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Jiayu Zhang, Shifeng Wang, Lulu Xu, Qiao Zhang, Zhanpeng Shang, Yanling Zhang, Qinghua Wu, Shiyou Li, Yanjiang Qiao
ETHNOPHARMACOLOGICAL RELEVANCE: The complexity of ingredients in traditional Chinese medical formulas and the limited consideration of toxicological responses are fundamental issues that hamper prognostic information of drug quality control. MATERIALS AND METHODS: A multidisciplinary approach for quality control of Qingkailing injection (QKL) regarding drug induced liver toxicity was described for the first time. High content image analysis (HCA) was combined with reverse-phase chromatographic separation and high-resolution MS detection technologies to provide the dynamic responses of HepG2 cell injury...
December 5, 2017: Journal of Ethnopharmacology
Alexia Hermitte-Gandoliere, Nadine Petitpain, Marion Lepelley, Laure Thomas, Christine Le Beller, Jacqueline Ponte Astoul, Pierre Gillet
INTRODUCTION: Intravenous iron infusion may be complicated by extravasation and lead to cutaneous pigmentation. METHODS: We queried the French pharmacovigilance database to assess the spontaneously reported cases over the 2000-2016 period. RESULTS: Fifty-one cases of cutaneous pigmentation related to intravenous iron extravasation were retrieved, none was associated to necrosis. Most of patients were women aged 20 to 49 years old. The pigmentation was mostly a brown coloration, persisting over one month in 19 cases (37...
November 16, 2017: Thérapie
Paola Pansa, Yingfen Hsia, Julia Bielicki, Irja Lutsar, A Sarah Walker, Mike Sharland, Laura Folgori
BACKGROUND: There are very few options to treat multidrug-resistant bacterial infections in children. A major barrier is the duration and complexity of regulatory trials of new antibiotics. Extrapolation of safety data from adult trials could facilitate drug development for children. OBJECTIVE: We performed a systematic review on the safety of antibiotic clinical trials (CTs) in children (0-18 years) to evaluate the overall quality of safety trials conducted in children and to determine if age-specific adverse events (AEs) could be identified for specific antibiotic classes...
December 7, 2017: Drugs
Alan O Vázquez-Alvarez, Lorena Michele Brennan-Bourdon, Ana Rosa Rincón-Sánchez, María Cristina Islas-Carbajal, Selene G Huerta-Olvera
BACKGROUND: The aim of this study was to detect and analyze Adverse Drug Reactions (ADRs) through Intensive Pharmacovigilance (IPV) in hospitalized pediatric patients to improve drug safety. METHODS: A prospective 6-month cross-sectional study was performed in the pediatric service of a regional hospital in Mexico in order to assess hospitalized children from 1 day to 18 years old. The inclusion criteria were: both genders, all hospitalization causes, and at least one prescribed medication (indistinct drug group)...
December 8, 2017: BMC Pharmacology & Toxicology
Heather Y Yong, Kyla A McKay, Cole G J Daley, Helen Tremlett
BACKGROUND: Several environmental and lifestyle factors have been associated with multiple sclerosis (MS) risk, including some pharmacological treatments. We systematically reviewed the literature on prescription drug exposure and MS risk. METHODS: Six databases were searched for original observational studies reporting drug exposure and MS risk published before 2017. RESULTS: Thirteen articles fulfilled inclusion criteria. Exposure to neither amiloride nor valproic acid was associated with MS (adjusted hazard ratio (adj...
December 6, 2017: Pharmacoepidemiology and Drug Safety
Margareth Ndomondo-Sigonda, Jacqueline Miot, Shan Naidoo, Alexander Dodoo, Eliangiringa Kaale
Sound regulatory systems are critical for protecting public health against use of medical products which do not meet international standards of quality, safety and efficacy. This review provides a summary of the current status of National Medicines Regulatory Authorities (NMRAs) in Africa, and various initiatives that have been established to improve their performance. All countries in Africa (except Sahrawi Republic), have NMRAs but their organizational set-up and functionality is variable. Some are located within Ministries of Health and others are semi-autonomous...
