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FDA Issues Warning on Combined Use of Prescription Opioids, Benzodiazepines
The Food and Drug Administration todayannounced that it will require class-wide changes to the labels of all prescription opioid medications and benzodiazepines in an effort to inform health care providers and patients of the serious risks associated with the combined use of the medications.The agency will now require boxed warnings —the FDA’s strongest warning—and patient-focused Medication Guides for prescription opioid analgesics, opioid-containing cough products, and benzodiazepines (nearly 400 products in total), with information about the serious risks associated with using these medications at the same time.Th...
Source: Psychiatr News - August 31, 2016 Category: Psychiatry Tags: alcohol benzodiazepines boxed warnings CNS depressants FDA FDA MedWatch opioids safety announcement Source Type: research

Impact of the Food and Drug Administration (FDA) safety communication on morcellation on surgical practice and perioperative morbidity following myomectomy
To compare incidence, surgical approach, operative time, and perioperative morbidity following myomectomy before and after the FDA safety communication regarding power morcellation (Source: Fertility and Sterility)
Source: Fertility and Sterility - August 31, 2016 Category: Reproduction Medicine Authors: N.C. Stentz, L. Cooney, M.D. Sammel, D.K. Shah Tags: Poster session Source Type: research

Incidence of Occult Uterine Pathology in Women Undergoing Hysterectomy With Pelvic Organ Prolapse Repair
The objectives of this study are to determine the incidence of and associated risk factors for occult uterine pathology in patients undergoing hysterectomy with pelvic organ prolapse (POP) repair. Methods: Medical records were reviewed from all cases of hysterectomy with POP surgery at a tertiary medical center from January 2007 through July 2014. Exclusion criteria included known endometrial hyperplasia or malignancy. A power calculation determined that 1000 subjects would demonstrate a lower rate of leiomyosarcoma in a urogynecology population compared to the rate of 1:352 reported by the Food and Drug Administration. ...
Source: Female Pelvic Medicine and Reconstructive Surgery - August 31, 2016 Category: OBGYN Tags: Original Articles Source Type: research

[Correspondence] Brentuximab vedotin for CD30-positive tumours
According to a recent Review in The Lancet Oncology,1 only two antibody –drug conjugates have been approved by the US Food and Drug Administration (FDA)—brentuximab vedotin and ado-trastuzumab emtansine. Brentuximab vedotin was approved in 2011 and targets CD30-positive cells for the treatment of refractory Hodgkin's lymphoma and anaplastic large-cell lymphoma. Rece ntly, 5-year follow-up results were reported for patients with refractory Hodgkin's lymphoma showing that brentuximab vedotin had good disease control (41% overall survival and 22% progression-free survival; NCT00848926). (Source: The Lancet Oncology)
Source: The Lancet Oncology - August 31, 2016 Category: Cancer & Oncology Authors: Shigeo Masuda, Shigeru Miyagawa, Terumi Nakamura, Maaz Asher Khurram, Yoshiki Sawa Tags: Correspondence Source Type: research

Perioperative Management of a Leadless Pacemaker: The Paucity of Evidence-Based Guidelines
LEADLESS CARDIAC PACEMAKERS recently have been shown to be safe, and their use may change the care requirements of pacing-dependent patients.1,2 With the introduction of new implanted technology capable of affecting patient hemodynamics, anesthesiologists must acquire knowledge of appropriate and intended device function and behavior in the perioperative period. Despite recent approval of a leadless device by the Food and Drug Administration (FDA), currently no substantial clinical data exists for guidelines, an expert consensus statement, or a practice advisory in the perioperative management of patients with these leadle...
Source: Journal of Cardiothoracic and Vascular Anesthesia - August 31, 2016 Category: Anesthesiology Authors: Gregory J. Mickus, George I. Soliman, Ryan R. Reed, Archer K. Martin Source Type: research

Development of RP-HPLC method for simultaneous determination of docetaxel and curcumin in rat plasma: validation and stability
Publication date: Available online 31 August 2016 Source:Asian Journal of Pharmaceutical Sciences Author(s): Dong Wuk Kim, Abid Mehmood Yousaf, Dong Xun Li, Jong Oh Kim, Chul Soon Yong, Kwan Hyung Cho, Han-Gon Choi The purpose of the present research was to develop a suitable, simple, precise, accurate, robust, and reproducible RP-HPLC method for a reliable simultaneous quantification of docetaxel (DTX) and curcumin (CCM) in the rat plasma samples using paclitaxel (PTX) as an internal standard. The samples were assayed by the Agilent 1260 Infinity HPLC instrument using a Capcell Pak C8 column (4.6 mm x 150 mm, 5 µm) unde...
Source: Asian Journal of Pharmaceutical Sciences - August 31, 2016 Category: Drugs & Pharmacology Source Type: research

