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Drug Safety: An International Journal of Medical Toxicology and Drug Experience

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https://www.readbyqxmd.com/read/28342075/evaluation-of-pre-marketing-factors-to-predict-post-marketing-boxed-warnings-and-safety-withdrawals
#1
Andreas Schick, Kathleen L Miller, Michael Lanthier, Gerald Dal Pan, Clark Nardinelli
INTRODUCTION: An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions...
March 24, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28342074/evaluation-of-saefvic-a-pharmacovigilance-surveillance-scheme-for-the-spontaneous-reporting-of-adverse-events-following-immunisation-in-victoria-australia
#2
Hazel J Clothier, Nigel W Crawford, Melissa Russell, Heath Kelly, Jim P Buttery
INTRODUCTION: Australia is traditionally an early adopter of vaccines, therefore comprehensive and effective post-licensure vaccine pharmacovigilance is critical to maintain confidence in immunisation, both nationally and internationally. With adverse event following immunisation (AEFI) surveillance the responsibility of Australian jurisdictions, Victoria operates an enhanced passive AEFI surveillance system integrated with clinical services, called 'SAEFVIC' (Surveillance of Adverse Events Following Vaccination In the Community)...
March 24, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28321782/targeting-interleukin-5-or-interleukin-5r%C3%AE-safety-considerations
#3
REVIEW
Diego Bagnasco, Matteo Ferrando, Marco Caminati, Alice Bragantini, Francesca Puggioni, Gilda Varricchi, Giovanni Passalacqua, Giorgio Walter Canonica
Asthma is a highly prevalent chronic disease of the airways; approximately 10% of patients with asthma will experience a severe form of the disease. New understanding of the pathogenesis of asthma has enabled the development of novel drugs and provided hope for patients with asthma. Interleukin (IL)-5 and IL-5 receptor subunit α (IL-5-Rα) plays a crucial role in the development, maturation, and operation of eosinophils so were the first important therapeutic target of these new drugs. While the results of early clinical trials of these drugs were not promising, results improved once researchers discovered the drugs worked best in patients with high eosinophil levels...
March 20, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28315139/medicines-save-medicines-kill
#4
LETTER
Joel Lexchin
No abstract text is available yet for this article.
March 17, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28299611/summarising-the-evidence-for-drug-safety-a-methodological-discussion-of-different-meta-analysis-approaches
#5
Guillermo Prada-Ramallal, Bahi Takkouche, Adolfo Figueiras
Evidence on drug safety obtained from randomised clinical trials is very limited due to, among other reasons, their relatively small sample size. Hence, combining the results of available studies can prove particularly useful. This paper reviews the different data sources for summarising drug safety outcomes, according to study design, publication of data, and origin of the information. It then discusses the various types of overviews that can be used in the study of treatment harms, focusing on meta-analyses of aggregate data and meta-analyses of individual patient data, with their advantages and drawbacks, such as publication bias and heterogeneity...
March 15, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28299610/pharmacovigilance-of-regenerative-medicine-under-the-amended-pharmaceutical-affairs-act-in-japan
#6
Yasuko Inokuma
Two Japanese regulatory agencies, the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency announced the implementation of a new review system called 'Conditional Approval,' specifically for the emerging field of regenerative medicine, in an amendment to the Pharmaceutical Affairs Act in 2014. Regenerative medicine was regulated in the category of 'Medical Devices' prior to the amendment and was not covered by the Relief Service, a system that provides financial aid to people who have experienced an adverse drug reaction and developed serious side effects as a result...
March 15, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28293864/using-probabilistic-record-linkage-of-structured-and-unstructured-data-to-identify-duplicate-cases-in-spontaneous-adverse-event-reporting-systems
#7
Kory Kreimeyer, David Menschik, Scott Winiecki, Wendy Paul, Faith Barash, Emily Jane Woo, Meghna Alimchandani, Deepa Arya, Craig Zinderman, Richard Forshee, Taxiarchis Botsis
INTRODUCTION: Duplicate case reports in spontaneous adverse event reporting systems pose a challenge for medical reviewers to efficiently perform individual and aggregate safety analyses. Duplicate cases can bias data mining by generating spurious signals of disproportional reporting of product-adverse event pairs. OBJECTIVE: We have developed a probabilistic record linkage algorithm for identifying duplicate cases in the US Vaccine Adverse Event Reporting System (VAERS) and the US Food and Drug Administration Adverse Event Reporting System (FAERS)...
