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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 25, 2014 Category: Pediatrics Authors: Thomas R. Welch Tags: The Editors' Perspectives 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

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

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

[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

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

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

Alcohol involvement in opioid pain reliever and benzodiazepine drug abuse-related emergency department visits and drug-related deaths - United States, 2010.
Abstract The abuse of prescription drugs has led to a significant increase in emergency department (ED) visits and drug-related deaths over the past decade. Opioid pain relievers (OPRs) and benzodiazepines are the prescription drugs most commonly involved in these events. Excessive alcohol consumption also accounts for a significant health burden and is common among groups that report high rates of prescription drug abuse. When taken with OPRs or benzodiazepines, alcohol increases central nervous system depression and the risk for overdose. Data describing alcohol involvement in OPR or benzodiazepine abuse are limi...
Source: MMWR Morb Mortal Wkl... - October 10, 2014 Category: Epidemiology Authors: Jones CM, Paulozzi LJ, Mack KA Tags: MMWR Morb Mortal Wkly Rep Source Type: research

Aluminum contamination in parenteral products
Purpose of reviewIn 1986, the US Food and Drug Administration issued an aluminum mandate in hopes of minimizing patient exposure to aluminum contaminates contained in parenteral nutrition additives. The purpose of this article is to revisit the status of aluminum contamination as it relates to parenteral nutrition and to survey the recent literature to determine if any new findings have emerged. A special emphasis will be placed on the complications associated with aluminum toxicity. Recent findingsIn addition to metabolic bone disease, patients with aluminum toxicity are also prone to other complications such as neurodeve...
Source: Current Opinion in Clinical Nutrition and Metabolic Care - October 9, 2014 Category: Nutrition Tags: MICRONUTRIENTS: Edited by Henry C. Lukaski and Gil Hardy Source Type: research

Digest
US new drug approvals The US Food and Drug Administration has granted marketing approval to several compounds ahead of their European regulatory counterpart. Lacosamide (Vimpat) is now approved as monotherapy for partial onset seizures in patients aged over 17. In Europe it is currently limited to adjunctive therapy, though a monotherapy indication will be pursued pending the outcome of a comparative trial against carbamazepine. Peginterferon beta‐1a (Plegridy), administered as a fortnightly subcutaneous injection, has been approved for relapsing forms of multiple sclerosis. Eliglustat (Cerdelga) has been approved for th...
Source: Progress in Neurology and Psychiatry - October 9, 2014 Category: Neurology Tags: Digest Source Type: research

A validated LC-MS/MS assay for simultaneous quantification of methotrexate and tofacitinib in rat plasma: application to a pharmacokinetic study.
Abstract A highly sensitive, specific and rapid LC-ESI-MS/MS method has been developed and validated for simultaneous quantification of methotrexate (MTX) and tofacitinib (TFB) in rat plasma (50 μL) using phenacetin as an internal standard (IS), as per the US Food and Drug Administration guidelines. After a solid-phase extraction procedure, the separation of the analytes and IS was performed on a Chromolith RP18e column using an isocratic mobile phase of 5 mm ammonium acetate (pH 5.0) and acetonitrile at a ratio of 25:75 (v/v) using flow-gradient with a total run time of 3.5 min. The detection was performed in mul...
Source: Biomedical Chromatography : BMC - October 9, 2014 Category: Biomedical Science Authors: Sharma K, Giri K, Dhiman V, Dixit A, Zainuddin M, Mullangi R Tags: Biomed Chromatogr Source Type: research

Dimethyl fumarate protection against collagen II degradation.
In this study, we found that DMF ameliorated collagen type II degradation by inhibiting the expression of MMP-1, MMP-3, and MMP-13 caused by TNF-α. Mechanistically, DMF attenuated MMPs expression by suppressing JAK/STAT3 pathway. These findings imply that DMF treatment might be a potential therapeutic strategy for chondroprotective therapy. PMID: 25305493 [PubMed - as supplied by publisher] (Source: Biochemical and Biophysical Research communications)
Source: Biochemical and Biophysical Research communications - October 8, 2014 Category: Biochemistry Authors: Li Y, Tang J, Hu Y Tags: Biochem Biophys Res Commun Source Type: research