2017: Pharmaceutical Medicine
Ushma Mehta, Emma Kalk, Andrew Boulle, Portia Nkambule, Joey Gouws, Helen Rees, Karen Cohen
South Africa has been engaged in pharmacovigilance (PV) activities to assess the impact of adverse drug reactions on public safety and health for 40 years. Activities have evolved from passive regulatory reporting to encompass active surveillance systems. The HIV and AIDS and TB epidemics stimulated pharmacoepidemiological research into the risks associated with medicines used in the standardised regimens of mass treatment programmes. Specific safety concerns, supported by robust local cohort data, have prompted major changes to national and international treatment policies...
2017: South African Health Review
Takashi Tomita
 Several issues concerning medicines remain unclear, including the availability of known, but not easily recognizable information. This review evaluates the mechanisms of side effects and the various risk indications included in package inserts. The results can be summarized as follows. 1) Short-term exposure to gatifloxacin significantly induced insulin secretion and increased the cytosolic Ca2+ concentration of islet cells by augmenting extracellular Ca2+ influx and its release from the endoplasmic reticulum...
2017: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
Maxime Bataillard, Marie-Noëlle Beyens, Geneviève Mounier, Delphine Vergnon-Miszczycha, Haleh Bagheri, Pascal Cathebras
BACKGROUND/AREA OF UNCERTAINTY: Statins, which reduce cardiovascular risk in both primary and secondary prevention, are one of the most widely prescribed therapeutic classes in the world. Usually well-tolerated, statin-associated muscle symptoms are a well-known adverse effect. Fusidic acid (FA) is a bacteriostatic antibiotic of interest in the treatment of methicillin-resistant Staphylococcus aureus infections. Cases of rhabdomyolysis, sometimes fatal, have been reported after coprescription of FA and a statin...
November 9, 2017: American Journal of Therapeutics
Mary Ann Chapman, David Charles, Arturo Loaiza-Bonilla
BACKGROUND: Biosimilars have the potential to create competition, lower costs, and increase patient access to biological medications. However, biological medications are sensitive to their manufacturing processes and difficult to precisely characterize, leading to questions about substitution and interchangeability among products. METHODS: This article reviews the role of biosimilars in patient access to therapeutic antibodies. RESULTS: Although pathways for the approval of biosimilars have been developed, important issues remain unresolved...
November 29, 2017: Current Pharmaceutical Design
Robert Carroll, Sreeram V Ramagopalan, Javier Cid-Ruzafa, Dimitra Lambrelli, Laura McDonald
BACKGROUND: The objective of this study was to investigate the study design characteristics of Post-Authorisation Studies (PAS) requested by the European Medicines Agency which were recorded on the European Union (EU) PAS Register held by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). METHODS: We undertook a cross-sectional descriptive analysis of all studies registered on the EU PAS Register as of 18 th October 2016. RESULTS: We identified a total of 314 studies on the EU PAS Register, including 81 (26%) finalised, 160 (51%) ongoing and 73 (23%) planned...
2017: F1000Research
Arne Homann, Niels Röckendorf, Arno Kromminga, Andreas Frey, Thomas A Platts-Mills, Uta Jappe
Biological drugs like therapeutic antibodies are widely used for the treatment of various diseases like inflammatory disorders and cancer. A drawback of these novel treatments is the substantial proportion of patients experiencing adverse reactions such as loss-of-drug effect or hypersensitivity reactions. These reactions are associated with pre-existing and/or developing anti-drug antibodies. Especially IgE development is a risk factor for life-threatening systemic anaphylaxis. METHODS: In order to characterize the individual drug-specific serum IgE, an IgE cross-reactivity immune profiling (ICRIP) assay was developed...
2017: Theranostics
O Esteban-Jiménez, C Navarro-Pemán, L Urieta-González
OBJECTIVE: To analyse the adverse drug reactions (ADRs) caused by Sodium-glucose Cotransporter-2 Inhibitors (SGLT2i) notified in Spain since they have been on the market. MATERIAL AND METHODS: An analysis was made of all the notifications registered in the Spanish Pharmacovigilance System of drugs for human use, arising from the use of SGLT2i. RESULTS: A total of 311 notifications were recorded, of which 169 (54.34%) were related to dapagliflozin, 81 (26...
November 25, 2017: Semergen
Silvio Garattini, Vittorio Bertele'
Consideration of drug benefits and harms is asymmetric. Approval of drugs is mainly based on efficacy, while the assessment of their safety is left to post-marketing commitments or spontaneous reporting. Benefits are overestimated as a result of pharmaceutical companies' advertisements, the paucity of independent information, and the scant understanding of the effectiveness of medicines in real life. Polypharmacy in older adults-even during the last period of their life-reflects the tendency to assign priority to efficacy and overlook harms, although nobody knows what happens when three or more drugs are given chronically...
