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FDA Problems

Ryan Eshleman, Rahul Singh
BACKGROUND: Adverse drug events (ADEs) constitute one of the leading causes of post-therapeutic death and their identification constitutes an important challenge of modern precision medicine. Unfortunately, the onset and effects of ADEs are often underreported complicating timely intervention. At over 500 million posts per day, Twitter is a commonly used social media platform. The ubiquity of day-to-day personal information exchange on Twitter makes it a promising target for data mining for ADE identification and intervention...
October 6, 2016: BMC Bioinformatics
Nitzan Soffer, Tamar Abuladze, Joelle Woolston, Manrong Li, Leigh Farris Hanna, Serena Heyse, Duane Charbonneau, Alexander Sulakvelidze
Contamination of pet food with Salmonella is a serious public health concern, and several disease outbreaks have recently occurred due to human exposure to Salmonella tainted pet food. The problem is especially challenging for raw pet foods (which include raw meats, seafood, fruits, and vegetables). These foods are becoming increasingly popular because of their nutritional qualities, but they are also more difficult to maintain Salmonella-free because they lack heat-treatment. Among various methods examined to improve the safety of pet foods (including raw pet food), one intriguing approach is to use bacteriophages to specifically kill Salmonella serotypes...
July 2016: Bacteriophage
Atsushi Kimishima, Cody J Wenthur, Lisa M Eubanks, Shun Sato, Kim D Janda
Although cocaine abuse and addiction continue to cause serious health and societal problems, an FDA-approved medication to treat cocaine addiction has yet to be developed. Employing a pharmacokinetic strategy, an anti-cocaine vaccine, provides an attractive avenue to address these issues, however, current vaccines have shown varying degrees of efficacy, indicating that further formulation is necessary. As a means to improve vaccine efficacy, we examined the effects of varying anti-cocaine vaccine formulations by combining a Toll-like receptor 9 (TLR9) agonist with a TLR5 agonist in the presence of alum...
October 7, 2016: Molecular Pharmaceutics
Sandra Petersen, Susan Houston, Huanying Qin, Corey Tague, Jill Studley
BACKGROUND: Behavioral problems may affect individuals with dementia, increasing the cost and burden of care. Pet therapy has been known to be emotionally beneficial for many years. Robotic pets have been shown to have similar positive effects without the negative aspects of traditional pets. Robotic pet therapy offers an alternative to traditional pet therapy. OBJECTIVE: The study rigorously assesses the effectiveness of the PARO robotic pet, an FDA approved biofeedback device, in treating dementia-related symptoms...
October 1, 2016: Journal of Alzheimer's Disease: JAD
Manoswini Chakrabarti, Ilika Ghosh, Aditi Jana, Manosij Ghosh, Anita Mukherjee
CONTEXT: Obesity is a major global health problem associated with various adverse effects. Pharmacological interventions are often necessary for the management of obesity. Orlistat is an FDA-approved antiobesity drug which is a potent inhibitor of intestinal lipases. OBJECTIVE: In the current study, orlistat was evaluated for its genotoxic potential in human lymphocyte cells in vitro and was compared with that of another antiobesity drug sibutramine, presently withdrawn from market due its undesirable health effects...
October 6, 2016: Drug and Chemical Toxicology
Maíra Teles Teixeira, Lívia Cristina Lira Sá-Barreto, Dayde Lane Mendonça Silva, Marcílio Sergio Soares Cunha-Filho
Tablet scoring is a controversial but common practice used to adjust doses, facilitate drug intake, or lower the cost of drug treatment, especially in children and the elderly. The risks of tablet scoring are mainly related to inaccuracies in the resulting dose and stability problems. The aim of this article is to provide an overview of worldwide guidelines regarding tablet scoring. We found that regulatory health agencies in Mercosur countries as well as other South American countries do not have published standards addressing tablet splitting...
June 2016: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
Abhay B Kadam, Karen Maigetter, Roger Jeffery, Nerges F Mistry, Mitchell G Weiss, Allyson M Pollock
BACKGROUND: Good drug regulation requires an effective system for monitoring and inspection of manufacturing and sales units. In India, despite widespread agreement on this principle, ongoing shortages of drug inspectors have been identified by national committees since 1975. The growth of India's pharmaceutical industry and its large export market makes the problem more acute. METHODS: The focus of this study is a case study of Maharashtra, which has 29% of India's manufacturing units and 38% of its medicines exports...