Multidimensional Diagnostic Criteria for Chronic Pain: Introduction to the ACTTION –American Pain Society Pain Taxonomy (AAPT)
A variety of approaches have been used to develop diagnostic criteria for chronic pain. The published evidence of the reliability and validity of existing diagnostic criteria is limited, and these criteria have typically not been used in clinical practice. The availability of a widely accepted, consistently applied, and evidence-based taxonomy of diagnostic criteria would improve the quality of clinical research on chronic pain and would be of great value in clinical practice. To address the need for evidence-based diagnostic criteria for the major chronic pain conditions, the Analgesic, Anesthetic, and Addiction Clinical ...
Source: The Journal of Pain - August 30, 2016 Category: Materials Science Authors: Robert H. Dworkin, Stephen Bruehl, Roger B. Fillingim, John D. Loeser, Gregory W. Terman, Dennis C. Turk Source Type: research

Comparison of Outcomes before and after Ohio's Law Mandating Use of the FDA-Approved Protocol for Medication Abortion: A Retrospective Cohort Study
The objective of this study is to examine the association of this legal change with medication abortion outcomes and utilization. Methods and FindingsWe used a retrospective cohort design, comparing outcomes of medication abortion patients in the prelaw period to those in the postlaw period. Sociodemographic and clinical chart data were abstracted from all medication abortion patients from 1 y prior to the law ’s implementation (January 2010–January 2011) to 3 y post implementation (February 2011–October 2014) at four abortion-providing health care facilities in Ohio. Outcome data were analyzed for all women undergoi...
Source: PLoS Medicine - August 30, 2016 Category: Internal Medicine Authors: Ushma D. Upadhyay Source Type: research

Post-Marketing Safety Events Relating to New Drugs Approved in Brazil Between 2003 and 2013: A Retrospective Cohort Study.
This study investigated post-marketing safety events (PMSE) for new drugs approved in Brazil and evaluated whether a range of drug characteristics influenced the time between approval and the first PMSE. This retrospective study included new drugs registered between 2003 and 2013 by the National Health Surveillance Agency (ANVISA), which is responsible for medicines approval in Brazil. PMSE were defined as any drug safety alert or drug withdrawal from the market. The existence of risk evaluation and mitigation strategies (REMS) in the United States Food and Drug Administration (FDA) and Brazil were recorded. A Kaplan-Meier...
Source: The Journal of Clinical Pharmacology - August 29, 2016 Category: Drugs & Pharmacology Authors: Botelho SF, Martins MA, Vieira LB, Moreira Reis AM Tags: J Clin Pharmacol Source Type: research

Effect of CYP2C9 and VKORC1 Gene Variants on Warfarin Response in Patients with Continuous-Flow Left Ventricular Assist Devices
Bleeding and thrombotic complications continue to plague continuous-flow left ventricular assist device (CF-LVAD) therapy in patients with end-stage heart failure. Warfarin genotyping information can be incorporated into decision making for initial dosing as recommended by the Food and Drug Administration; however, clinical utility of this data in the CF-LVAD population has not been well studied. Genotypes testing for CYP2C9 and VCORC1 polymorphisms were determined in 90 CF-LVAD patients. Outcomes studied were the association of CYP2C9 (*1, *2, or *3) and VKORC1 (-1639 G>A) gene variants with time-to-target international n...
Source: ASAIO Journal - August 27, 2016 Category: Medical Equipment Tags: Adult Circulatory Support Source Type: research

Prevention and Control of Seasonal Influenza with Vaccines.
This report updates the 2015-16 recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding the use of seasonal influenza vaccines (Grohskopf LA, Sokolow LZ, Olsen SJ, Bresee JS, Broder KR, Karron RA. Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices, United States, 2015-16 influenza season. MMWR Morb Mortal Wkly Rep 2015;64:818-25). Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. For the 2016-17 influenza season, inactivated influenza vaccines (IIVs) will be ...
Source: MMWR Recomm Rep - August 27, 2016 Category: Epidemiology Authors: Grohskopf LA, Sokolow LZ, Broder KR, Olsen SJ, Karron RA, Jernigan DB, Bresee JS Tags: MMWR Recomm Rep Source Type: research

