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FDA Problems

Matteo Ferrando, Francesca Racca, Lorena Nascimento Girardi Madeira, Enrico Heffler, Giovanni Passalacqua, Francesca Puggioni, Niccolò Stomeo, Giorgio Walter Canonica
Abstract: Allergen immunotherapy (AIT) is the only disease-modifying treatment approved for allergic rhinitis and allergic asthma and represents a suitable therapeutic option, especially in childhood, to modify the progression of respiratory allergic diseases. Starting from the previous "generic class effect" evaluation, as testified by the numerous meta analyses, AIT is now considered a product-specific pathogenic-oriented treatment. Background: AIT was empirically proposed more than one century ago in the subcutaneous form (SCIT), but the IgE-mediated mechanism of allergy was elucidated only after 50 years of clinical use of the treatment...
2018: Clinical and Molecular Allergy: CMA
Neil Blumberg, Jill M Cholette, Anthony P Pietropaoli, Richard Phipps, Sherry L Spinelli, Michael P Eaton, Suzie A Noronha, Jerard Seghatchian, Joanna M Heal, Majed A Refaai
Crystalloid infusion is widely employed in patient care for volume replacement and resuscitation. In the United States the crystalloid of choice is often normal saline. Surgeons and anesthesiologists have long preferred buffered solutions such as Ringer's Lactate and Plasma-Lyte A. Normal saline is the solution most widely employed in medical and pediatric care, as well as in hematology and transfusion medicine. However, there is growing concern that normal saline is more toxic than balanced, buffered crystalloids such as Plasma-Lyte and Lactated Ringer's...
February 21, 2018: Transfusion and Apheresis Science
Bryan D Loy, Michelle H Cameron, Patrick J O'Connor
Persistent fatigue is a common problem (∼20-45% of U.S. population), with higher prevalence and severity in people with medical conditions such as cancer, depression, fibromyalgia, heart failure, sleep apnea and multiple sclerosis. There are few FDA-approved treatments for fatigue and great disagreement on how to measure fatigue, with over 250 instruments used in research. Many instruments define fatigue as "a lack of energy", thus viewing energy and fatigue states as opposites on a single bipolar continuum...
April 2018: Medical Hypotheses
Paulina Paluchowska, Pawel Nowak, Malgorzata Skalkowska, Alicja Bjdak
Acinetobacter baumannii is a major cause of nosocomial infections worldwide. Therapeutic options in management of this bacteria are limited. Tigecycline is considered as an alternative treatment of infections caused by multidrug-resistant A. baumannii strains, however this resistance has emerged recently. Another growing problem is a lack of international consensus between U.S. FDA and EUCAST recommendations, regarding tigecycline breakpoints for Acinetobacter spp., and frequently off-label use. The aim of the present study was to assess the in vitm susceptibility to tigecycline and other antimicrobials, routinely used in the treatment of infections, among 155 A...
May 2017: Acta Poloniae Pharmaceutica
Kiel Hards, Gregory M Cook
From the war on drug resistance, through cancer biology, even to agricultural and environmental protection: there is a huge demand for rapid and effective solutions to control infections and diseases. The development of small molecule inhibitors was once an accepted "one-size fits all" approach to these varied problems, but persistence and resistance threaten to return society to a pre-antibiotic era. Only five essential cellular targets in bacteria have been developed for the majority of our clinically-relevant antibiotics...
January 2018: Drug Resistance Updates: Reviews and Commentaries in Antimicrobial and Anticancer Chemotherapy
Nicki Niemann, Joseph Jankovic
Tardive dyskinesia (TD) encompasses the spectrum of iatrogenic hyperkinetic movement disorders following exposure to dopamine receptor-blocking agents (DRBAs). Despite the advent of atypical or second- and third-generation antipsychotics with a presumably lower risk of complications, TD remains a persistent and challenging problem. Prevention is the first step in mitigating the risk of TD, but early recognition, gradual withdrawal of offending medications, and appropriate treatment are also critical. As TD is often a persistent and troublesome disorder, specific antidyskinetic therapies are often needed for symptomatic relief...
February 26, 2018: Drugs
Yuchen Wang, Maureen R Newman, Danielle S W Benoit
Impaired fracture healing is a major clinical problem that can lead to patient disability, prolonged hospitalization, and significant financial burden. Although the majority of fractures heal using standard clinical practices, approximately 10% suffer from delayed unions or non-unions. A wide range of factors contribute to the risk for nonunions including internal factors, such as patient age, gender, and comorbidities, and external factors, such as the location and extent of injury. Current clinical approaches to treat nonunions include bone grafts and low-intensity pulsed ultrasound (LIPUS), which realizes clinical success only to select patients due to limitations including donor morbidities (grafts) and necessity of fracture reduction (LIPUS), respectively...