A synthetic stimulant never tested in humans, 1,3‐dimethylbutylamine (DMBA), is identified in multiple dietary supplements
A synthetic stimulant never before studied in humans, 1,3‐dimethylbutylamine (DMBA), was suspected of being present in dietary supplements. DMBA is an analogue of the pharmaceutical stimulant, 1,3‐dimethylamylamine (DMAA), which was recently banned by the US Food and Drug Administration. We obtained all dietary supplements sold by US distributors that listed an ingredient on the label, such as AMP Citrate, that might be a marketing name for DMBA. Supplements were analyzed for the presence and quantity of DMBA. Fourteen supplements met our inclusion criteria and were analyzed by two separate laboratories using ultra hig...
Source: Drug Testing and Analysis - October 8, 2014 Category: Drugs & Pharmacology Authors: Pieter A. Cohen, John C. Travis, Bastiaan J. Venhuis Tags: Short communication Source Type: research

Durham's Chimerix offers potential drug to fight Ebola
At the request of physicians fighting Ebola, North Carolina drug developer Chimerix Inc. will offer an experimental drug as potential treatment for the deadly virus. The U.S. Food and Drug Administration granted Chimerix (NASDAQ:CMRX) Emergency Investigational New Drug Applications, in which a drug that has not received FDA approval may be used in an emergency situation if physicians make the request. Durham-based Chimerix will work to develop a clinical trial to test the safety, tolerability and… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - October 7, 2014 Category: American Health Authors: Jason deBruyn Source Type: research

CardioPulse Articles * Training of cardiologists in China: catching up with the rest of the world * The Great Wall International Congress of Cardiology 2014 * Firehawk(R) sirolimus target-eluting coronary stent approved by China Food and Drug Administration * Hybrid coronary revascularization for treatment of multivessel coronary artery disease * The burden of cardiovascular disease and its impact on life expectancy in China
(Source: European Heart Journal)
Source: European Heart Journal - October 7, 2014 Category: Cardiology Tags: CardioPulse Source Type: research

Questioning the association between bisphosphonates and atypical femoral fractures
Bisphosphonates are the first‐line treatment for osteoporosis. Structurally, they are stable analogues of pyrophosphate and therefore exhibit a high affinity for bone mineral. They reduce bone loss by attenuating the ability of the osteoclast to resorb bone, decreasing activation frequency, and the rate of remodeling. Large prospective randomized placebo‐control trials provide unequivocal evidence for a reduction in the incidence of fractures. Impressively, 40 years since their first use in patients, the safety profile of bisphosphonates has been equally reassuring. Questions have arisen lately as to whether bisphospho...
Source: Annals of the New York Academy of Sciences - October 7, 2014 Category: Science Authors: Michael Pazianas, Se‐min Kim, Tony Yuen, Li Sun, Sol Epstein, Mone Zaidi Tags: Commentary Source Type: research

Overview of the 2014 food and drug administration cardiovascular and renal drugs advisory committee meeting about vorapaxar.
PMID: 25287768 [PubMed - in process] (Source: Circulation)
Source: Circulation - October 7, 2014 Category: Cardiology Authors: Baker NC, Lipinski MJ, Lhermusier T, Waksman R Tags: Circulation Source Type: research

Modeling and simulation for medical product development and evaluation: highlights from the FDA-C-Path-ISOP 2013 workshop
Abstract Medical-product development has become increasingly challenging and resource-intensive. In 2004, the Food and Drug Administration (FDA) described critical challenges facing medical-product development by establishing the critical path initiative [1]. Priorities identified included the need for improved modeling and simulation tools, further emphasized in FDA’s 2011 Strategic Plan for Regulatory Science [Appendix]. In an effort to support and advance model-informed medical-product development (MIMPD), the Critical Path Institute (C-Path) [www.c-path.org], FDA, and International Society of Pharmacometrics...
Source: Journal of Pharmacokinetics and Pharmacodynamics - October 7, 2014 Category: Drugs & Pharmacology Source Type: research

The concordance of HPV DNA detection by Hybrid Capture 2 and HPV on clinician- and self-collected specimens
Testing for high-risk human papillomavirus (HPV) is now being recommended for cervical cancer screening in both higher-resource settings [1] and lower-resource settings [2]. For the latter, careHPV™ (QIAGEN, Gaithersburg, MD, USA), a lower-cost, signal-amplification DNA test for a pool of 14 HPV types, was developed. careHPV is based on the same biochemistry as Hybrid Capture 2 (HC2; QIAGEN), a DNA test for a pool of 13 HPV types (the same as careHPV minus HPV66) that was U.S. Food and Drug Administration approved in 2003. (Source: Journal of Clinical Virology)
Source: Journal of Clinical Virology - October 7, 2014 Category: Virology Authors: Wen Chen, Jose Jeronimo, Fang-Hui Zhao, You-Lin Qiao, Melissa Valdez, Xun Zhang, Le-Ni Kang, Pooja Bansil, Proma Paul, Ping Bai, Roger Peck, Jing Li, Feng Chen, Mark H. Stoler, Philip E. Castle Source Type: research