Integration of new technology into clinical practice after FDA approval
AbstractDevelopment of new medical technology is a crucial part of the advancement of medicine and our ability to better treat patients and their diseases. This process of development is long and arduous and requires a significant investment of human, financial and material capital. However, technology development can be rewarded richly by its impact on patient outcomes and successful sale of the product. One of the major regulatory hurdles to technology development is the Food and Drug Administration (FDA) approval process, which is necessary before a technology can be marketed and sold in the USA. Many businesses, medica...
Source: Journal of Interventional Cardiac Electrophysiology - August 27, 2016 Category: Cardiology Source Type: research

Management of Hypercholesterolemia, Appropriateness of Therapeutic Approaches and New Drugs in Patients with High Cardiovascular Risk
AbstractControl of lipid levels is one of the most effective strategies for cardiovascular (CV) event prevention. In fact, many clinical trials have clearly demonstrated that low-density lipoprotein cholesterol (LDL-C) lowering, primarily with statins, reduces major CV events and mortality. The evidence from these trials has been useful in designing the cholesterol treatment guidelines, which are mainly aimed at preventing and managing cardiovascular disease (CVD). However, available data indicate that a large proportion of patients fail to achieve lipid goals, and this is particularly frequent in patients at high or very ...
Source: High Blood Pressure and Cardiovascular Prevention - August 27, 2016 Category: Cardiology Source Type: research

Preclinical PET Neuroimaging of [11C]Bexarotene.
In this study, the brain uptake and saturability of [(11)C]bexarotene were studied in rats and nonhuman primates by PET imaging under baseline and greater target occupancy conditions. [(11)C]Bexarotene displays a high proportion of nonsaturable uptake in the brain and is unsuitable for RXR occupancy measurements in the central nervous system. PMID: 27553293 [PubMed - in process] (Source: Molecular Imaging)
Source: Molecular Imaging - August 26, 2016 Category: Radiology Tags: Mol Imaging Source Type: research

Food and Drug Administration approval of sustained ‐release buprenorphine for treatment of opioid dependence: realizing its potential
(Source: Addiction)
Source: Addiction - August 26, 2016 Category: Addiction Authors: Stacey C. Sigmon, George E. Bigelow Tags: Editorial Source Type: research

Association of tree nut and coconut sensitization
Coconut (Cocos nucifera), despite being a drupe, was added to the US Food and Drug Administration list of tree nuts in 2006, causing potential confusion regarding the prevalence of coconut allergy among tree nut allergic patients. (Source: Annals of Allergy, Asthma and Immunology)
Source: Annals of Allergy, Asthma and Immunology - August 26, 2016 Category: Allergy & Immunology Authors: Brooke I. Polk, Deendayal Dinakarpandian, Maya Nanda, Charles Barnes, Chitra Dinakar Source Type: research

Regulation of New Drug Approval in Taiwan
This article summarizes the efforts TFDA has been making in the domain of medicinal product management, highlighting policies and strategies for the future. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - August 26, 2016 Category: Drugs & Pharmacology Authors: Yang, Y.-T., Huang, H.-W., Chen, Y.-T., Chiang, Y.-M., Tzou, M.-C. Tags: Global Perspectives Source Type: research

Product Development Under FDAs Animal Rule: Understanding FDAs Expectations and Potential Implications for Traditional Development Programs
This article reviews how different products met the requirements for licensure under the Animal Rule, based on information publicly available on FDA’s website. The primary aim of this manuscript is to offer an understanding of FDA’s interpretation of relevant regulations and guidances in the context of this licensure pathway. Some of the methods used for Animal Rule approvals may also have potential application in more traditional development programs. Thus, this article may also offer insight into methods for accelerating product development in general. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - August 26, 2016 Category: Drugs & Pharmacology Authors: Allio, T. Tags: Regulatory Science Source Type: research

Citalopram dose reductions in response to safety warning increased hospitalization
A group of Department of Veterans Affairs (VA) patients who had their citalopram doses reduced after a federal safety communication about doses exceeding 40 mg/day experienced a significant increase in hospitalizations and deaths compared with patients whose doses were not reduced, a study has found. The study's authors suggested that the Food and Drug Administration's (FDA's) 2011 safety communication appears to have generated unintended clinical consequences. Study results were published online May 10 in the American Journal of Psychiatry. (Source: The Brown University Psychopharmacology Update)
Source: The Brown University Psychopharmacology Update - August 25, 2016 Category: Psychiatry Tags: Adverse Events Source Type: research

