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https://www.readbyqxmd.com/read/28328128/first-drug-to-treat-spinal-muscular-atrophy-gets-fda-approval-costly-injectable-shown-to-stall-debilitating-muscle-wasting-effects-of-rare-genetic-disorder
#1
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No abstract text is available yet for this article.
April 2017: American Journal of Medical Genetics. Part A
https://www.readbyqxmd.com/read/28327498/activity-of-sulfa-drugs-and-their-combinations-against-stationary-phase-b-burgdorferi-in-vitro
#2
Jie Feng, Shuo Zhang, Wanliang Shi, Ying Zhang
Lyme disease is a most common vector-borne disease in the US. Although the majority of Lyme patients can be cured with the standard two- to four-week antibiotic treatment, at least 10%-20% of patients continue to suffer from prolonged post-treatment Lyme disease syndrome (PTLDS). While the cause for this is unclear, one possibility is that persisting organisms are not killed by current Lyme antibiotics. In our previous studies, we screened an FDA drug library and an NCI compound library on B. burgdorferi and found some drug hits including sulfa drugs as having good activity against B...
March 22, 2017: Antibiotics
https://www.readbyqxmd.com/read/28327122/midodrine-as-adjunctive-support-for-treatment-of-refractory-hypotension-in-the-intensive-care-unit-a-multicenter-randomized-placebo-controlled-trial-the-midas-trial
#3
Matthew H Anstey, Bradley Wibrow, Tharusan Thevathasan, Brigit Roberts, Khushi Chhangani, Pauline Yeung Ng, Alexander Levine, Alan DiBiasio, Todd Sarge, Matthias Eikermann
BACKGROUND: Patients admitted to intensive care units (ICU) are often treated with intravenous (IV) vasopressors. Persistent hypotension and dependence on IV vasopressors in otherwise resuscitated patients lead to delay in discharge from ICU. Midodrine is an oral alpha-1 adrenergic agonist approved for treatment of symptomatic orthostatic hypotension. This trial aims to evaluate whether oral administration of midodrine is an effective adjunct to standard therapy to reduce the duration of IV vasopressor treatment, and allow earlier discharge from ICU and hospital...
March 21, 2017: BMC Anesthesiology
https://www.readbyqxmd.com/read/28326459/preparation-and-evaluation-of-plga-coated-capsaicin-magnetic-nanoparticles
#4
Mrudhula Baskaran, Padmamalini Baskaran, Navamoney Arulsamy, Baskaran Thyagarajan
PURPOSE: Drugs used in the treatment of diseases can cause several unwanted systemic side effects. A site-specific drug delivery system can eliminate such consequences by delivering drugs to certain target areas of the body where therapeutic effects are required. Here we present the preparation and evaluation of magnetic nanoparticles of capsaicin, the active ingredient in chili peppers, coated with poly-L-lactide co-glycolide (PLGA), a FDA-approved biodegradable bioavailable polymer...
March 21, 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28326432/harnessing-scientific-literature-reports-for-pharmacovigilance-prototype-software-analytical-tool-development-and-usability-testing
#5
Alfred Sorbello, Anna Ripple, Joseph Tonning, Monica Munoz, Rashedul Hasan, Thomas Ly, Henry Francis, Olivier Bodenreider
OBJECTIVES: We seek to develop a prototype software analytical tool to augment FDA regulatory reviewers' capacity to harness scientific literature reports in PubMed/MEDLINE for pharmacovigilance and adverse drug event (ADE) safety signal detection. We also aim to gather feedback through usability testing to assess design, performance, and user satisfaction with the tool. METHODS: A prototype, open source, web-based, software analytical tool generated statistical disproportionality data mining signal scores and dynamic visual analytics for ADE safety signal detection and management...