Inferior Vena Cava Filter Embolus to the Right Ventricle: Anesthesia and High-Risk Percutaneous Procedures
INFERIOR VENA CAVA (IVC) filters are used to prevent pulmonary thromboembolism. They are used in patients who have a contraindication to anticoagulation, failure of anticoagulation, and as prophylaxis in patients with a high risk of developing venous thrombosis.1,2 In 2010, the United States Food and Drug Administration recommended that “implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection is no longer needed,” as the organization recognized the increasing reports of complications associated with filters. (Sourc...
Source: Journal of Cardiothoracic and Vascular Anesthesia - October 7, 2014 Category: Anesthesiology Authors: Raheel Bengali, Rafael Vazquez Tags: Case Reports Source Type: research

Late Cardiac Tamponade in Adults Secondary to Tip Position in the Right Atrium: An Urban Legend? A Systematic Review of the Literature
CENTRAL VENOUS CATHETER (CVC) placement is a very common procedure, considering that the Food and Drug Administration (FDA) has estimated that 5 to 6 million CVCs are placed annually in the United States. The FDA also receives reports that are useful in the identification of emerging problems associated with device use. More than a decade ago, one of these emerging problems was cardiac tamponade, a very rare but potentially fatal complication associated with CVC placement. Diagnosis of cardiac tamponade (CT) often is delayed, even when signs and symptoms are typical. (Source: Journal of Cardiothoracic and Vascular Anesthesia)
Source: Journal of Cardiothoracic and Vascular Anesthesia - October 7, 2014 Category: Anesthesiology Authors: Mauro Pittiruti, Massimo Lamperti Tags: Review ArticleGiovanni Landoni, MDSection Editors? > Source Type: research

HIV neuropathy
Purpose of review: To present an overview of HIV-associated distal symmetric polyneuropathy (HIV-DSP) and other HIV-related peripheral neuropathies in the post-highly active retroviral therapy era. Recent findings: HIV-DSP has become the most common neurologic complication of HIV largely due to the prolonged survival of HIV-positive patients with the advent of highly active retroviral therapy. HIV-DSP can be attributed to the disease itself or to secondary effects of certain HAART agents, and often the two disease entities cannot be distinguished. HIV-DSP can lead to significant morbidity and interfere with daily activitie...
Source: Current Opinion in HIV and AIDS - October 6, 2014 Category: Infectious Diseases Tags: HIV NEUROLOGY: Edited by Christopher Power and Bruce J. Brew Source Type: research

Specialty Pharmaceuticals: Policy Initiatives To Improve Assessment, Pricing, Prescription, And Use [Spending On Specialty Pharmaceuticals]
This article analyzes the five principal stages through which a specialty drug must pass on its journey from the laboratory to the bedside. These include regulatory approval by the Food and Drug Administration for market access, insurance coverage, pricing and payment, physician prescription, and patient engagement. If structured appropriately, each stage improves performance and supports continued research and development. If structured inappropriately, however, each stage adds to administrative burdens, distorts clinical decision making, and weakens incentives for innovation. Cautious optimism is in order, but neither th...
Source: Health Affairs - October 6, 2014 Category: Global & Universal Authors: Robinson, J. C., Howell, S. Tags: Access To Care, Ethical Issues, Health Promotion/Disease Prevention, Insurance Coverage, Legal/Regulatory Issues, Pharmaceuticals, Physicians, Public Health, Public Opinion, Quality Of Care, Health Spending, Politics Spending On Specialty Pharmaceutical Source Type: research

Despite High Costs, Specialty Drugs May Offer Value For Money Comparable To That Of Traditional Drugs [Spending On Specialty Pharmaceuticals]
Specialty drugs are often many times more expensive than traditional drugs, which raises questions of affordability and value. We compared the value of specialty and traditional drugs approved by the Food and Drug Administration (FDA) in the period 1999–2011. To do this, we identified published estimates of additional health gains (measured in quality-adjusted life-years, or QALYs) and increased costs of drug and health care resource use that were associated with fifty-eight specialty drugs and forty-four traditional drugs, compared to preexisting care. We found that specialty drugs offered greater QALY gains (0.183 ...
Source: Health Affairs - October 6, 2014 Category: Global & Universal Authors: Chambers, J. D., Thorat, T., Pyo, J., Chenoweth, M., Neumann, P. J. Tags: Access To Care, Health Care Finance, Health Promotion/Disease Prevention, Health Reform, Hospitals, Insurance Coverage, Legal/Regulatory Issues, Pharmaceuticals, Physicians, Chronic Care, Quality Of Care, Health Spending, Consumer Issues, Affordable Care Source Type: research