The acute anorexic effect of liraglutide, a GLP-1 receptor agonist, does not require functional leptin receptor, serotonin, and hypothalamic POMC and CART activities in mice
A high dose of liraglutide (3 mg), a human glucagon-like-peptide-1 (GLP-1) analog, which treats type 2 diabetes, was recently approved by the European Medicines Agency and United States Food and Drug Administration for weight reduction in human obesity [1]. (Source: Diabetes Research and Clinical Practice)
Source: Diabetes Research and Clinical Practice - August 25, 2016 Category: Endocrinology Authors: Katsunori Nonogaki, Takao Kaji Source Type: research

Potential of L-thyroxine to differentiate osteoblast-like cells via Angiopoietin1.
In this study, we aimed to identify a novel drug that can activate endogenous Ang1 expression as a pharmacological treatment for bone formation. Therefore, Ang1 expression was examined in U2OS osteoblast-like cells treated with 770 drugs from a library of Food and Drug Administration (FDA)-approved drugs by using ELISA for Ang1. L-thyroxine was selected as a novel drug candidate. L-thyroxine is a synthetic form of the hormone thyroxine, which is used to treat patients with hypothyroidism. Enzyme-linked immunosorbent assays (ELISAs) were performed to test whether Ang1 is induced in a dose-dependent manner in human osteoblas...
Source: Biochemical and Biophysical Research communications - August 25, 2016 Category: Biochemistry Authors: Park SH, Lee J, Kang MA, Moon YJ, Wang SI, Kim KM, Park BH, Jang KY, Kim JR Tags: Biochem Biophys Res Commun Source Type: research

Gliadel wafer implantation combined with standard radiotherapy and concurrent followed by adjuvant temozolomide for treatment of newly diagnosed high-grade glioma: a systematic literature review
Since 2003, only two chemotherapeutic agents, evaluated in phase III trials, have been approved by the US Food and Drug Administration for treatment of newly diagnosed high-grade glioma (HGG): Gliadel wafers (... (Source: World Journal of Surgical Oncology)
Source: World Journal of Surgical Oncology - August 24, 2016 Category: Cancer & Oncology Authors: Lynn S. Ashby, Kris A. Smith and Baldassarre Stea Source Type: research

Exosomal MicroRNAs Derived From Umbilical Mesenchymal Stem Cells Inhibit Hepatitis C Virus Infection
Hepatitis C virus (HCV) is a significant global public health problem, causing more than 350,000 deaths every year. Although the development of direct-acting antivirals has improved the sustained virological response rate in HCV patients, novel anti-HCV agents with higher efficacy as well as better tolerance and cheaper production costs are still urgently needed. Cell-based therapy, especially its unique and strong paracrine ability to transfer information to other cells via extracellular vesicles such as exosomes, has become one of the most popular therapeutic methods in recent years. In our study, exosomes secreted from ...
Source: Stem Cells Translational Medicine - August 24, 2016 Category: Stem Cells Authors: Qian, X., Xu, C., Fang, S., Zhao, P., Wang, Y., Liu, H., Yuan, W., Qi, Z. Tags: Cord Blood Stem Cells, Tissue-Specific Progenitor and Stem Cells Source Type: research

Bioactive natural products in cancer prevention and therapy: Progress and promise
Publication date: Available online 23 August 2016 Source:Seminars in Cancer Biology Author(s): Anupam Bishayee, Gautam Sethi Natural products represent a rich source for the discovery and development of cancer preventive and anticancer drugs. Nearly, 80% of all drugs approved by the United States Food and Drug Administration during the last three decades for cancer therapy are either natural products per se or are based thereon, or mimicked natural products in one form or another. With the advent and refinement of new technologies, such as genetic techniques for production of secondary plant metabolites, combinatorial syn...
Source: Seminars in Cancer Biology - August 24, 2016 Category: Cancer & Oncology Source Type: research

New Gram-Positive Agents: the Next Generation of Oxazolidinones and Lipoglycopeptides [Minireviews]
The growing problem of antimicrobial resistance among bacterial pathogens, including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE), has reached a critical state. Tedizolid phosphate, dalbavancin, and oritavancin have recently been approved by the U.S. Food and Drug Administration (FDA) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and represent the next generation of oxazolidinones and lipoglycopeptides. All three agents exhibit in vitro activity and clinical efficacy against MRSA. Tedizolid phosphate and oritavancin demonstrate in vitro act...
Source: Journal of Clinical Microbiology - August 24, 2016 Category: Microbiology Authors: Crotty, M. P., Krekel, T., Burnham, C.-A. D., Ritchie, D. J. Tags: Minireviews Source Type: research