March 22, 2017: Applied Clinical Informatics
https://www.readbyqxmd.com/read/28325149/low-dose-naltrexone-in-the-treatment-of-fibromyalgia
#6
Samy K Metyas, Karen Yeter, John Solyman, Daniel Arkfeld
Fibromyalgia is a chronic pain disorder characterized by diffuse musculoskeletal pain, fatigue, sleep disturbance and cognitive impairment. A significant number of fibromyalgia patients do not respond adequately to the current drugs (pregabalin, milnacipran, duloxetine) approved for fibromyalgia treatment by the Food and Drug Administration (FDA). Thus, there is still a need for adjunctive therapies. Naltrexone is an opioid receptor antagonist used to treat alcohol and opioid dependence. It is hypothesized that low dose naltrexone causes transient blockade of opioid receptors centrally resulting in a rebound of endorphin function which may attenuate pain in fibromyalgia...
March 21, 2017: Current Rheumatology Reviews
https://www.readbyqxmd.com/read/28324933/an-ultrasonically-powered-implantable-device-for-targeted-drug-delivery
#7
Jayant Charthad, Spyridon Baltsavias, Devleena Samanta, Ting Chia Chang, Marcus J Weber, Niloufar Hosseini-Nassab, Richard N Zare, Amin Arbabian
A wirelessly powered implantable device is proposed for fully programmable and localized drug delivery. The implant is powered using an external ultrasonic transmitter and operates at <; 5% of the FDA diagnostic ultrasound intensity limit. Drug release is achieved through electrical stimulation of drug-loaded polypyrrole nanoparticles. A design methodology for the implant electronics is presented and experimentally demonstrated to be accurate in predicting the concentration of the released drug. To the best of our knowledge, this is the first ultrasonically powered implantable device platform for targeted drug delivery using electroresponsive polymers...
August 2016: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
https://www.readbyqxmd.com/read/28322541/supramolecular-hydrogels-fabricated-from-supramonomers-a-novel-wound-dressing-material
#8
Wenwen Xu, Qiao Song, Jiangfei Xu, Michael J Serpe, Xi Zhang
Daily repeated wound dressing changes will lead to additional trauma to newly formed tissue and prolonging the healing process. In this letter, we designed and fabricated an easy removable wound dressing material. To accomplish this, crosslinkable supramonomers were first generated through host-guest noncovalent interaction, followed by radical copolymerization of acrylamide with supramonomer as crosslinker to fabricate supramolecular hydrogels. Benefiting from the dynamic nature of the supramonomer, the supramolecular hydrogel is able to dissolve upon exposure to memantine, an FDA approved drug, making it easily removed from a wound, representing a promising candidate for the new generation of wound dressing...
March 21, 2017: ACS Applied Materials & Interfaces
https://www.readbyqxmd.com/read/28322140/applications-and-risks-of-nanomaterials-used-in-regenerative-medicine-delivery-systems-theranostics-and-therapy
#9
Estefany I Medina-Reyes, Danae Garcia-Viacobo, Franklin A Carrero-Martinez, Yolanda Irasema Chirino
Recent advances in nanotechnology have transformed the biomedicine field, in which the use of engineered nanomaterials (ENMs) has provided the foundation for novel applications. For this reason, the number of ENMs has increased rapidly, and here we provide a classification of ENMs based on chemical composition and biomedical applications, which include regenerative medicine, delivery systems, theranostics, and therapy. These have been identified as the most advanced and promising areas for further studies with humans...
2017: Critical Reviews in Therapeutic Drug Carrier Systems
https://www.readbyqxmd.com/read/28321144/summaries-of-safety-labeling-changes-approved-by-the-fda-boxed-warnings-highlights-october-december-2016
#10
Brenda J Rose
The FDA's MedWatch program safety labeling changes for boxed warnings are compiled quarterly for drugs and therapeutic biologics where important changes have been made to the safety information. Search of Drug Safety Labeling Changes (SLC) database was conducted on December 31, 2016 for date range "10/1/2016-12/31/2016", labeling section "Boxed Warning". These and other label changes are searchable in the Drug Safety Labeling Changes (SLC) database, where data are available to the public in downloadable and searchable formats...
