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Cough and cold medications: Why don't they go away?
At some level, most of us realize that the bulk of “cough and cold medications” don't really work and may be harmful to children. About six years ago, the US Food and Drug Administration and the pharmaceutical industry undertook some initiatives to limit the use of such preparations in young children, those most vulnerable to adverse effects. (Source: The Journal of Pediatrics)
Source: The Journal of Pediatrics - October 28, 2014 Category: Pediatrics Authors: Thomas R. Welch Tags: The Editors' Perspectives Source Type: research

Effect of Food and Drug Administration Decisions on Sexual Medicine Research
(Source: The Journal of Sexual Medicine)
Source: The Journal of Sexual Medicine - October 28, 2014 Category: Sexual Medicine Authors: Irwin Goldstein Tags: EDITORIAL Source Type: research

Optimal size of anticancer nanomedicine [Engineering]
Nanomedicines (NMs) offer new solutions for cancer diagnosis and therapy. However, extension of progression-free interval and overall survival time achieved by Food and Drug Administration-approved NMs remain modest. To develop next generation NMs to achieve superior anticancer activities, it is crucial to investigate and understand the correlation between the physicochemical... (Source: Proceedings of the National Academy of Sciences)
Source: Proceedings of the National Academy of Sciences - October 28, 2014 Category: Science Authors: Tang, L., Yang, X., Yin, Q., Cai, K., Wang, H., Chaudhury, I., Yao, C., Zhou, Q., Kwon, M., Hartman, J. A., Dobrucki, I. T., Dobrucki, L. W., Borst, L. B., Lezmi, S., Helferich, W. G., Ferguson, A. L., Fan, T. M., Cheng, J. Tags: Physical Sciences Source Type: research

Rate of asthma trial outcomes reporting on ClinicalTrials.gov and in the published literature
To improve the transparency and reporting of clinical trials, the US Congress passed the Food and Drug Administration Amendments Act (FDAAA) of 2007, which requires investigators to upload their results of investigational phase 2 to 4 drug, biologic, and device trials within 1 year of the trial's completion.1 Noncompliance can result in the withholding of National Institutes of Health grant funding and civil monetary penalties of up to $10,000.2 However, a recent report found that only 22% of qualifying studies had uploaded results within the required timeframe. (Source: Journal of Allergy and Clinical Immunology)
Source: Journal of Allergy and Clinical Immunology - October 28, 2014 Category: Allergy & Immunology Authors: Chris Stockmann, Joseph S. Ross, Catherine M.T. Sherwin, Christopher A. Reilly, Brittany McDowell, Bernhard Fassl, Flory Nkoy, Christopher G. Maloney, Michael G. Spigarelli Tags: Letter to the Editor Source Type: research

Pulmonary, allergy, rheumatology drugs among 500 products with new pediatric information [FDA UPDATE]
(Source: AAP News)
Source: AAP News - October 27, 2014 Category: Pediatrics Authors: Food and Drug Administration Office of Pediatric Therapeutics, Pediatric & Maternal Health Staff, Division of Pulmonary, Allergy and Rheumatology Products Tags: FDA Update, Pulmonology Source Type: research

FDA Perspective on Sofosbuvir Therapy for Patients With Chronic Hepatitis C Virus Genotype 1 Infection Who Did Not Respond to Treatment With Pegylated Interferon and Ribavirin
On December 6, 2013, the U.S. Food and Drug Administration (FDA) approved sofosbuvir (SOF) for the treatment of chronic hepatitis C (CHC) viral infection as a component of an antiviral treatment regimen. SOF is an inhibitor of the hepatitis C virus (HCV) NS5B RNA-dependent RNA polymerase and inhibits HCV replication. SOF was designated a breakthrough therapy because preliminary clinical evidence indicated substantial improvement over available therapies for the treatment of CHC infection.1 It was the first drug with a breakthrough therapy designation approved for treatment of CHC. (Source: Gastroenterology)
Source: Gastroenterology - October 27, 2014 Category: Gastroenterology Authors: Poonam Mishra, Jeffry Florian, Karen Qi, Wen Zeng, Lisa K. Naeger, Eric Donaldson, Sarah Connelly, Jules O’Rear, Dionne Price, Jeffrey Murray, Debra Birnkrant Tags: Commentary Source Type: research