FDA Approves Devices for Assessing Cognitive Function After Brain Injury
Two devices for assessing cognitive function immediately following a suspected brain injury or concussion wereapproved for marketing by the Food and Drug Administration (FDA) yesterday.The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the first medical devices permitted for marketing that are intended to assess cognitive function following a possible concussion, according to the FDA. They are intended as part of the medical evaluation that doctors perform to assess signs and symptoms of a head injury.“These devices provide a useful new tool to aid in the evaluation of p...
Source: Psychiatr News - August 23, 2016 Category: Psychiatry Tags: brain injury cognitive function concussion FDA FDA approval ImPACT Source Type: research

Power morcellation dropped, abdominal hysterectomy increased after FDA warning
Electric power morcellation during hysterectomy declined sharply after the Food and Drug Administration discouraged use of the technique in April 2014 and then recommended against it for... (Source: Ob.Gyn. News)
Source: Ob.Gyn. News - August 23, 2016 Category: OBGYN Source Type: research

The ROADSTER Investigational Device Exemption Trial Leads to Food and Drug Administration Approval of the First Stent Labeled for Trans-Carotid Artery Revascularization
Trans-carotid artery revascularization (TCAR) with the ENROUTE Transcarotid Neuroprotection System (Silk Road Medical, Sunnyvale, Calif) combines direct carotid access with blood flow reversal as cerebral protection during carotid stent placement. The Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) investigational device exemption trial studied TCAR using Food and Drug Administration (FDA)-approved carotid stent systems designed for transfemoral delivery. (Source: Journal of Vascular Surgery)
Source: Journal of Vascular Surgery - August 23, 2016 Category: Surgery Authors: Manish Mehta, Vikran Kashyap, Mahmoud Malas, Philip Paty, Richard Cambria, Christopher Kwolek, Rasesh Shah, Enrique Criado, Robert Molnar Tags: Abstract from the 2016 Eastern Vascular Society Annual Meeting Source Type: research

Trends in Use and Outcomes of Women Undergoing Hysterectomy With Electric Power Morcellation
This surgical epidemiology examines trends in the type of hysterectomy, use of electric power morcellators, and prevalence of abnormal pathology before and after the US Food and Drug Administration ’s 2014 guidance recommending against use of electric morcellation. (Source: JAMA)
Source: JAMA - August 23, 2016 Category: Journals (General) Source Type: research

Summaries of safety labeling changes approved by FDA-boxed warnings highlights March-June 2016.
PMID: 27543581 [PubMed - in process] (Source: American Journal of Health-System Pharmacy : AJHP)
Source: American Journal of Health-System Pharmacy : AJHP - August 22, 2016 Category: Drugs & Pharmacology Authors: Office of Health & Constituent Affairs U.S. Food and Drug Administration Tags: Am J Health Syst Pharm Source Type: research

Summaries of safety labeling changes approved by FDA-boxed warnings highlights April-June 2016.
PMID: 27543571 [PubMed - in process] (Source: American Journal of Health-System Pharmacy : AJHP)
Source: American Journal of Health-System Pharmacy : AJHP - August 22, 2016 Category: Drugs & Pharmacology Authors: Office of Health & Constituent Affairs, U.S. Food and Drug Administration Tags: Am J Health Syst Pharm Source Type: research

Identification of nafamostat as a potent inhibitor of Middle East respiratory syndrome (MERS) corona virus S-mediated membrane fusion using the split protein-based cell-cell fusion assay.
Abstract Middle East respiratory syndrome (MERS) is an emerging infectious disease associated with a relatively high mortality rate of approximately 40%. MERS is caused by MERS corona virus (MERS-CoV) infection, and no specific drugs or vaccines are currently available to prevent MERS-CoV infection. MERS-CoV is an enveloped virus and its envelope protein (S protein) mediates membrane fusion at the plasma membrane or endosomal membrane. Multiple proteolysis by host proteases, such as furin, transmembrane protease serine 2 (TMPRSS2), and cathepsins, causes the S protein to become fusion competent. TMPRSS2, which is ...
Source: Antimicrobial Agents and Chemotherapy - August 22, 2016 Category: Microbiology Authors: Yamamoto M, Matsuyama S, Li X, Takeda M, Kawaguchi Y, Inoue JI, Matsuda Z Tags: Antimicrob Agents Chemother Source Type: research