March 14, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28275963/adverse-drug-event-causality-analysis-adeca-a-process-for-evaluating-evidence-and-assigning-drugs-to-risk-categories-for-sudden-death
#8
Raymond L Woosley, Klaus Romero, Craig W Heise, Tyler Gallo, Jared Tate, Raymond David Woosley, Sophie Ward
Growing evidence indicates that many drugs have the ability to cause a potentially lethal cardiac arrhythmia, torsades de pointes (TdP). This necessitates the development of a compilation of drugs that have this potential toxicity. Such a list is helpful in identifying the etiology of TdP in patients taking multiple drugs and assists decision making by those caring for patients at high risk of TdP. The Arizona Center for Education and Research on Therapeutics (AZCERT) has developed a process to standardize the identification of drugs and place them in risk categories for their clinical ability to cause TdP and QT prolongation...
March 8, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28247280/causality-assessment-in-pharmacovigilance-still-a-challenge
#9
I Ralph Edwards
Causality in pharmacovigilance is a difficult and time consuming exercise. This paper presents the challenges in determining causation by drug therapy. The first is that causation is complex and needs to be viewed from the context of the patient treated, rather than the drug product. Multiple causal vectors should be considered if we are to tackle the many issues involved in, for example, medication error and the many other factors that lead to bad outcomes from therapy, including failure to recognise known risk factors...
February 28, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28247279/patient-and-physician-perceptions-of-drug-safety-information-for-sleep-aids-a-qualitative-study
#10
Aaron S Kesselheim, Sarah A McGraw, Sara Z Dejene, Paula Rausch, Gerald J Dal Pan, Brian M Lappin, Esther H Zhou, Jerry Avorn, Eric G Campbell
INTRODUCTION: The US Food and Drug Administration uses drug safety communications (DSCs) to release emerging information regarding post-market safety issues, but it is unclear the extent of awareness by patients and providers of these communications and their specific recommendations. OBJECTIVE: We conducted semi-structured interviews with patients and physicians to evaluate their awareness and understanding of emerging drug safety information related to two sleep aids: zolpidem or eszopiclone...
February 28, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28247278/a-survey-on-pharmacovigilance-activities-in-asean-and-selected-non-asean-countries-and-the-use-of-quantitative-signal-detection-algorithms
#11
Cheng Leng Chan, Pei San Ang, Shu Chuen Li
INTRODUCTION: Most Countries have pharmacovigilance (PV) systems in place to monitor the safe use of health products. The process involves the detection and assessment of safety issues from various sources of information, communicating the risk to stakeholders and taking other relevant risk minimization measures. OBJECTIVES: This study aimed to assess the PV status in Association of Southeast Asian Nation (ASEAN) countries, sources for postmarket safety monitoring, methods used for signal detection and the need for a quantitative signal detection algorithm (QSDA)...
February 28, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28238125/post-marketing-regulation-of-medicines-withdrawn-from-the-market-because-of-drug-attributed-deaths-an-analysis-of-justification
#12
Igho J Onakpoya, Carl J Heneghan, Jeffrey K Aronson
INTRODUCTION: Several medicinal products have been withdrawn from the market because of drug-attributed deaths. However, there has been no investigation of whether such withdrawals were justified, and the extent to which confirmatory studies are used to investigate drug-adverse event relationships when deaths are reported is uncertain. We documented medicinal products withdrawn from the market because of drug-attributed deaths, identified confirmatory studies investigating the drug-adverse event relationships, examined whether withdrawals of medicinal products because of drug-attributed deaths after marketing were justified based on a mechanistic analysis, and examined the trends over time...
February 25, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28205099/evaluation-of-potentially-drug-related-patient-reported-common-symptoms-assessed-during-clinical-medication-reviews-a-cross-sectional-observational-study
#13
Tim W A Schoenmakers, Martina Teichert, Michel Wensing, Peter A G M de Smet
INTRODUCTION: Healthcare professionals tend to consider common non-alarming drug-related symptoms to be of little clinical relevance. However, such symptoms can have a substantial impact on the individual patient. Insight into patient-reported symptoms could aid pharmacists to identify improvements in medication treatment, for instance in the patient interview at the start of a clinical medication review (CMR). OBJECTIVE: The objectives of this study were to describe the numbers and types of patient-reported symptoms assessed during a CMR and to elucidate their potential association with the drugs in use...