Evaluation of sunscreens distributed by 2 major US retailers for meeting recommendations by the American Academy of Dermatology
To the Editor: In 2011, the Food and Drug Administration (FDA) released its final rule to standardize labeling and effectiveness testing for sunscreens.1,2 Under this rule, sunscreens that pass a standardized in vitro test for ultraviolet A protection may claim to be broad spectrum, and must use a standardized labeling format where the “broad spectrum” and sun-protection factor (“SPF”) label appear immediately next to each other in the same font style, size, and color. The final rule also simplifies water resistance claims to “water resistant (40 minutes)” or “water resistant (80 minutes).” The American Ac...
Source: Journal of the American Academy of Dermatology - October 26, 2014 Category: Dermatology Authors: Mohammad-Ali Yazdani Abyaneh, Robert D. Griffith, Leyre Falto-Aizpurua, Keyvan Nouri Tags: Letter Source Type: research

Addressing the FDA
On July 24, 2014, I had the opportunity to address the Food and Drug Administration (FDA) about adding phosphorus to the nutrition facts label. My statement is included in this edition of the Journal. (Source: Journal of Renal Nutrition)
Source: Journal of Renal Nutrition - October 26, 2014 Category: Urology & Nephrology Authors: Lisa Gutekunst Tags: Message From the Chairperson Source Type: research

The National Kidney Foundation Council on Renal Nutrition Addresses the Food and Drug Administration
On July 24, 2014, the Food and Drug Administration (FDA) held an open forum to review proposed changes to the Nutrition Facts Label and to allow for public comment on these changes. Lisa Gutekunst, MSEd, RD, CSR, CDN, Chair of the National Kidney Foundation Council on Renal Nutrition, lobbied the FDA to add phosphorus to the Nutrition Facts Label. This is her address to the FDA. (Source: Journal of Renal Nutrition)
Source: Journal of Renal Nutrition - October 26, 2014 Category: Urology & Nephrology Authors: Lisa Gutekunst Tags: Special Report Source Type: research

Cough and cold medications: Why don't they go away?
At some level, most of us realize that the bulk of “cough and cold medications” don't really work and may be harmful to children. About six years ago, the US Food and Drug Administration and the pharmaceutical industry undertook some initiatives to limit the use of such preparations in young children, those most vulnerable to adverse effects. (Source: The Journal of Pediatrics)
Source: The Journal of Pediatrics - October 25, 2014 Category: Pediatrics Authors: Thomas R. Welch Tags: The Editors' Perspectives Source Type: research

Overview of the 2014 Food and Drug Administration Circulatory System Devices Panel Meeting Regarding the Lutonix® Drug Coated Balloon
The Lutonix® drug coated balloon (DCB) is a combination device composed of a standard percutaneous angioplasty balloon coated with paclitaxel. Depending on the balloon size, a dose density of 2μg/mm2 yields a variable total dose raging from 1.5mg to 3.8mg. This drug coated balloon aims to provide improved patency rates in patients with symptomatic femoropopliteal de novo or restenotic atherosclerotic disease.On June 12, 2014, the Food and Drug Administration's (FDA) Circulatory System Devices Panel reviewed the Lutonix DCB premarket approval application (PMA). (Source: Cardiovascular Revascularization Medicine)
Source: Cardiovascular Revascularization Medicine - October 25, 2014 Category: Cardiology Authors: Ricardo O. Escárcega, Ron Waksman Source Type: research

Comparative analysis of anatomic and reverse total shoulder arthroplasty: in-hospital outcomes and costs
The rate of shoulder arthroplasty has continued to increase at an exponential rate during the past decade in large part owing to approval by the Food and Drug Administration of reverse shoulder arthroplasty. Whereas reverse shoulder arthroplasty has resulted in expanded surgical indications, there are numerous reports of relatively high complication rates. The increased prevalence of both anatomic and reverse shoulder arthroplasty underscores the need to elucidate whether perioperative outcomes are influenced by type of total shoulder arthroplasty. (Source: Journal of Shoulder and Elbow Surgery)
Source: Journal of Shoulder and Elbow Surgery - October 25, 2014 Category: Orthopaedics Authors: Brent A. Ponce, Lasun O. Oladeji, Mark E. Rogers, Mariano E. Menendez Source Type: research