Cross-species prediction of human survival probabilities for accelerated anthrax vaccine absorbed (AVA) regimens and the potential for vaccine and antibiotic dose sparing.
Abstract Anthrax vaccine adsorbed (AVA, BioThrax) was recently approved by the Food and Drug Administration (FDA) for a post-exposure prophylaxis (PEP) indication in adults 18-65years of age. The schedule is three doses administered subcutaneous (SC) at 2-week intervals (0, 2, and 4weeks), in conjunction with a 60-day course of antimicrobials. The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) developed an animal model to support assessment of a shortened antimicrobial PEP duration following Bacillus anthracis exposure. A nonhuman primate (NHP) study was completed to evaluate the efficacy of a...
Source: Vaccine - August 22, 2016 Category: Allergy & Immunology Authors: Stark GV, Sivko GS, VanRaden M, Schiffer J, Taylor KL, Hewitt JA, Quinn CP, Nuzum EO Tags: Vaccine Source Type: research

Grazoprevir/elbasvir fixed-dose combination for hepatitis C.
Authors: Gamal N, Andreone P Abstract Hepatitis C virus (HCV) infection is an increasing public health concern with an estimated 184 million people infected worldwide and approximately 350,000 deaths yearly from HCV-related complications. There is a compelling medical need for new anti-HCV therapeutic agents that are potent, tolerable, safe, completely oral and with shorter treatment duration. To this end, a plethora of direct-acting antivirals have been developed and regulatory authorities have approved nine new molecules for the treatment of chronic hepatitis C (CHC). In January 2016, the U.S. Food and Drug Admin...
Source: Drugs of Today - August 21, 2016 Category: Drugs & Pharmacology Tags: Drugs Today (Barc) Source Type: research

Development of a rapid multiresidue analysis method for β-agonists in muscle and viscera
Publication date: Available online 8 August 2016 Source:Journal of Food and Drug Analysis Author(s): Yen-Ping Lin, Ying-Lin Lee, Chien-Ya Hung, Wen-Jeng Huang, Sheng-Che Lin The official analytical method of the Taiwan Food and Drug Administration, Ministry of Health and Welfare for testing for veterinary drug residues in foods is the multiresidue analysis of β-agonists. Samples are pretreated through liquid–liquid extraction and solid-phase extraction. This method is time consuming and requires the intensive use of solvents. To improve analytical efficiency and reduce costs, our study incorporated QuEChERS (Quick, Eas...
Source: Journal of Food and Drug Analysis - August 21, 2016 Category: Food Science Source Type: research

Contact Lens-Related Corneal Infections - United States, 2005-2015.
Abstract Keratitis (inflammation of the cornea) can result from contact lens wear or other causes. Keratitis from all causes, including contact lens wear, results in approximately 1 million clinic and emergency department visits annually, with an estimated cost of $175 million in direct health care expenditures in 2010 (1). Approximately 41 million U.S. residents wear contact lenses, and in 2014, >99% of contact lens wearers surveyed reported at least one behavior that puts them at risk for a contact lens-related eye infection (2). The Center for Devices and Radiological Health at the Food and Drug Administrati...
Source: MMWR Morb Mortal Wkl... - August 20, 2016 Category: Epidemiology Authors: Cope JR, Collier SA, Srinivasan K, Abliz E, Myers A, Millin CJ, Miller A, MS, Tarver ME Tags: MMWR Morb Mortal Wkly Rep Source Type: research

Tobacco Advertising and Promotional Expenditures in Sports and Sporting Events - United States, 1992-2013.
Abstract Smokeless tobacco has been actively promoted by tobacco companies using endorsements by major sport figures, and research indicates that tobacco advertising can lead to youth initiation of tobacco use (1,2). Television and radio advertisements for cigarettes and smokeless tobacco have been prohibited since 1969,* and the 1998 Master Settlement Agreement(†) further prohibited tobacco companies from targeting youths with tobacco product advertisements in specified areas. In 2010, the Food and Drug Administration (FDA), under authority of the 2009 Family Smoking Prevention and Tobacco Control Act (FSPTCA),...
Source: MMWR Morb Mortal Wkl... - August 20, 2016 Category: Epidemiology Authors: Agaku IT, Odani S, Sturgis S, Harless C, Glover-Kudon R Tags: MMWR Morb Mortal Wkly Rep Source Type: research

