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Cristina Solomon, Wolfgang Korte, Dietmar Fries, Inna Pendrak, Christine Joch, Albrecht Gröner, Ingvild Birschmann
BACKGROUND: Plasma-derived factor XIII (FXIII) concentrate is an effective treatment for FXIII deficiency. We describe adverse drug reactions (ADRs) reported during pharmacovigilance monitoring of Fibrogammin®/Corifact® and review published safety data. METHODS: Postmarketing safety reports recorded by CSL Behring from June 1993 to September 2013 were analyzed. Clinical studies published during the same period were also reviewed. RESULTS: Commercial data indicated that 1,653,450,333 IU FXIII concentrate were distributed over the review period, equivalent to 1,181,036 doses for a 70 kg patient...
September 2016: Transfusion Medicine and Hemotherapy
P Engel, M F Almas, M L De Bruin, K Starzyk, S Blackburn, N A Dreyer
AIM: To describe and characterise the first cohort of Post-Authorisation Safety Study (PASS) protocols reviewed under the recent European Pharmacovigilance Legislation. METHODS: A systematic approach was used to compile all publicly available information on PASS protocols and assessments submitted from July 2012 to July 2015 from Pharmacovigilance Risk Assessment Committee (PRAC) minutes, European Medicines Agency (EMA) and European Network of Pharmacovigilance and Pharmacoepidemiology (ENCePP) webpages...
October 25, 2016: British Journal of Clinical Pharmacology
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
Insa Joost, Johannes Steinfurt, Philipp T Meyer, Winfried V Kern, Siegbert Rieg
BACKGROUND: Ustekinumab (Stelara®), a human monoclonal antibody targeting the p40-subunit of interleukin (IL)-12 and IL-23, is indicated for moderate to severe plaque psoriasis and psoriatic arthritis. In large multicenter, prospective trials assessing efficacy and safety of ustekinumab increased rates of severe infections have not been observed so far. CASE PRESENTATION: Here, we report the case of a 64-year old woman presenting with chills, pain and swelling of her right foot with dark maculae at the sole, and elevated inflammatory markers...
October 20, 2016: BMC Infectious Diseases
J L NDiaye, B Cissé, E H Ba, J F Gomis, C T Ndour, J F Molez, F B Fall, C Sokhna, B Faye, E Kouevijdin, F K Niane, M Cairns, J F Trape, C Rogier, O Gaye, B M Greenwood, P J M Milligan
BACKGROUND: It is recommended that children aged 3 months to five years of age living in areas of seasonal transmission in the sub-Sahel should receive Seasonal Malaria Chemoprevention (SMC) with sulfadoxine-pyrimethamine plus amodiaquine (SPAQ) during the malaria transmission season. The purpose of this study was to evaluate the safety of SMC with SPAQ in children when delivered by community health workers in three districts in Senegal where SMC was introduced over three years, in children from 3 months of age to five years of age in the first year, then in children up to 10 years of age...
2016: PloS One
Jan-Willem Alffenaar, Onno W Akkerman, Richard Anthony, Simon Tiberi, Scott Heysell, M P Grobusch, Frank Cobelens, Dick van Soolingen
Success rates for treatment of extensively drug resistant tuberculosis (XDR-TB) are low due to limited treatment options, delayed diagnosis and inadequate health care infrastructure. Areas covered: This review analyses existing programmes of prevention, diagnosis and treatment of XDR-TB. Improved diagnostic procedures and rapid molecular tests help to select appropriate drugs and dosages. Drugs dosages can be further tailored to the specific conditions of the patient based on quantitative susceptibility testing of the M...
October 20, 2016: Expert Review of Anti-infective Therapy
(no author information available yet)
Pharmacovigilance is the science and activity relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. Pharmacovigilance basically targets safety of medicine. Pharmacists have crucial role in health systems to maintain the rational and safe use of medicine for they are drug experts who are specifically trained in this field. Effective use of pharmacists' workforce will improve the outcome of the pharmacotherapy as well as decrease global health costs...
