDA issued draft guidances for the comparison of products of warfarin sodium and of tacrolimus. The guidances expect that 4-period studies be performed, that the results be evaluated by SABE, and that the analysis include also unscaled average BE as well as the comparison of the estimated within-subject variations (sW) ...
Source: Journal of Pharmacy and Pharmaceutical Sciences - December 2, 2014 Category: Drugs & Pharmacology Tags: J Pharm Pharm Sci Source Type: research

Buprenorphine in the workers' compensation setting.
This article reviews buprenorphine's approved indications, formulations, pharmacology, clinical efficacy, and special considerations in the workers' compensation setting. PMID: 25162607 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - December 2, 2014 Category: Addiction Tags: J Opioid Manag Source Type: research

Clinical applications of oxymorphone.
Authors: Vadivelu N, Maria M, Jolly S, Rosenbloom J, Prasad A, Kaye AD Abstract Oxymorphone (14-hydroxydihydromorphinone), a pyridine ring unsubstituted pyridomorphinan, a semisynthetic opioid analgesic derived from thebaine, first developed in the year 1914 and has been available as oxymorphone hydrochloride parenteral forms in the United States since 1959, when the US Food and Drug Administration approved it. Over the years, it has been used for the alleviation of moderate-to-severe pain. Pharmacological considerations, new and traditional formulations, clinical indications, and recent study populations are exami...
Source: Journal of Opioid Management - December 2, 2014 Category: Addiction Tags: J Opioid Manag Source Type: research

ADHD medication use following FDA risk warnings.
We examined whether children (ages 0 to 20) filled a prescription for any ADHD medication during the calendar year. Next, we used content analysis methods to analyze news coverage of the issue in 10 high-circulation newspapers, the 3 major television networks and a major cable news network in the U.S. We examined 6 measures capturing information conveyed on risk and benefits of ADHD medication use. RESULTS: No declines in medication use following FDA safety warnings overall or by parental education level were observed. News media coverage was relatively balanced in its portrayal of the risks and benefits of ADHD medica...
Source: Journal of Mental Health Policy and Economics - December 2, 2014 Category: Psychiatry Tags: J Ment Health Policy Econ Source Type: research