February 15, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28194654/the-risk-of-ischemic-cardio-and-cerebrovascular-events-associated-with-oxycodone-naloxone-and-other-extended-release-high-potency-opioids-a-nested-case-control-study
#14
Kathrin Jobski, Bianca Kollhorst, Edeltraut Garbe, Tania Schink
INTRODUCTION: In Germany, an extended-release (ER) combination of the high-potency opioid (HPO) oxycodone and the antagonist naloxone was approved in 2006. In recent years, the cardio- and cerebrovascular safety of opioid antagonists and of opioids themselves has been discussed. OBJECTIVES: The objective of this study was to estimate the risk of major ischemic cardio- and cerebrovascular events in patients receiving ER oxycodone-naloxone compared with those receiving other ER HPOs...
February 13, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28188601/sensitivity-of-the-uk-clinical-practice-research-datalink-to-detect-neurodevelopmental-effects-of-medicine-exposure-in-utero-comparative-analysis-of-an-antiepileptic-drug-exposed-cohort
#15
R A Charlton, A McGrogan, J Snowball, L M Yates, A Wood, J Clayton-Smith, W H Smithson, J L Richardson, N McHugh, S H L Thomas, G A Baker, R Bromley
INTRODUCTION: Electronic healthcare data have several advantages over prospective observational studies, but the sensitivity of data on neurodevelopmental outcomes and its comparability with data generated through other methodologies is unknown. OBJECTIVES: The objectives of this study were to determine whether data from the UK Clinical Practice Research Datalink (CPRD) produces similar risk estimates to a prospective cohort study in relation to the risk of neurodevelopmental disorders (NDDs) following prenatal antiepileptic drug (AED) exposure...
February 10, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28188600/authors-reply-to-alain-braillon-s-comment-on-proactive-regional-pharmacovigilance-system-versus-national-spontaneous-reporting-for-collecting-safety-data-on-concerning-off-label-prescribing-practices-an-example-with-baclofen-and-alcohol-dependence-in-france
#16
LETTER
Marine Auffret, Julien Labreuche, Alain Duhamel, Sylvie Deheul, Olivier Cottencin, Régis Bordet, Sophie Gautier, Benjamin Rolland
No abstract text is available yet for this article.
February 10, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28185070/antenatal-exposure-and-diseases-in-the-offspring-the-role-of-big-data
#17
LETTER
Christoph R Meier, Susan S Jick
No abstract text is available yet for this article.
February 10, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28185069/comment-on-proactive-regional-pharmacovigilance-system-versus-national-spontaneous-reporting-for-collecting-safety-data-on-concerning-off-label-prescribing-practices-an-example-with-baclofen-and-alcohol-dependence-in-france
#18
LETTER
Alain Braillon
No abstract text is available yet for this article.
February 10, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28181126/anti-angiogenic-tyrosine-kinase-inhibitors-and-reversible-posterior-leukoencephalopathy-syndrome-could-hypomagnesaemia-be-the-trigger
#19
REVIEW
Rashmi R Shah
Reversible posterior leukoencephalopathy syndrome (RPLS), also known frequently as posterior reversible encephalopathy syndrome (PRES), is a characteristic acute neuro-radiology syndrome with clinical presentation that typically includes acute hypertension, seizures and other neurological symptoms and signs. Many patients with RPLS have (a history of) pre-existing hypertension and in receipt of diuretics. It is being diagnosed more frequently and in association with an increasing number of morbidities and medications...
February 9, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28155198/validation-of-new-signal-detection-methods-for-web-query-log-data-compared-to-signal-detection-algorithms-used-with-faers
#20
Susan Colilla, Elad Yom Tov, Ling Zhang, Marie-Laure Kurzinger, Stephanie Tcherny-Lessenot, Catherine Penfornis, Shang Jen, Danny S Gonzalez, Patrick Caubel, Susan Welsh, Juhaeri Juhaeri
INTRODUCTION: Post-marketing drug surveillance is largely based on signals found in spontaneous reports from patients and healthcare providers. Rare adverse drug reactions and adverse events (AEs) that may develop after long-term exposure to a drug or from drug interactions may be missed. The US FDA and others have proposed that web-based data could be mined as a resource to detect latent signals associated with adverse drug reactions. METHODS: Recently, a web-based search query method called a query log reaction score (QLRS) was developed to detect whether AEs associated with certain drugs could be found from search engine query data...
February 2, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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