Sublingual immunotherapy in children: the recent experiences
Purpose of reviewSublingual immunotherapy (SLIT) is indicated for the use in pediatric patients suffering from allergic rhinitis or allergic rhinoconjunctivitis caused by environmental allergens, such as ragweed pollen, grass pollen, and dust mite. This review focuses on recent and relevant studies associated with the use of SLIT for these allergens in children by examining efficacy, safety, and immunological data in comparison to subcutaneous immunotherapy, therapeutic treatments, and placebo. Recent findingsIn several of the case studies examined in this article, involving mainly grass and dust mite allergic patients, SL...
Source: Current Opinion in Allergy and Clinical Immunology - October 24, 2014 Category: Allergy & Immunology Tags: IMMUNOTHERAPY AND NEW TREATMENTS: Edited by Giovanni Passalacqua and Robert Bush Source Type: research

Custom-made versus off-the-shelf multibranched endografts for endovascular repair of thoracoabdominal aortic aneurysms
In April 2012, the Food and Drug Administration approved a fenestrated endoprosthesis to treat the visceral aorta. Therefore, the existing Category III CPT codes that were used for fenestrated endovascular repair (FEVAR) of the visceral aorta were replaced with Category I CPT codes in the 2014 manual. One set of codes were created for treatment of the visceral aorta alone and a parallel set was created to report concomitant repair of the visceral aorta and the infrarenal aorta. Simultaneous to this, the four Category III CPT codes were deleted. (Source: Journal of Vascular Surgery)
Source: Journal of Vascular Surgery - October 24, 2014 Category: Surgery Authors: Sean P. Roddy Tags: CPT advisor Source Type: research

Tumor Necrosis Factor-Alpha Antagonists Twenty Years Later: What Do Cochrane Reviews Tell Us?
This article reviews the data from that session. (Source: Inflammatory Bowel Diseases)
Source: Inflammatory Bowel Diseases - October 24, 2014 Category: Gastroenterology Tags: Cochrane Review Source Type: research

Regenerative therapy for hypoplastic left heart syndrome: First report of intraoperative intramyocardial injection of autologous umbilical cord blood-derived cells
Success of surgical palliation in hypoplastic left heart syndrome (HLHS) mandates new treatment strategies to optimize long-term outcomes. In accordance with a Food and Drug Administration (FDA) monitored protocol for autologous cell-based therapy in children, umbilical cord blood was harvested from a newborn with HLHS. The blood was processed according to GMP-standards to achieve high purity mononuclear cells and then cryopreserved for scheduled cell delivery. Stage I Norwood procedure consisting of aortic arch reconstruction, atrial septectomy and right ventricle to pulmonary artery shunt was performed at 4 days of age, ...
Source: The Journal of Thoracic and Cardiovascular Surgery - October 24, 2014 Category: Cardiovascular & Thoracic Surgery Authors: Harold M. Burkhart, Muhammad Yasir Qureshi, Susana Cantero Peral, Patrick W. O’Leary, Timothy M. Olson, Frank Cetta, Timothy J. Nelson, Wanek Program Clinical Pipeline Group Source Type: research

Putrescine production via the agmatine deiminase pathway increases the growth of Lactococcus lactis and causes the alkalinization of the culture medium.
Abstract Lactococcus lactis is the most important starter culture organism used in the dairy industry. Although L. lactis species have been awarded Qualified Presumption of Safety status by the European Food Safety Authority, and Generally Regarded as Safe status by the US Food and Drug Administration, some strains can produce the biogenic amine putrescine. One such strain is L. lactis subsp. cremoris CECT 8666 (formerly L. lactis subsp. cremoris GE2-14), which was isolated from Genestoso cheese. This strain catabolizes agmatine to putrescine via the agmatine deiminase (AGDI) pathway, which involves the production ...
Source: Applied Microbiology and Biotechnology - October 24, 2014 Category: Microbiology Authors: Del Rio B, Linares DM, Ladero V, Redruello B, Fernández M, Martin MC, Alvarez MA Tags: Appl Microbiol Biotechnol Source Type: research

Vismodegib: A Review
Publication date: October 2014 Source:Actas Dermo-Sifiliográficas (English Edition), Volume 105, Issue 8 Author(s): V. Ruiz-Salas , M. Alegre , A. López-Ferrer , J.R. Garcés In January 2012, vismodegib (Erivedge, manufactured by Genentech) became the first selective inhibitor of the Hedgehog signaling pathway to be approved by the US Food and Drug Administration for the treatment of locally advanced and metastatic basal cell carcinoma. The drug selectively binds to Smoothened, a 7-helix transmembrane receptor, thereby inhibiting activation of transcription factors of the glioma-associated oncogene family and suppressi...
Source: Actas Dermo-Sifiliograficas - October 23, 2014 Category: Dermatology Source Type: research

