PCSK9 Inhibitors and Neurocognitive Adverse Drug Reactions: Analysis of Individual Case Safety Reports from the Eudravigilance Database.

abstract：:Adverse drug effects are manifold and heterogenous. Many situations may hamper the signalling (i.e. the detection of early warning signs) of adverse effects and new signals often differ from previous experiences. Signals have qualitative and quantitative aspects. Different categories of adverse effects need different ...

journal_title：Drug safety

authors： Meyboom RH,Egberts AC,Edwards IR,Hekster YA,de Koning FH,Gribnau FW

更新日期：1997-06-01 00:00:00

abstract：:Although travellers' diarrhoea can sometimes be associated with postinfectious complications, the condition is typically self-limiting. The infectious-diarrhoea guidelines subcommittees of the Infectious Disease Society of America and the American College of Gastroenterology recommend empirical antibacterial therapy f...

journal_title：Drug safety

authors： Ericsson CD

更新日期：2006-01-01 00:00:00

abstract：:Blinatumomab is the first-and-only Food and Drug Administration (FDA)-approved cluster of differentiation (CD) 19-directed CD3 bispecific T-cell engager (BiTE®) immunotherapy. It is currently FDA approved for the treatment of adults and children with Philadelphia chromosome-positive (Ph+) and Philadelphia chromosome-n...

journal_title：Drug safety

authors： Stein A,Franklin JL,Chia VM,Arrindell D,Kormany W,Wright J,Parson M,Amouzadeh HR,Choudhry J,Joseph G

更新日期：2019-05-01 00:00:00

abstract：:Randomised clinical trials offer a unique opportunity for capturing safety information under a controlled setting that minimises biases in the comparison of different therapeutic options. Nevertheless, empirical evidence across diverse medical fields suggests that the reporting of safety information in clinical trials...

journal_title：Drug safety

authors： Ioannidis JP,Lau J

更新日期：2002-01-01 00:00:00

abstract：:The new generation fluoroquinolones -- sparfloxacin, levofloxacin, grepafloxacin and trovafloxacin -- have been designed to respond to the clinical need for extended antimicrobial cover in the face of increasing global microbial resistance. Their main focus is in the treatment of respiratory infections, particularly t...

journal_title：Drug safety

authors： Lode H

更新日期：1999-08-01 00:00:00

abstract：:Intranasal corticosteroids and intranasal antihistamines are efficacious topical therapies in the treatment of allergic rhinitis. This review addresses their relative roles in the management of this disease, focusing on their safety and tolerability profiles. The intranasal route of administration delivers drug direct...

journal_title：Drug safety

authors： Salib RJ,Howarth PH

更新日期：2003-01-01 00:00:00

abstract：:Most antiviral drugs are nucleoside analogues with potential teratogenic, embryotoxic, carcinogenic and antiproliferative activities. They must be administered with caution during pregnancy, because some are known teratogens (e.g. amantadine) and a similar propensity cannot be entirely excluded for others (e.g. aciclo...

journal_title：Drug safety

authors： Morris DJ

更新日期：1994-04-01 00:00:00

abstract：:Rechallenge is defined as the readministration of a medication suspected of being a possible cause of an adverse reaction and which has been discontinued as result. It may be unintentional when the appearance of a reaction was initially not attributed to the medication. A rechallenge may be intentional when a prescrib...

journal_title：Drug safety

authors： Stanulović V,Venegoni M,Edwards B

更新日期：2013-03-01 00:00:00

abstract：BACKGROUND:Atypical antipsychotics have been associated with metabolic abnormalities including impaired glucose metabolism, exacerbation of existing diabetes mellitus and new-onset type 2 diabetes. Not all atypical antipsychotic agents appear to have the same propensity to cause these complications. OBJECTIVE:To asses...

journal_title：Drug safety

authors： Ramaswamy K,Kozma CM,Nasrallah H

更新日期：2007-01-01 00:00:00

abstract：:Phytoestrogens, plant chemicals classified as isoflavones, coumestans and lignans, display estrogen-like activity because of their structural similarity to human estrogens and exhibit high affinity binding for the estrogen receptor beta. They are common components of food items such as grains, beans, fruits and nuts. ...

journal_title：Drug safety

authors： Sirtori CR

更新日期：2001-01-01 00:00:00

abstract：:Menorrhagia affects the lives of many women. The assessment of menstrual flow is highly subjective and gauging the severity of the condition by objective assessment of menstrual blood loss is impractical. In treating menorrhagia, the primary aim should be to improve quality of life. Women are willing to undergo quite ...

journal_title：Drug safety

authors： Roy SN,Bhattacharya S

更新日期：2004-01-01 00:00:00

abstract：:In August 2015, the US Food and Drug Administration (FDA) made the controversial decision to approve flibanserin (Addyi®) for women experiencing hypoactive sexual desire disorder. A number of factors contributed to disagreements regarding the FDA's decision, including the product's two prior failed FDA reviews, the un...

journal_title：Drug safety

authors： Baksh SN,Gellad WF,Alexander GC

更新日期：2016-05-01 00:00:00

abstract：BACKGROUND:Researchers using observational data to understand drug effects must make a number of analytic design choices that suit the characteristics of the data and the subject of the study. Review of the published literature suggests that there is a lack of consistency even when addressing the same research question...

journal_title：Drug safety

authors： Stang PE,Ryan PB,Overhage JM,Schuemie MJ,Hartzema AG,Welebob E

更新日期：2013-10-01 00:00:00

abstract：:As the variety and range of pharmaceutical agents available to the medical profession continues to expand, one unavoidable effect will be an increase in drug-induced disease, including cardiovascular disorders. However, given the high rates of cardiovascular disease and prevalence of recognised cardiovascular risk fac...