February 2017: Hospital Pharmacy
https://www.readbyqxmd.com/read/28321135/ismp-adverse-drug-reactions
#11
Michael A Mancano
The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA's) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: mmancano@temple.edu). Your report will be published anonymously unless otherwise requested...
February 2017: Hospital Pharmacy
https://www.readbyqxmd.com/read/28319996/oral-direct-acting-agent-therapy-for-hepatitis-c-virus-infection-a-systematic-review
#12
Oluwaseun Falade-Nwulia, Catalina Suarez-Cuervo, David R Nelson, Michael W Fried, Jodi B Segal, Mark S Sulkowski
Background: Rapid improvements in hepatitis C virus (HCV) therapy have led to the approval of multiple oral direct-acting antiviral (DAA) regimens by the U.S. Food and Drug Administration (FDA) for treatment of chronic HCV infection. Purpose: To summarize published literature on the efficacy and safety of oral DAAs for treatment of persons with chronic HCV infection. Data Sources: MEDLINE and EMBASE from inception through 1 November 2016. Study Selection: 42 English-language studies from controlled and single-group registered clinical trials of adults with HCV infection that evaluated at least 8 weeks of an FDA-approved interferon-free HCV regimen that included at least 2 DAAs...
March 21, 2017: Annals of Internal Medicine
https://www.readbyqxmd.com/read/28319617/biosimilars-in-psoriasis-the-future-or-not
#13
Roselyn Kellen, Gary Goldenberg
As patents for the biologic agents reach their expiration dates, dermatologists must prepare for the coming of biosimilars. These agents have been deemed "highly similar" to their reference products in a process outlined by the US Food and Drug Administration (FDA). In 2016, the FDA approved 3 biosimilars for various indications including plaque psoriasis and psoriatic arthritis. However, biosimilars are not the same as small-molecule generics because they have a complex manufacturing process that makes it impossible to produce identical products to their reference products...
February 2017: Cutis; Cutaneous Medicine for the Practitioner
https://www.readbyqxmd.com/read/28318990/junctional-hemorrhage-control-for-tactical-combat-casualty-care
#14
REVIEW
Russ S Kotwal, Frank K Butler
During historic, as well as more recent, conflicts, most combat casualties who die from their injuries do so in the prehospital setting. Although many of the injuries incurred by these casualties are nonsurvivable, a number of injuries are still potentially survivable. Of those injuries that are potentially survivable, the majority are truncal, junctional, and extremity hemorrhage. Novel and effective approaches directed toward prehospital hemorrhage control have emerged in recent years, some of which can prove useful in the management of junctional hemorrhage whether in a military or civilian setting...
March 16, 2017: Wilderness & Environmental Medicine
https://www.readbyqxmd.com/read/28318897/efficacy-of-off-label-augmentation-in-unipolar-depression-a-systematic-review-of-the-evidence
#15
REVIEW
Julia Kleeblatt, Felix Betzler, Laura L Kilarski, Tom Bschor, Stephan Köhler
Treatment of unipolar depression with currently available antidepressants is still unsatisfactory. Augmentation with lithium or second generation antipsychotics is an established practice in non-responders to antidepressant monotherapy, but is also associated with a substantial non-response rate and with non-tolerance. Based on a systematic review of the literature, including meta-analyses, randomized controlled trials (RCTs), non-randomized comparative studies and case studies, off-label augmentation agents (administered in addition to an antidepressant, without FDA approval for treatment of MDD) were identified and evaluated regarding their efficacy using levels of evidence...