April 27, 2016: International Journal of Health Policy and Management
Vivian P Wagner, Marco A T Martins, Manoela D Martins, Kristy A Warner, Liana P Webber, Cristiane H Squarize, Jacques E Nör, Rogerio M Castilho
Patients with mucoepidermoid carcinoma (MEC) experience low survival rates and high morbidity following treatment, yet the intrinsic resistance of MEC cells to ionizing radiation (IR) and the mechanisms underlying acquired resistance remain unexplored. Herein, we demonstrated that low doses of IR intrinsically activated NFκB in resistant MEC cell lines. Moreover, resistance was significantly enhanced in IR-sensitive cell lines when NFκB pathway was stimulated. Pharmacological inhibition of the IKK-β/IκBα/NFκB axis, using a single dose of FDA-approved Emetine, led to a striking sensitization of MEC cells to IR and a reduction in cancer stem cells...
September 22, 2016: Oncotarget
Nassia Kioukia-Fougia, Nikolaos Georgiadis, Konstantinos Tsarouhas, Fotini Vasilaki, Persefoni Fragiadaki, Evangelia Meimeti, Christina Tsitsimpikou
BACKGROUND: The modern way of life involves high stress levels, poor eating habits, lack of exercise, obesity and other detrimental health factors. Nutritional supplements (NS) are complexes of nutrients with variant activity that may infer reversal to nutrient depletion. They tend to be popular amongst social categories associated with the healthy life style, such as the elite and amateur athletes, military people and the general population. OBJECTIVE: An overview of the state of play with regards to nutritional supplements -natural and synthetic-, is important both from toxicological and commercial point of view...
September 23, 2016: Recent Patents on Inflammation & Allergy Drug Discovery
Emily E Reichard, Nisha Nanaware-Kharade, Guillermo A Gonzalez, Shraddha Thakkar, S Michael Owens, Eric C Peterson
PURPOSE: Methamphetamine (METH) abuse is a worldwide drug problem, yet no FDA-approved pharmacological treatments are available for METH abuse. Therefore, we produced an anti-METH single chain antibody fragment (scFv7F9Cys) as a pharmacological treatment for METH abuse. ScFv's have a short half-life due to their small size, limiting their clinical use. Thus, we examined the pharmacokinetic effects of conjugating poly(ethylene) glycol (-PEG) to scFv7F9Cys to extend its functional half-life...
September 12, 2016: Pharmaceutical Research
Ana C Pinho, Ana C Fonseca, Arménio C Serra, José D Santos, Jorge F J Coelho
Experiments concerning peripheral nerve regeneration have been reported since the end of the 19(th) century. The need to implement an effective surgical procedure in terms of functional recovery has resulted in the appearance of several approaches to solve this problem. Nerve autograft was the first approach studied and is still considered the gold standard. Since autografts require donor harvesting, other strategies involving the use of natural materials have also been studied. Nevertheless, the results were not very encouraging and attention has moved towards the use of nerve conduits made from polymers, whose properties can be easily tailored and which allow the nerve conduit to be easily processed into a variety of shapes and forms...
September 7, 2016: Advanced Healthcare Materials
Yayoi Nomura, Yumi Sato, Ryoji Suno, Shoichiro Horita, So Iwata, Norimichi Nomura
Fv antibody fragments have been used as co-crystallization partners in structural biology, particularly in membrane protein crystallography. However, there are inherent technical issues associated with the large-scale production of soluble, functional Fv fragments through conventional methods in various expression systems. To circumvent these problems, we developed a new method, in which a single synthetic polyprotein consisting of a variable light (VL ) domain, an intervening removable affinity tag (iRAT), and a variable heavy (VH ) domain is expressed by a Gram-positive bacterial secretion system...
September 6, 2016: Protein Science: a Publication of the Protein Society
Niloy Bhattacharjee, Sujata Barma, Nandita Konwar, Saikat Dewanjee, Prasenjit Manna
Diabetic nephropathy (DN), a chronic complication of diabetes, is charecterized by glomerular hypertrophy, proteinuria, decreased glomerular filtration, and renal fibrosis resulting in the loss of renal function. Although the exact cause of DN remains unclear, several mechanisms have been postulated, such as hyperglycemia-induced renal hyper filtration and renal injury, AGEs-induced increased oxidative stress, activated PKC-induced increased production of cytokines, chemokines, and different inflammatory and apoptotic signals...