November 27, 2017: European Journal of Clinical Pharmacology
Udo Bonnet, Norbert Scherbaum
In the last ten years, the prescriptions of the gabapentinoids gabapentin and pregabalin increased largely also in Germany. Since several national and international pharmacovigilance-databases have warned for abuse liabilities and overdose fatalities in association with both gabapentinoids, which moreover, became to be sold on internet and black-markets, their addictive power has been subject to an ongoing clinical debate. As pre- and post-approval clinical trials did not reveal significant signs of dependence on gabapentin or pregabalin, we systematically searched in PubMed and Scopus for clinical studies and case reports being associated with abuse of and dependence on these drugs...
November 27, 2017: Fortschritte der Neurologie-Psychiatrie
Jean-Luc Faillie
Case-non case studies belongs to the methods assessing drug safety by analyzing the disproportionality of notifications of adverse drug reactions in pharmacovigilance databases. Used for the first time in the 1980s, the last few decades have seen a significant increase in the use of this design. The principle of the case-non case study is to compare drug exposure in cases of a studied adverse reaction with that of cases of other reported adverse reactions and called "non cases". Results are presented in the form of a reporting odds ratio (ROR), the interpretation of which makes it possible to identify drug safety signals...
October 31, 2017: Thérapie
E Raschi, M Parisotto, E Forcesi, M La Placa, G Marchesini, F De Ponti, E Poluzzi
BACKGROUND AND AIMS: We assessed post-marketing safety of sodium-glucose co-transporter-2 inhibitors (SGLT2-Is) by analyzing adverse events (AEs) reported in international pharmacovigilance databases. METHODS AND RESULTS: Eudravigilance, WHO-Vigibase (as of Feb 25, 2017) and the FDA Adverse Event Reporting System (FAERS, from 2004 to 2016 second quarter) were queried to extract AEs recording SGLT2-Is as suspect. Disproportionality analyses (case/non-case method) were performed in FAERS by calculating the reporting odds ratios (RORs) from System Organ Classes (SOCs) to Preferred Terms (PTs) (precise clinical entities)...
October 18, 2017: Nutrition, Metabolism, and Cardiovascular Diseases: NMCD
Sreedhar Sagi, Hillel P Cohen, Gillian R Woollett
It is important that systems are in place to ensure that appropriate and comprehensive records are kept for use of all medications. It is fundamental to an effective pharmacovigilance system that patient medical records contain sufficient information to identify which medication has been prescribed, when it was administered, and at what dose. The availability of biologics from multiple sponsors has raised questions by some health care providers about the ability of current pharmacovigilance systems to trace specific biologics...
December 2017: Journal of Managed Care & Specialty Pharmacy
Jyoti Joshi, Manoja Kumar Das, Deepak Polpakara, Satinder Aneja, Mahesh Agarwal, Narendra Kumar Arora
Assured quality vaccines and safe immunization practices are pre-requisite to successful immunization programs. All vaccines go through stringent safety checks during pre-licensure stage. Adverse Events Following Immunization (AEFI) Surveillance program is an integral part of routine immunization program in India to monitor the vaccine safety in the post licensure phase. Indian AEFI Program: National AEFI surveillance relies on passive surveillance and reporting by the health functionaries and practitioners...
November 23, 2017: Indian Journal of Pediatrics
M Harry, D Lebel, A Comtois, J-F Bussières
INTRODUCTION: In view of the underdeclaration of adverse drug reactions (ADRs), there is a need for optimizing their reporting. To improve our declaration, a pharmacovigilance program was started in 2006 at our center and measures were progressively started (weekly patient rounds, monthly report, etc.). The objectives of the study were to describe and compare the annual average incidence of the ADRs coded by the medical archivists from 1 April 1989 to 31 March 2010 (period 1) and from 1 April 2010 to 31 March 2015 (period 2), to determine the therapeutic classes of drugs associated with ADRs according to age and determine the percentage of ADRs that are declared to Health Canada...
November 20, 2017: Archives de Pédiatrie: Organe Officiel de la Sociéte Française de Pédiatrie
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