New Therapies for Primary Biliary Cirrhosis
Abstract Primary biliary cirrhosis (PBC) is a rare inflammatory liver disease for which ursodeoxycholic acid (UDCA) is the only therapy approved by the U.S. Food and Drug Administration. Patients with a biochemical response to UDCA therapy have a similar survival rate compared to the general population. However, up to 40 % of PBC patients do not achieve a complete response to UDCA, have an increased risk of liver-related death and liver transplantation, and represent a persistent medical need for new therapies. Several novel drugs have recently been studied and show potential efficacy in PBC. Obeticholic acid, a ...
Source: Clinical Reviews in Allergy and Immunology - October 21, 2014 Category: Allergy & Immunology Source Type: research

How do we treat life-threatening anemia in a Jehovah's Witness patient?
We describe a protocol-based algorithm to the management of life-threatening anemia in JW patients and review time to anemia reversal and patient outcomes using this approach. PMID: 25330835 [PubMed - as supplied by publisher] (Source: Transfusion)
Source: Transfusion - October 21, 2014 Category: Hematology Authors: Posluszny JA, Napolitano LM Tags: Transfusion Source Type: research

Biomarkers for MS: Unpuzzling the progressive multiple sclerosis puzzle
The past 20 years have seen dramatic advances in our understanding and treatment of multiple sclerosis (MS). Diagnostic criteria have been refined, imaging has been applied to both MS diagnosis and longitudinal assessment, and 10 treatments have received US Food and Drug Administration approval, with more on the way. Neurologists can now make an MS diagnosis quickly and accurately. They can apply effective treatments to curtail inflammation, precisely monitor for continued inflammatory disease activity, and change treatments if active disease persists. Treatment paradigms now target no evident disease activity, also called...
Source: Neurology - October 20, 2014 Category: Neurology Authors: Fox, R. J. Tags: All Demyelinating disease (CNS), Multiple sclerosis EDITORIALS Source Type: research

Rechanneling the cardiac proarrhythmia safety paradigm: A meeting report from the Cardiac Safety Research Consortium
Publication date: March 2014 Source:American Heart Journal, Volume 167, Issue 3 Author(s): Philip T. Sager , Gary Gintant , J. Rick Turner , Syril Pettit , Norman Stockbridge This white paper provides a summary of a scientific proposal presented at a Cardiac Safety Research Consortium/Health and Environmental Sciences Institute/Food and Drug Administration–sponsored Think Tank, held at Food and Drug Administration's White Oak facilities, Silver Spring, MD, on July 23, 2013, with the intention of moving toward consensus on defining a new paradigm in the field of cardiac safety in which proarrhythmic risk would be primar...
Source: American Heart Journal - October 20, 2014 Category: Cardiology Source Type: research

Impact of Levonorgestrel Intrauterine Device on Endometrial Ablation Utilization for Treatment of Menorrhagia
To determine changes in endometrial ablation utilization following Food and Drug Administration (FDA) approval of the levonorgestrel intrauterine device (IUD) for treatment of menorrhagia. (Source: The Journal of Minimally Invasive Gynecology)
Source: The Journal of Minimally Invasive Gynecology - October 19, 2014 Category: OBGYN Authors: M.N. Wasson, H.T.H. Yuen, M.K. Hoffman Source Type: research

A New Application for Barbed Suture: Repair of Cystotomy and Enterotomy
Barbed suture has been approved by the Food and Drug Administration (FDA) since 2004. Here, we show examples where a unidirectional barbed suture was used for closure of intentional cystotomy and enterotomy after resection of endometriotic nodules. (Source: The Journal of Minimally Invasive Gynecology)
Source: The Journal of Minimally Invasive Gynecology - October 19, 2014 Category: OBGYN Authors: A.M. Ecker, T.T.M. Lee Source Type: research