2016: Online Journal of Public Health Informatics
Kingston Rajiah, Mari Kannan Maharajan, Shashina Nair
Pharmacy students' knowledge about adverse drug reaction reporting can impact their attitude towards patient care and issues on patient safety. The aim of this study was to investigate the knowledge and perception of pharmacy students about adverse drug reaction reporting and pharmacovigilance and to study their willingness to report. A cross-sectional study using a validated questionnaire was conducted among the university students. The demographic details of the respondents were studied. The number of female respondents was comparatively higher than the male respondents...
September 2016: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
Racha Fadlallah, Fadi El-Jardali, Farah Annan, Hayat Azzam, Elie A Akl
BACKGROUND: A recent systematic review suggested that drug registrations and onsite quality inspections may be effective in reducing the prevalence of counterfeit and substandard drugs. However, simply replicating the most effective interventions is problematic, as it denotes implementing the intervention without further adaptation. OBJECTIVE: The aim was to systematically review the evidence beyond effectiveness for systems-level interventions to combat or prevent drug counterfeiting...
2016: Pharmaceutical Medicine
Isabelle Récoché, Vanessa Rousseau, Robert Bourrel, Maryse Lapeyre-Mestre, Leila Chebane, Fabien Despas, Jean-Louis Montastruc, Emmanuelle Bondon-Guitton
Many patients treated with imatinib, used in cancer treatment, are using several other drugs that could interact with imatinib. Our aim was to study all the drug-drug interactions (DDIs) observed in patients treated with imatinib.We performed 2 observational studies, between the 1st January 2012 and the 31st August 2015 in the Midi-Pyrénées area (South Western France), using the French health insurance reimbursement database and then the French Pharmacovigilance Database (FPVD).A total of 544 patients received at least 1 reimbursement for imatinib...
October 2016: Medicine (Baltimore)
Osvaldo Marrero, Eric Y Hung, Manfred Hauben
BACKGROUND: Many illnesses demonstrate seasonal and geographic variations. Pharmacovigilance is unique among public health surveillance systems in terms of the clinical diversity of the events under surveillance. Since many pharmacovigilance signal detection methodologies are geared towards looking for increased frequency of spontaneous adverse drug event (ADE) reporting over variable time frames, seasonality of ADEs may have implications for signal detection. OBJECTIVE: The aim of this study was to investigate whether a set of illnesses that might be expected to display seasonality in general, did so when spontaneously reported as ADEs...
September 2016: Drugs—Real World Outcomes
Gulnihal Ozcan, Emel Aykac, Yelda Kasap, Nergiz T Nemutlu, Ebru Sen, N Demet Aydinkarahaliloglu
INTRODUCTION: In Turkey, pharmacovigilance began in 1985. A fully structured adverse drug reaction (ADR)-reporting system was established with the publication of the first pharmacovigilance regulation in 2005. Subsequent regulation published in 2014 brought further improvements to the system. OBJECTIVE: In this study, we aimed to analyse the ADR-reporting pattern in the context of the first pharmacovigilance legislation in Turkey. METHODS: We analysed ADR reports submitted to the Turkish Pharmacovigilance Center (TUFAM) from 2005 to 2014 with respect to reporting rate (RR), patient characteristics, type of the ADRs, suspected drugs, source of the report and the profession of the reporter...
March 2016: Drugs—Real World Outcomes
Magdalena M Watras, Jignesh P Patel, Roopen Arya
Hair loss is associated with the anticoagulants heparin and warfarin. With the recent availability of direct oral anticoagulants (DOACs) it is of clinical interest to know if they are implicated with hair loss and/or whether they could be successfully prescribed for patients who suffer from coumarin- or heparin-related alopecia. Initially reports of heparin- and coumarin-associated alopecia available through PubMed and Medline were explored in order to establish the cause of this side effect. Currently there is a lack of unanimity on why anticoagulants cause alopecia...
March 2016: Drugs—Real World Outcomes
Joachim Alexandre, Xavier Humbert, Marion Sassier, Paul Milliez, Antoine Coquerel, Sophie Fedrizzi
Cluster headache (CH) is a primary headache disorder with relatively effective treatments. Although few sufficiently controlled trials are available, verapamil is recommended as the first-line prophylactic drug for CH by the French Headache Society (with a low level of evidence, level B) and by the EFNS (European Federation of Neurological Societies, level A). Daily doses of more than 480 mg (and up to 1200 mg daily) are frequently used off-label, while 360 mg daily is the only dosage to have demonstrated its effectiveness in a double-blind trial against placebo, and the usual label posology used by cardiologists is 240 mg daily in hypertension...