March 16, 2017: European Neuropsychopharmacology: the Journal of the European College of Neuropsychopharmacology
https://www.readbyqxmd.com/read/28317327/a-research-agenda-for-moving-early-medical-pregnancy-termination-over-the-counter
#16
REVIEW
Nathalie Kapp, Daniel Grossman, Emily Jackson, Laura Castleman, Dalia Brahmi
Given the overall safety profile and increasing availability of medical pregnancy termination drugs, we asked: would the mifepristone-misoprostol regimen for medical termination at ≤10 weeks gestation meet U.S. FDA regulatory criteria for over-the-counter (OTC) approval, and if not, what are the present research gaps? We conducted a literature review of consumer behaviors necessary for a successful OTC application for medical termination ≤10 weeks and identified crucial research gaps. If we were to embark on a development program for OTC or more generally, self-use of medical termination, the critical elements missing are the label comprehension, self -selection and actual use studies...
March 19, 2017: BJOG: An International Journal of Obstetrics and Gynaecology
https://www.readbyqxmd.com/read/28315798/bone-morphogenetic-proteins-in-anterior-cervical-fusion-a-systematic-review-and-meta-analysis
#17
REVIEW
Shayan Abdollah Zadegan, Aidin Abedi, Seyed Behnam Jazayeri, Hirbod Nasiri Bonaki, Seyed Behzad Jazayeri, Alexander R Vaccaro, Vafa Rahimi-Movaghar
OBJECTIVE: Bone morphogenetic proteins (BMPs) have been commonly used as a graft substitute in spinal fusion. Although the Food and Drug Administration (FDA) issued warning on life-threatening complications of recombinant human BMPs (rhBMPs) in cervical spine fusion in 2008, their off-label use has been continued. This investigation aimed to review the evidence for the use of rhBMP-2 and rhBMP-7 in anterior cervical spine fusions. METHODS: A comprehensive search was performed through Ovid (MEDLINE), PubMed and Embase...
March 15, 2017: World Neurosurgery
https://www.readbyqxmd.com/read/28315739/method-of-data-interpretation-for-the-determination-of-abuse-liability-in-rodent-self-administration-studies-under-the-fda-guidance-document
#18
David V Gauvin, Zachary J Zimmermann, Theodore J Baird
All new molecular entities that enter the CNS and exert an activity in the brain must be assessed for abuse liability prior to a New Drug Application approval by the US Food and Drug Administration. One element of the screening process is the assessment of the reinforcing properties of the drug candidate using the regulatory-preferred species, the rat. We describe one method of data review from the standard rat IV SA study design that can be used to conclude the relative abuse liability of the new drug entity...
March 15, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28315722/risk-mitigation-for-children-exposed-to-drugs-during-gestation-a-critical-role-for-animal-preclinical-behavioral-testing
#19
REVIEW
Irving Zucker
Many drugs with unknown safety profiles are administered to pregnant women, placing their offspring at risk. I assessed whether behavioral outcomes for children exposed during gestation to antidepressants, anxiolytics, anti-seizure, anti-nausea and sedative medications can be predicted by more extensive animal studies than are part of the FDA approval process. Human plus rodent data were available for only 8 of 33 CNS-active drugs examined. Similar behavioral and cognitive deficits, including autism and ADHD emerged in human offspring and in animal models of these disorders after exposure to fluoxetine, valproic acid, carbamazepine, phenytoin, phenobarbital, acetaminophen and ibuprofen...
March 15, 2017: Neuroscience and Biobehavioral Reviews
https://www.readbyqxmd.com/read/28315063/the-effect-of-regadenoson-on-the-integrity-of-the-human-blood-brain-barrier-a-pilot-study
#20
Sadhana Jackson, Richard T George, Martin A Lodge, Anna Piotrowski, Richard L Wahl, Sachin K Gujar, Stuart A Grossman
Regadenoson is an FDA approved adenosine receptor agonist which increases blood-brain barrier (BBB) permeability in rodents. Regadenoson is used clinically for pharmacologic cardiac stress testing using SPECT or CT imaging agents that do not cross an intact BBB. This study was conducted to determine if standard doses of regadenoson transiently disrupt the human BBB allowing higher concentrations of systemically administered imaging agents to enter the brain. Patients without known intracranial disease undergoing clinically indicated pharmacologic cardiac stress tests were eligible for this study...
March 17, 2017: Journal of Neuro-oncology
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