Ezetimibe use remains common amongst medical inpatients
The US Food and Drug Administration licensed Ezetimibe in 2002 due to its ability to lower LDL-cholesterol levels, a surrogate marker for the risk of coronary artery disease. The negative results of the Effect of Ezetimibe Plus Simvastatin Versus Simvastatin Alone on Atherosclerosis in the Carotid Artery (ENHANCE) trial were published in 2008. Since then we have seen six additional years without a landmark study in favor of ezetimibe. Furthermore, the new American Heart Association/American College of Cardiology (AHA/ACC) guidelines (2013) now strongly downplay the use of non-statin agents. (Source: The American Journal of Medicine)
Source: The American Journal of Medicine - October 19, 2014 Category: Journals (General) Authors: Emily G. McDonald, Ramy R. Saleh, Todd C. Lee Source Type: research

[Perspectives] Robotic surgery: where are we now?
Robotic surgery has fascinated surgeons since its inception almost 30 years ago. US Food and Drug Administration (FDA) approval of the Da Vinci surgical system in 2000 led to the expansion of robotic-assisted laparoscopic surgery—most rapidly in urology but also in gynaecology, cardiothoracics, head and neck, and general surgery. But has this innovation in surgery translated to benefits for patients? (Source: LANCET)
Source: LANCET - October 18, 2014 Category: Journals (General) Authors: Naomi Lee Tags: Perspectives Source Type: research

Prothrombin Complex Concentrate (4PCC): A Review of its Use in Reversal of Vitamin K Antagonists
Abstract Bleeding continues to be a major adverse drug event associated with warfarin anticoagulation. The cornerstone of warfarin-related bleeding management involves repletion of affected plasma coagulation factor levels. Prothrombin complex concentrate (human) is a 4-factor prothrombin complex concentrate that contains vitamin K-dependent coagulation factors II, VII, IX, and X and anticoagulant proteins C and S. It recently received Food and Drug Administration approval for warfarin reversal for patients with major bleeding or requiring urgent surgery or other invasive procedures. Its role in reversing target-s...
Source: Current Emergency and Hospital Medicine Reports - October 18, 2014 Category: Emergency Medicine Source Type: research

Expanding Public-Private Collaborations to Enhance Cancer Drug Development: A Report of the Institute of Medicine's Workshop Series, "Implementing a National Cancer Clinical Trials System for the 21st Century"
This report identified a need to reinvigorate the cooperative groups and provided recommendations for improving their effectiveness. Follow-up workshops to monitor progress were conducted by the IOM's National Cancer Policy Forum and the American Society of Clinical Oncology (ASCO) in 2011 and 2013. One of the key recommendations of the IOM report was a call for greater collaboration among stakeholders in cancer research. In particular, more active engagement and better alignment of incentives among the cooperative groups, the National Cancer Institute, the U.S. Food and Drug Administration, and the biopharmaceutical indus...
Source: The Oncologist - October 17, 2014 Category: Cancer & Oncology Authors: Bertagnolli MM, Canetta R, Nass SJ Tags: Oncologist Source Type: research

Reduced Precision of the Pentacam HR in Eyes with Mild to Moderate Keratoconus
Corneal-collagen crosslinking (CXL) is on the verge of achieving US Food and Drug Administration approval for treatment of progressive keratoconus (KCN)1,2; therefore, being able to accurately assess progression and the effect of CXL is a fundamental requirement for clinical management.3 Currently, the corneal tomography images from the Pentacam HR device (Oculus; Weltzar, Germany) are heavily relied on in the evaluation of KCN progression. Estimates of parameters such as corneal curvature and corneal thickness are analyzed serially over time to assess change. (Source: Ophthalmology)
Source: Ophthalmology - October 16, 2014 Category: Opthalmology Authors: Kattayoon Hashemi, Ivo Guber, Ciara Bergin, François Majo Tags: Reports Source Type: research

Chronic ivacaftor treatment: Getting F508del-CFTR into more trouble?
The discovery and rapid translation of the CFTR potentiator ivacaftor (VX-770) from an in vitro investigational compound to the first approved mutation-specific drug therapy tackling the root cause of CF is an unprecedented success for the CF community [1–4]. It argues persuasively that pharmacological correction of CFTR mutants may be feasible on a broader scale, giving hope that mutation-specific drug therapies may possibly become available to all patients with CF. Currently, ivacaftor is approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for G551D-CFTR and eight other mutatio...
Source: Journal of Cystic Fibrosis - October 16, 2014 Category: Respiratory Medicine Authors: Marcus A. Mall, David N. Sheppard Tags: Editorial Source Type: research