August 25, 2016: European Journal of Pharmacology
Loren Israelsen, Frank Lampe
The use of safe and beneficial dietary supplements remains an important part of your patients' healthy lifestyle-and supplements are likely an important part of your integrative medicine practice. Although issues surrounding potency, ingredient identification, adulteration, and the enforcement of existing laws are legitimate concerns for medical professionals and consumers, the responsible industry is actively working to raise quality standards for its products through a number of self-regulatory measures. These include education about and adoption of additional quality assurance initiatives, such as GMPs for botanical ingredients; better supply-chain management; adoption of improved identification and testing methodologies; an industry-wide product registry; the use of accredited third-party certifications and seals; and initiatives to promote widespread membership in the industry's trade associations, which is a reliable indicator of a company's support of and adherence to strict quality guidelines...
June 2016: Integrative Medicine
Paula R Trumbo
The US Food and Drug Administration (FDA) regulates the addition of iodine to infant formulas, the iodization of salt, and the addition of salt and iodine to foods. The required amount of iodine in infant formulas is based on caloric content, and the label must provide the iodine content per 100 kcal. Cuprous iodide and potassium iodide may be added to table salt as a source of dietary iodine at a maximum amount of 0.01%; if added, the label must indicate that the salt is iodized. Table salt to which iodine has not been added must bear the statement, "This salt does not supply iodide, a necessary nutrient...
September 2016: American Journal of Clinical Nutrition
Kristian P Doyle, Marion S Buckwalter
Post-stroke cognitive decline and dementia pose a significant public health problem, with 30% of stroke survivors suffering from dementia. The reason for this high prevalence is not well understood. Pathogenic B cell responses to the damaged CNS are one possible contributing factor. B-lymphocytes and antibodies are present in and around the stroke core of some human subjects who die with stroke and dementia, and mice that develop delayed cognitive dysfunction after stroke have clusters of B-lymphocytes in the stroke lesion, and antibody infiltration in the stroked hemisphere...
August 13, 2016: Brain, Behavior, and Immunity
Diana Isaacs, Lalita Prasad-Reddy, Sneha Baxi Srivastava
PURPOSE: Published data on the weight loss effects of glucagon-like peptide 1 (GLP-1) receptor agonists are reviewed, with a focus on data from clinical trials. SUMMARY: Obesity is a significant health problem in the United States (an estimated 69% of U.S. adults are overweight and nearly 35% are obese), and few drugs have proven safety and efficacy as adjuncts to lifestyle modification for weight management. GLP-1 receptor agonists are used for glycemic control in patients with type 2 diabetes and have been studied for their weight loss effects in patients with and without diabetes; these agents produce weight loss benefits through their effects on satiety and gastric emptying...
October 1, 2016: American Journal of Health-system Pharmacy: AJHP
Brad S Oriel, Kamal M F Itani
BACKGROUND: Surgical site infections (SSI) remain a significant problem to both the patients and the healthcare system. Value care and standardized quality measures continue to promote improvement in surgical asepsis, but certain debates remain unresolved in the field of surgical hand antisepsis. METHODS: Review of relevant accounts and literature. RESULTS: Controversy has existed regarding the U.S. Food and Drug Administration (FDA)'s 1994 Tentative Final Monograph (TFM), which defined how surgical hand antisepsis products are assessed...
August 10, 2016: Surgical Infections
Noemi Cowan, Alessia Raimondo, Jennifer Keiser
Infections with soil-transmitted helminths (STHs) are considered among the most persistent global health problems. The few available drugs have limitations including low efficacy against Trichuris trichiura infections. As a starting point toward drug repositioning, we studied a set of FDA-approved oncology drugs for activity against Trichuris muris since targets relevant to cancer therapy might have a function in helminth biology. Drugs were tested in vitro on the larval and adult stage of T. muris. Compounds active in vitro were tested in the T...
November 2016: Parasitology Research
Elizabeth A Nelson, Alyson B Barnes, Ronald D Wiehle, Gregory K Fontenot, Thomas Hoenen, Judith M White
The 2014 outbreak of Ebola virus (EBOV) in Western Africa highlighted the need for anti-EBOV therapeutics. Clomiphene is a U.S. Food and Drug Administration (FDA)-approved drug that blocks EBOV entry and infection in cells and significantly protects EBOV-challenged mice. As provided, clomiphene is, approximately, a 60:40 mixture of two stereoisomers, enclomiphene and zuclomiphene. The pharmacokinetic properties of the two isomers vary, but both accumulate in the eye and male reproductive tract, tissues in which EBOV can persist...
2016: Viruses
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