February 19, 2018: European Journal of Pharmaceutics and Biopharmaceutics
Hany E Marei, A Hasan, R Rizzi, A Althani, N Afifi, C Cenciarelli, Thomas Caceci, Ashfaq Shuaib
Ischemic stroke is one of the major health problems worldwide. The only FDA approved anti-thrombotic drug for acute ischemic stroke is the tissue plasminogen activator. Several studies have been devoted to assessing the therapeutic potential of different types of stem cells such as neural stem cells (NSCs), mesenchymal stem cells, embryonic stem cells, and human induced pluripotent stem cell-derived NSCs as treatments for ischemic stroke. The results of these studies are intriguing but many of them have presented conflicting results...
2018: Frontiers in Neurology
Christopher Kalhagen Bjerkvig, Theodor Fosse, Torunn Oveland Apelseth, Joar Sivertsen, Hanne Braathen, Håkon Skogrand Eliassen, Anne Berit Guttormsen, Andrew P Cap, Geir Strandenes
BACKGROUND: Intraosseous (IO) vascular access is increasingly used as an emergency tool for achieving access to the systemic circulation in critically ill patients. The role of IO transfusion of blood in Damage Control Resuscitation is however questionable due to possible inadequate flow rate and hemolysis. Some experts claim that IO transfusion is contraindicated. In this study we have challenged this statement by looking at flow rates of autologous fresh whole blood reinfusion and hemolysis using two of the commonly used FDA-approved and CE-marked sternal needles...
February 17, 2018: Journal of Trauma and Acute Care Surgery
Y Wang, J Li
Corneal refractive surgery, as one of the common visual correction methods, has been increasingly accepted in China. There are a large number of people in China who undergo the corneal refractive surgery due to the high incidence of myopia in the country. It is essential that the safest and most effective surgery should be used to correct refractive errors in the cases involved with relatively normal eyes and corneas. In recent years, corneal refractive surgery has been rapidly developing with new technologies and techniques emerging all the time, such as SMILE (small incision lenticule extraction) surgery, which has been extensively applied in China since five years ago when it was approved by FDA...
January 11, 2018: [Zhonghua Yan Ke za Zhi] Chinese Journal of Ophthalmology
Piotr Rychahou, Younsoo Bae, Derek Reichel, Yekaterina Y Zaytseva, Eun Y Lee, Dana Napier, Heidi L Weiss, Nick Roller, Heather Frohman, Anh-Thu Le, B Mark Evers
Colorectal cancer (CRC) is the second leading cause of cancer deaths in the United States; the predominant cause for mortality is metastasis to distant organs (e.g., lung). A major problem limiting the success of chemotherapy in metastatic CRC is the inability to target tumor tissues selectively and avoid severe side effects to normal tissues and organs. Here, we demonstrate polymeric nanoparticles (PNPs) entrapping chemotherapeutic agents provide a new therapeutic option for treating CRC that has metastasized to the lung...
February 5, 2018: Journal of Controlled Release: Official Journal of the Controlled Release Society
Emily K Stern, Darren M Brenner
Opioid-induced constipation (OIC) is an increasingly prevalent problem in the USA due to the growing use of opioids. A novel class of therapeutics, the peripherally acting μ-opioid receptor antagonists (PAMORAs), has been developed to mitigate the deleterious effects of opioids in the gastrointestinal tract while maintaining central analgesia and minimizing opioid withdrawal. This review aimed to summarize the literature on naldemedine, the third PAMORA to gain US Food and Drug Administration (FDA) approval for the treatment of OIC in adults with chronic noncancer pain-related syndromes...
2018: Journal of Pain Research
Judy Nee, Mohammed Zakari, Michael A Sugarman, Julia Whelan, William Hirsch, Shahnaz Sultan, Sarah Ballou, Johanna Iturrino, Anthony Lembo
BACKGROUND & AIMS: Opioid induced constipation (OIC) is a common problem in patients on chronic opioid therapy for cancer-related and non-cancer related pain. Approved treatments for OIC are methylnaltrexone, naloxone, naloxegol, alvimopan, naldemedine, and lubiprostone. Since a meta-analysis performed in 2014, 2 new agents have been approved by the Food and Drug Administration (FDA) for treatment of OIC (naloxegol and naldemedine). METHODS: We conducted a search of the medical literature following the protocol outlined in the Cochrane Handbook for systematic review...