Confocal laser endomicroscopy
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 - October 16, 2014 Category: Gastroenterology Authors: ASGE Technology Committee, Shailendra S. Chauhan, Barham K. Abu Dayyeh, Yasser M. Bhat, Klaus T. Gottlieb, Joo Ha Hwang, Sri Komanduri, Vani Konda, Simon K. Lo, Michael A. Manfredi, John T. Maple, Faris M. Murad, Uzma D. Siddiqui, Subhas Banerjee, Michael Tags: Technology status evaluation report Source Type: research

High-definition and high-magnification endoscopes
The American Society for Gastrointestinal Endoscopy (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, with 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 complications of a given technology. Both are supplemented by accessing the “related articles” feature of PubMed and by scrutinizing pertinent references cited by the id...
Source: Gastrointestinal Endoscopy - October 16, 2014 Category: Gastroenterology Authors: ASGE Technology Committee, Yasser M. Bhat, Barham K. Abu Dayyeh, Shailendra S. Chauhan, Klaus T. Gottlieb, Joo Ha Hwang, Sri Komanduri, Vani Konda, Simon K. Lo, Michael A. Manfredi, John T. Maple, Faris M. Murad, Uzma D. Siddiqui, Subhas Banerjee, Michael Tags: Technology status evaluation report Source Type: research

CDC's Tom Frieden to face Congress as two representatives call for his resignation
CDC head Dr. Thomas Frieden is expected to appear before a committee of the House of Representatives Oct. 16, as two congressmen are calling for his resignation. A subcommittee of the Energy & Commerce Committee of the House of Representatives is scheduled to hold a hearing Thursday at noon to examine the U.S. public health response to the Ebola outbreak. Frieden and officials from the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) will be among the hearing witnesses. “Ebola… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - October 15, 2014 Category: Biotechnology Authors: David Allison Source Type: research

CDC's Tom Frieden to face Congress as two representatives call for his resignation
CDC head Dr. Thomas Frieden is expected to appear before a committee of the House of Representatives Oct. 16, as two congressmen are calling for his resignation. A subcommittee of the Energy & Commerce Committee of the House of Representatives is scheduled to hold a hearing Thursday at noon to examine the U.S. public health response to the Ebola outbreak. Frieden and officials from the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) will be among the hearing witnesses. “Ebola… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - October 15, 2014 Category: Hospital Management Authors: David Allison Source Type: research

Drug delivery to the ischemic brain.
Abstract Cerebral ischemia occurs when blood flow to the brain is insufficient to meet metabolic demand. This can result from cerebral artery occlusion that interrupts blood flow, limits CNS supply of oxygen and glucose, and causes an infarction/ischemic stroke. Ischemia initiates a cascade of molecular events in neurons and cerebrovascular endothelial cells including energy depletion, dissipation of ion gradients, calcium overload, excitotoxicity, oxidative stress, and accumulation of ions and fluid. Blood-brain barrier (BBB) disruption is associated with cerebral ischemia and leads to vasogenic edema, a primary c...
Source: Advances in Pharmacology - October 15, 2014 Category: Drugs & Pharmacology Authors: Thompson BJ, Ronaldson PT Tags: Adv Pharmacol Source Type: research

iTraumaCare reaches another regulatory milestone
Canadian early-stage medical device company iTraumaCare, which has its global commercialization headquarters in San Antonio, has cleared another important regulatory hurdle for its initial product, the iTClamp Hemorrhage Control System. The U.S. Food and Drug Administration has expanded the indications for the iTClamp to include the temporary control of severe bleeding of the neck. Previously, the product’s indications for use in the U.S. included the extremities (arms and legs), axilla (arm pit),… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - October 15, 2014 Category: Pharmaceuticals Authors: W. Scott Bailey Source Type: research

Migraine Headache Prophylaxis in Adolescents
Abstract Migraine headache is estimated to affect up to 28 percent of adolescents, most of whom are female. Chronic migraine in this population has been associated with reduced quality of life and academic disruption due to missed school days. Historically, migraine headache was treated episodically as it occurred. In March 2014 the U.S. Food and Drug Administration approved an existing medication, topiramate (Topamax®), for migraine prophylaxis in adolescents between the ages of 12 and 17. This is the first FDA approval of a drug for migraine prevention in this population. There are several possible adverse effects of ta...
Source: AWHONN Lifelines - October 14, 2014 Category: Nursing Authors: Heidi Collins Fantasia Tags: Rx Source Type: research