Calcium Hydroxylapatite With Integral Lidocaine Provides Improved Pain Control for the Correction of Nasolabial Folds.
Authors: Schachter D, Bertucci V, Solish N Abstract Calcium hydroxylapatite microspheres in a carrier gel (CaHA; Radiesse®: Merz North America, Inc., Raleigh, NC) is approved by the United States Food and Drug Administration for subdermal implantation for the correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds (NLFs). Lidocaine is often mixed with injectable dermal fillers to reduce injection pain. A new formulation of CaHA has been developed with the convenience of integral 0.3% lidocaine, CaHA (+).<br /> This multicenter, split-face, double-blind study randomized subjects t...
Source: Journal of Drugs in Dermatology - August 20, 2016 Category: Dermatology Tags: J Drugs Dermatol Source Type: research

Alternative Method to Remove Polyethylene Liner from INBONE Total Ankle Arthroplasty: Operative Technique
Total ankle arthroplasty (TAA) is an evolving treatment indicated in end-stage idiopathic, posttraumatic, or inflammatory ankle arthrosis. Currently, there are 4 Food and Drug Administration approved TAAs systems available in the United States, one of which is the INBONE TAA. The INBONE TAA is a third generation ankle implant that has been approved by the Food and Drug Administration since 2005. It is a modular, fixed-bearing system that utilizes a drill hole through the calcaneus and talus to align the components. Over the past 10 years, there has been a steady increase in the number of TAAs performed in the United States...
Source: Techniques in Foot and Ankle Surgery - August 19, 2016 Category: Orthopaedics Tags: Technique Source Type: research

CK2{alpha} Maintains ERK Activity to Promote Inhibitor Resistance [Signal Transduction]
The protein kinase casein kinase 2 (CK2) is a pleiotropic and constitutively active kinase that plays crucial roles in cellular proliferation and survival. Overexpression of CK2, particularly the α catalytic subunit (CK2α, CSNK2A1), has been implicated in a wide variety of cancers and is associated with poorer survival and resistance to both conventional and targeted anticancer therapies. Here, we found that CK2α protein is elevated in melanoma cell lines compared with normal human melanocytes. We then tested the involvement of CK2α in drug resistance to Food and Drug Administration-approved single agent targeted thera...
Source: Journal of Biological Chemistry - August 19, 2016 Category: Chemistry Authors: Zhou, B., Ritt, D. A., Morrison, D. K., Der, C. J., Cox, A. D. Tags: Signal Transduction Source Type: research

Early history of LGBT tobacco control: CLASH at 25
In the spring of 2016, the Food and Drug Administration (FDA) launched a national campaign, This Free Life, to discourage lesbian, gay, bisexual and transgender (LGBT) people from smoking (see front cover). This Free Life would have been only a fantasy 25 years ago, when a few LGBT advocates met during the campaign that made San Francisco restaurants smoke-free. They suspected that LGBT smoking rates were high and founded the first organisation dedicated to LGBT tobacco control, the Coalition of Lavender-Americans on Smoking or Health (CLASH). Its mission was three-pronged: to work within the LGBT community to raise a...
Source: Tobacco Control - August 19, 2016 Category: Respiratory Medicine Authors: Offen, N., Smith, E. A., Gordon, B. Tags: Editorial Source Type: research

A cigar by any other name would taste as sweet
We examined trends in flavoured cigar sales between 2008 and 2014 with Nielsen's Convenience Track System data, using previously described methods.1 We coded flavours into key categories, including: fruit, sweet/candy, wine, liquor, clove, menthol and ‘other.’ figure 1 depicts flavoured market... (Source: Tobacco Control)
Source: Tobacco Control - August 19, 2016 Category: Respiratory Medicine Authors: Viola, A. S., Giovenco, D. P., Miller Lo, E. J., Delnevo, C. D. Tags: Research letter Source Type: research

The anti-inflammatory role of minocycline in Alzheimer ´s Disease.
The anti-inflammatory role of minocycline in Alzheimer´s Disease. Curr Alzheimer Res. 2016 Aug 19; Authors: Budni J, Garcez ML, de Medeiros J, Cassaro E, Santos-Bellettini T, Mina F, Quevedo J Abstract Alzheimer's disease (AD) is a neurodegenerative disorder, the most common form of dementia in elderly. Although, AD has been discovered over a century ago, the drugs approved by the US Food and Drug Administration are not yet fully effective in the AD treatment. Current evidence suggests that the antibiotic minocycline could be a potential therapeutic drug for use in the AD treatment due to its anti-ne...
Source: Current Alzheimer Research - August 19, 2016 Category: Neurology Authors: Budni J, Garcez ML, de Medeiros J, Cassaro E, Santos-Bellettini T, Mina F, Quevedo J Tags: Curr Alzheimer Res Source Type: research