December 2015: Drug Saf Case Rep
J-N Chatelet, M Auffret, S Combret, E Bondon-Guitton, M Lambert, S Gautier
INTRODUCTION: Several cases of hearing loss induced by hydroxychloroquine have been reported in the literature but the role of hydroxychloroquine still remains debated. CASE REPORT: We report the first case, to our knowledge, of hearing loss induced by hydroxychloroquine with a positive re challenge in a woman treated for systemic lupus. An analysis of the French pharmacovigilance database allowed to identify 23 additional cases of hearing loss in patients treated with hydroxychloroquine and, among them, 8 had systemic lupus...
October 13, 2016: La Revue de Médecine Interne
Choki Dorji, Pramote Tragulpiankit, Arthorn Riewpaiboon, Tashi Tobgay
INTRODUCTION: The Bhutan National Pharmacovigilance Centre (NPC) became an official member of the WHO Programme for International Drug Monitoring in December 2014; however, the number of adverse drug reactions (ADRs) reported is very low (50 reports per 773,722 inhabitants over 10 years). Surveys of healthcare professionals (HCPs) in similar countries have indicated that adequate knowledge of both ADRs and ADR reporting is likely to increase the number of ADR reports submitted. OBJECTIVE: The aim of this study was to investigate the level of knowledge of both ADRs and ADR reporting among HCPs, including traditional medicine practitioners...
October 14, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Jisha Myalil Lucca, Madhan Ramesh, Gurumurthy Parthasarathi, Dushad Ram
AIMS/OBJECTIVES: Psychotropic drugs are associated with significant short-term and long-term safety issues which may affect patients' mental health, physical health and cost of care. EXPERIMENTAL DESIGNS: This was a prospective study conducted in psychiatry department of a tertiary care hospital. Study included patients of any age and either sex who presented with psychiatric illness as diagnosed by ICD-10 and were receiving at least one psychotropic agent. The study involved both intensive and spontaneous reporting methods to identify ADRs...
March 1, 2016: Psychopharmacology Bulletin
Olivier Colin, Sylvie Favrelière, Alexandre Quillet, Jean-Philippe Neau, Jean-Luc Houeto, Claire Lafay-Chebassier, Marie-Christine Pérault-Pochat
Progressive multifocal leukoencephalopathy (PML) is an often fatal demyelinating disease of the central nervous system. As effective treatment is unavailable, identification of all drugs that could be associated with PML is essential. The objective of this study was to investigate the putative association of reports of PML and drugs. We used the case/noncase method in the French PharmacoVigilance Database (FPVD). Cases were reports of PML in the FPVD between January 2008 and December 2015. Noncases were all other reports during the same period...
October 13, 2016: Fundamental & Clinical Pharmacology
Amy Tanti, Benjamin Micallef, Anthony Serracino-Inglott, John-Joseph Borg
Regulatory authorities have a legal mandate to implement and maintain a Pharmacovigilance System designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance. Areas covered: This review maps the implementation of pharmacovigilance activities in Malta since accession in the EU in mid 2004 and discusses the challenges the Maltese Regulator encountered while setting up adequate and effective systems to fulfil its legal mandate. Areas reviewed are those around ADR reporting, promotion and safety communications including rapid alerts and recalls, direct healthcare professional communications, risk minimisation measures and safety circulars and quality systems...
October 12, 2016: Expert Opinion on Drug Safety
Steven Jarrett, Theodor Dingermann
BACKGROUND: Pharmacists are the recognized experts in pharmacotherapy. With the recent introduction of biosimilar agents into the US market, pharmacists are poised to play a pivotal role in evaluating their risks versus benefits within the framework of cost containment. PURPOSE: This article provides hospital pharmacists with the necessary information on the principles surrounding the development, approval process, and use of biosimilars. METHODS: Information contained in this article enables hospital pharmacists to identify concerns relating to biosimilars, implement educational components, and successfully evaluate biosimilars for the addition to the formulary...
November 2015: Hospital Pharmacy
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