Exploring ethical conflicts in emergency trauma research: The COMBAT (Control of Major Bleeding after Trauma) study experience
We describe the community consultation and public disclosure (CC/PD) process in preparation for an ER-EIC study, namely the Control Of Major Bleeding After Trauma (COMBAT) study. (Source: Surgery)
Source: Surgery - October 14, 2014 Category: Surgery Authors: Theresa L. Chin, Ernest E. Moore, Marilyn E. Coors, James G. Chandler, Arsen Ghasabyan, Jeffrey N. Harr, John R. Stringham, Christopher R. Ramos, Sarah Ammons, Anirban Banerjee, Angela Sauaia Tags: Original Communication Source Type: research

The Targeting of Indoleamine 2,3 Dioxygenase ‐Mediated Immune Escape in Cancer
Abstract The era of immunotherapies was unleashed in 2010 with the Food and Drug Administration (FDA) approval of the first therapeutic vaccine sipuleucel‐T as a standard treatment for metastatic prostate cancer. Next, the first immune‐activating anticytotoxic lymphocyte antigen‐4 (CTLA‐4) antibody ipilimumab exhibiting ‘immune checkpoint blockade’ was approved by FDA and European Medical Agency (EMA) for the treatment of patients with metastatic melanoma. New generations of immune checkpoint blockading antibodies targeting programmed cell death 1 (PD‐1) and its ligand (PD‐L1) are now under intense investig...
Source: Basic and Clinical Pharmacology and Toxicology - October 13, 2014 Category: Drugs & Pharmacology Authors: Trine Zeeberg Iversen, Mads Hald Andersen, Inge Marie Svane Tags: MiniReview Source Type: research

Azithromycin and congenital heart disease
In March 2013, the US Food and Drug Administration (FDA) issued a Drug Safety Communication warning related to azithromycin and the potential of causing abnormal changes in cardiac electrical activity which may lead to lethal cardiac arrhythmias. The risk of torsades de pointes and fatal arrhythmia could develop during treatment with azithromycin in a certain group of patients at higher risk. These higher risk patients include those with a prolonged QT interval, history of torsades de pointes, congenital long QT syndrome, and bradyarrhythmias. (Source: International Journal of Oral and Maxillofacial Surgery)
Source: International Journal of Oral and Maxillofacial Surgery - October 13, 2014 Category: ENT & OMF Authors: F.B. Rihani Tags: Letter to the Editor Source Type: research

POMALIDOMID – nowy immunomodulujący lek w terapii szpiczaka plazmocytowego
Publication date: April–June 2014 Source:Acta Haematologica Polonica, Volume 45, Issue 2 Author(s): Artur Jurczyszyn , Lidia Usnarska-Zubkiewicz , Anna Engel , Aleksandra Butrym , Grzegorz Mazur , Aleksander B. Skotnicki Multiple myeloma (MM) is a haematological disease characterized by plasma cells proliferation in bone marrow associated with damage of organs – mainly kidneys and bones. Previous therapies significantly extended the survival of patients, but still relapse is 100%. In February 2013, in USA, the Food and Drug Administration (FDA) introduced to therapy a new immunomodulatory drug – pomalidomide. In Eu...
Source: Acta Haematologica Polonica - October 12, 2014 Category: Hematology Source Type: research

Research in the CKD Clinic: Highs and Lows
Publication date: July 2014 Source:Advances in Chronic Kidney Disease, Volume 21, Issue 4 Author(s): Emily Decker , Jessica Kendrick Despite rates of CKD continuing to increase, the current evidence base used to guide CKD management is smaller than that for many other chronic diseases. Clinical investigators face multiple barriers to conducting research in patients with CKD. CKD patients have multiple comorbidities that make them a risky intervention target; thus, they are often excluded from trials. The lack of approved surrogate endpoints for kidney disease progression makes testing therapies to slow progression very c...
Source: Advances in Chronic Kidney Disease - October 12, 2014 Category: Urology & Nephrology Source Type: research