Oncofertility considerations in adolescents and young adults given a diagnosis of melanoma: Fertility risk of Food and Drug Administration –approved systemic therapies
Melanoma is the most common cancer diagnosed for patients ages 25 to 29  years, the group with the highest birth rates in the United States. Oncofertility is a new field addressing the reproductive needs of patients with cancer facing fertility-threatening treatments. (Source: Journal of the American Academy of Dermatology)
Source: Journal of the American Academy of Dermatology - August 18, 2016 Category: Dermatology Authors: Jessica R. Walter, Shuai Xu, Amy S. Paller, Jennifer N. Choi, Teresa K. Woodruff Tags: Original article Source Type: research

Dependence symptoms and cessation intentions among US adult daily cigarette, cigar, and e-cigarette users, 2012-2013
Cigar and e-cigarette use is becoming increasingly common among US tobacco users and the Food and Drug Administration recently asserted regulatory jurisdiction over these products, among others, in May 2016. R... (Source: BMC Public Health)
Source: BMC Public Health - August 18, 2016 Category: Consumer Health News Authors: Brian L. Rostron, Megan J. Schroeder and Bridget K. Ambrose Source Type: research

Drug shortages: Patients and healthcare providers are all drawing the short straw
Publication date: Available online 17 August 2016 Source:Canadian Journal of Cardiology Author(s): François Rinaldi, Simon de Denus, Angela Nguyen, Stanley Nattel, Jean-François Bussières Drug shortages have been reported for more than thirty-five years. Attention to this problem increased recently following the Sandoz crisis, in which a warning letter by the Food and Drug Administration caused supply changes that suspended the availability of numerous medications. The frequency of drug shortages has increased recently. In 2011-2012 alone, Canadian supply shortages occurred for over 1000 drugs (including 150 for cardio...
Source: Canadian Journal of Cardiology - August 18, 2016 Category: Cardiology Source Type: research

The Impact of Collagenase Clostridium histolyticum Introduction on Dupuytren Treatment Patterns in the United States
This study addresses the impact of that approval on the number of Dupuytren contracture (DC) encounters and treatment patterns in the United States. (Source: The Journal of Hand Surgery)
Source: The Journal of Hand Surgery - August 18, 2016 Category: Surgery Authors: John Z. Zhao, Scott Hadley, Emerson Floyd, Brandon E. Earp, Philip E. Blazar Tags: Scientific article Source Type: research

Cosmetics use and age at menopause: is there a connection?
Cosmetics contain a vast number of chemicals, most of which are not under the regulatory purview of the Food and Drug Administration. Only a few of these chemicals have been evaluated for potential deleterious health impact: parabens, phthalates, polycyclic aromatic hydrocarbons, and siloxanes. A review of the ingredients in the best-selling and top-rated products of the top beauty brands in the world, as well as a review of highlighted chemicals by nonprofit environmental organizations, reveals 11 chemicals and chemical families of concern: butylated hydroxyanisole/butylated hydroxytoluene, coal tar dyes, diethanolamine, ...
Source: Fertility and Sterility - August 18, 2016 Category: Reproduction Medicine Authors: Erika Chow, Shruthi Mahalingaiah Tags: Endocrine-disrupting chemicals and reproductive disorders Source Type: research

A hard look at FDA ’s review of GRAS notices
Publication date: 31 August 2016 Source:Regulatory Toxicology and Pharmacology, Volume 79, Supplement 2 Author(s): Ashley Roberts, Lois A. Haighton Generally Recognized as Safe (GRAS) substances are exempt from premarket approval; however, the standard of “reasonable certainty of no harm” is the same. In 1997, the voluntary GRAS affirmation process was replaced with the voluntary U.S. Food and Drug Administration (FDA) GRAS notice process. Under the GRAS notice process, pivotal safety data are required to be in the public domain, and consensus of safety among experts is required. FDA issues responses of “FDA has no ...
Source: Regulatory Toxicology and Pharmacology - August 18, 2016 Category: Toxicology Source Type: research

Targeting Angiogenesis in Cancer Treatments: Where do we Stand?
This article is open to POST-PUBLICATION REVIEW. Registered readers (see "For Readers") may comment by clicking on ABSTRACT on the issue's contents page. PMID: 27518172 [PubMed - in process] (Source: Journal of Pharmacy and Pharmaceutical Sciences)
Source: Journal of Pharmacy and Pharmaceutical Sciences - August 17, 2016 Category: Drugs & Pharmacology Tags: J Pharm Pharm Sci Source Type: research