January 25, 2018: Clinical Gastroenterology and Hepatology
Michael E Hyland, Joseph W Lanario, Jill Pooler, Matthew Masoli, Rupert C Jones
BACKGROUND: Previous research shows that existing asthma quality of life questionnaires fail to measure the burden of oral corticosteroids that can be used to treat severe asthma, and are therefore not fit for purpose for severe asthma according to the USA's Federal Drug Authority's (FDA) criteria for content validity. Patient input and documentation of that input is key to achieving content validity according to FDA guidelines. This paper describes the process of constructing a new questionnaire to measure the burden of asthma symptoms and burden of treatment in severe asthma, using criteria specified by the FDA...
January 27, 2018: Health and Quality of Life Outcomes
Janelle D Vaughns, Laurie S Conklin, Ying Long, Panli Zheng, Fahim Faruque, Dionna J Green, John N van den Anker, Gilbert J Burckart
There is a lack of dosing guidelines for use in obese children. Moreover, the impact of obesity on drug safety and clinical outcomes is poorly defined. The paucity of information needed for the safe and effective use of drugs in obese patients remains a problem, even after drug approval. To assess the current incorporation of obesity as a covariate in pediatric drug development, the pediatric medical and clinical pharmacology reviews under the Food and Drug Administration (FDA) Amendments Act of 2007 and the FDA Safety and Innovation Act (FDASIA) of 2012 were reviewed for obesity studies...
January 19, 2018: Journal of Clinical Pharmacology
Fahima Dilnawaz, Sarbari Acharya, Sanjeeb Kumar Sahoo
Nanotechnology has become the indispensable cutting edge science providing solutions to many problems associated with human being. The application of nanotechnology associated to human health "nanomedicine" has revolutionized the drug delivery system by providing improved pharmacological and therapeutic properties of drugs. These advantageous effects of drug loaded nanocarrier systems are embraced by the pharmaceutical industries for the development of different effective nanocarriers. Currently, several drug loaded nanoformulations are approved by the Food and Drug Administration (FDA), and some of them are undergoing clinical trials for the human use...
January 12, 2018: International Journal of Pharmaceutics
Atsushi Kimishima, Margaret E Olson, Kim D Janda
Although cocaine addiction remains a serious health and societal problem in the United States, no FDA-approved treatment has been developed. Vaccines offer an exciting strategy for the treatment of cocaine addiction; however, vaccine formulations need to be optimized to improve efficacy. Herein, we examine the effectiveness of a tricomponent cocaine vaccine, defined as having its hapten (GNE) and adjuvant (cytosine-guanine oligodeoxynucleotide 1826, CpG ODN 1826) covalently linked via the immunogenic protein ovalbumin (OVA)...
December 20, 2017: Bioorganic & Medicinal Chemistry Letters
Dae-Wook Kang, Zehra Esra Ilhan, Nancy G Isern, David W Hoyt, Daniel P Howsmon, Michael Shaffer, Catherine A Lozupone, Juergen Hahn, James B Adams, Rosa Krajmalnik-Brown
Evidence supporting that gut problems are linked to ASD symptoms has been accumulating both in humans and animal models of ASD. Gut microbes and their metabolites may be linked not only to GI problems but also to ASD behavior symptoms. Despite this high interest, most previous studies have looked mainly at microbial structure, and studies on fecal metabolites are rare in the context of ASD. Thus, we aimed to detect fecal metabolites that may be present at significantly different concentrations between 21 children with ASD and 23 neurotypical children and to investigate its possible link to human gut microbiome...
December 21, 2017: Anaerobe
Jack E Henningfield, Reginald V Fant, Daniel W Wang
RATIONALE: Consideration by the US Drug Enforcement Administration and Food and Drug Administration of placing kratom into Schedule I of the Controlled Substances Act (CSA) requires its evaluation of abuse potential in the context of public health. OBJECTIVE: The objective of the study is to provide a review of kratom abuse potential and its evaluation according to the 8 factors of the CSA. RESULTS: Kratom leaves and extracts have been used for centuries in Southeast Asia and elsewhere to manage pain and other disorders and, by mid-twentieth century, to manage opioid withdrawal...
December 23, 2017: Psychopharmacology
Maricel V Maffini, Thomas G Neltner, Sarah Vogel
The American diet has changed dramatically since 1958, when Congress gave the United States Food and Drug Administration (FDA) the authority to ensure the safety of chemicals in food. Since then, thousands of chemicals have entered the food system. Yet their long-term, chronic effects have been woefully understudied, their health risks inadequately assessed. The FDA has been sluggish in considering scientific knowledge about the impact of exposures-particularly at low levels and during susceptible developmental stages...
December 2017: PLoS Biology
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