Dietary Counseling: The Ingredient for Successfully Addressing the Use of Herbal Supplements and Probiotics in Chronic Kidney Disease
This article will discuss some of the more commonly used products and their potential positive and adverse effects on CKD patients. (Source: Advances in Chronic Kidney Disease)
Source: Advances in Chronic Kidney Disease - October 12, 2014 Category: Urology & Nephrology Source Type: research

An update on prodrugs from natural products
Publication date: September 2014 Source:Asian Pacific Journal of Tropical Medicine, Volume 7, Supplement 1 Author(s): Sekar Vinoth Kumar , Devarajan Saravanan , Balasubramanian Kumar , Annamalai Jayakumar A natural prodrug is a chemical compound or substance obtained from plants, microorganism, animal and marine sources. Natural products are small molecule source for Food and Drug Administration approved drugs and major sources for drug discovery. Most of the drugs for different ailment diseases undergo first pass metabolism, resulting in drug inactivation and the generation of toxic metabolites in body. Enormous numbers...
Source: Asian Pacific Journal of Tropical Medicine - October 12, 2014 Category: Tropical Medicine Source Type: research

[Editorial] Health technologies and computer security
Fans of the American television drama Homeland may remember a scene in which the US vice-president is killed by an assassin who hacks into his wireless pacemaker and induces a fatal electric shock. This premise might sound fantastical, but the publication by the US Food and Drug Administration on Oct 2 of guidance on cybersecurity for medical devices suggests that such scenarios have moved beyond the realm of fiction and are of practical (albeit improbable) concern. The guidance is hardly sophisticated; mainly that manufacturers should include authentication, such as passwords, to restrict access to legitimate users, but m...
Source: LANCET - October 11, 2014 Category: Journals (General) Authors: The Lancet Tags: Editorial Source Type: research

Pharmacological Treatment of Chronic Non-Cancer Pain in Pediatric Patients.
This article reviews the major medications used for pediatric chronic pain conditions. PMID: 25304005 [PubMed - as supplied by publisher] (Source: Paediatric Drugs)
Source: Paediatric Drugs - October 11, 2014 Category: Pediatrics Authors: Mathew E, Kim E, Goldschneider KR Tags: Paediatr Drugs Source Type: research

Pharmacological Treatment of Chronic Non-Cancer Pain in Pediatric Patients
This article reviews the major medications used for pediatric chronic pain conditions. (Source: Pediatric Drugs)
Source: Pediatric Drugs - October 11, 2014 Category: Pediatrics Source Type: research

Gilead's next-generation hepatitis C pill wins FDA approval
Regulators approved Gilead Sciences Inc.'s next-generation hepatitis C drug Friday as the company's controversial breakthrough treatment continues to rack up sales. Harvoni — combining Sovaldi, the hep C drug that won Food and Drug Administration approval in December, with the drug ledipasvir — will cost $94,500 for a 12-week course of treatments for patients with genotype 1 infection or about $63,000 for an eight-week course, according to reports. Genotype 1 is the most common type of hepatitis… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - October 10, 2014 Category: Biotechnology Authors: Ron Leuty Source Type: research

Gilead's next-generation hepatitis C pill wins FDA approval
Regulators approved Gilead Sciences Inc.'s next-generation hepatitis C drug Friday as the company's controversial breakthrough treatment continues to rack up sales. Harvoni — combining Sovaldi, the hep C drug that won Food and Drug Administration approval in December, with the drug ledipasvir — will cost $94,500 for a 12-week course of treatments for patients with genotype 1 infection or about $63,000 for an eight-week course, according to reports. Genotype 1 is the most common type of hepatitis… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - October 10, 2014 Category: Hospital Management Authors: Ron Leuty Source Type: research

Evaluating Cardiovascular Safety of Novel Therapeutic Agents for the Treatment of Type 2 Diabetes Mellitus
Abstract Type 2 diabetes increases the risk of developing cardiovascular (CV) complications such as myocardial infarction, heart failure, stroke, peripheral vascular disease, and CV-associated mortality. Strict glycemic control in diabetics has shown improvement in microvascular complications related to diabetes but has been unable to demonstrate major effects on macrovascular complications including myocardial infarction and stroke. Conventional therapies for diabetes that include insulin, metformin, sulfonylureas (SU), and alpha-glucosidase inhibitors have limited and/or controversial data on CV safety based on...
Source: Current Cardiology Reports - October 10, 2014 Category: Cardiology Source Type: research