journal_title：Drug safety

authors： Murphy CA,Dargie HJ

更新日期：2007-01-01 00:00:00

abstract：INTRODUCTION:The case-population approach compares exposure among cases to that of their source population. By using aggregated data to estimate the denominator, this approach can provide a real-time estimate of an association that could be particularly valuable to explore urgent vaccine safety concerns and to generate...

journal_title：Drug safety

authors： Théophile H,Moore N,Robinson P,Bégaud B,Pariente A

更新日期：2016-12-01 00:00:00

abstract：BACKGROUND:Psoriasis is a chronic autoimmune disease characterized by infiltration of the dermis and epidermis by activated T cells and the hyperproliferation and abnormal differentiation of keratinocytes. It is a life-long disease with alternating periods of remission and recurrence. Efalizumab is a humanized, recombi...

journal_title：Drug safety

authors： Hamilton T,Menter A,Caro I,Compton P,Sobell J,Papp KA

更新日期：2008-01-01 00:00:00

abstract：:After initial enthusiasm, the use of monoamine oxidase inhibitors (MAOIs) has been limited by the wide range of MAOI-drug and MAOI-food interactions that are possible, particularly with sympathomimetic medications or tyramine-containing foods, resulting in hypertensive reactions. Despite their clinical benefits, this ...

journal_title：Drug safety

authors： Livingston MG,Livingston HM

更新日期：1996-04-01 00:00:00

abstract：:Highly publicized safety issues of medicinal products in recent years and the accompanying political pressure have forced both the US FDA and the European Medicines Agency (EMA) to implement stronger regulations concerning pharmacovigilance. These legislative changes demand more proactive risk management strategies of...

journal_title：Drug safety

authors： Ebbers HC,Mantel-Teeuwisse AK,Moors EH,Schellekens H,Leufkens HG

更新日期：2011-04-01 00:00:00

abstract：:The most frequently reported symptoms in heart failure are fatigue and dyspnoea, which limit exercise tolerance. However, several surveys reveal other changes in physical and psychological well-being which affect the patient's perception of 'quality of life'. The introduction of new treatments for heart failure has st...

journal_title：Drug safety

authors： Waller DG

更新日期：1991-07-01 00:00:00

abstract：:The aim of this review is to analyse and summarise the literature data about the incidence of weight gain in patients exposed to atypical antipsychotics during long-term (>or=1 year) treatment regimens. Despite the clinical relevance of the topic, the vast majority of reviewed studies showed methodological limitations...

journal_title：Drug safety

authors： Gentile S

更新日期：2006-01-01 00:00:00

abstract：:The main goal of pharmacological research in the field of topical corticosteroids (TCs) is to dissociate efficacy and adverse effects as much as possible. The optimal use of TCs, i.e. the careful evaluation of the benefit/risk ratio, depends on: (i) the chemical structure of the TC; (ii) the type of vehicle; (iii) the...

journal_title：Drug safety

authors： Mori M,Pimpinelli N,Giannotti B

更新日期：1994-05-01 00:00:00

abstract：BACKGROUND:Screening large databases of spontaneous case reports of possible adverse drug reactions (ADRs) is an established method of identifying hitherto unknown adverse effects of medicinal products; however, there is a lack of consensus concerning the value of formal statistical screening procedures in guiding such...

journal_title：Drug safety

authors： Alvarez Y,Hidalgo A,Maignen F,Slattery J

更新日期：2010-06-01 00:00:00

abstract：INTRODUCTION:Electronic healthcare databases (EHDs) are used increasingly for post-marketing drug safety surveillance and pharmacoepidemiology in Europe and North America. However, few studies have examined the potential of these data sources in China. METHODS:Three major types of EHDs in China (i.e., a regional commu...

journal_title：Drug safety

authors： Yang Y,Zhou X,Gao S,Lin H,Xie Y,Feng Y,Huang K,Zhan S

更新日期：2018-01-01 00:00:00

abstract：:The increasing incidence of Crohn's disease has lead to speculation about changes in exposures to environmental or infectious agents. Considerable attention has focused on the role of measles infection and/or vaccination in the pathogenesis of Crohn's disease and ulcerative colitis. Current evidence regarding the asso...

journal_title：Drug safety

authors： Davis RL,Bohlke K

更新日期：2001-01-01 00:00:00

abstract：:The available antihyperlipidaemic drugs are generally safe and effective, and major systemic adverse effects are uncommon. However, because of their complex mechanisms of action, careful monitoring is required to identify and correct potential drug interactions. Bile acid sequestrants are the most difficult of these a...

journal_title：Drug safety

authors： Farmer JA,Gotto AM Jr

更新日期：1994-11-01 00:00:00

abstract：:Propofol (2, 6-diisopropylphenol) is a potent intravenous hypnotic agent that is widely used in adults and children for sedation and the induction and maintenance of anaesthesia. Propofol has gained popularity for its rapid onset and rapid recovery even after prolonged use, and for the neuroprotection conferred. Howev...

journal_title：Drug safety

authors： Fodale V,La Monaca E

更新日期：2008-01-01 00:00:00

abstract：BACKGROUND:Case reports have related the use of HMG-CoA reductase inhibitors ('statins') to Parkinson's disease (PD). Paradoxically, however, statins may have potentially beneficial effects on neurodegenerative diseases due to their anti-inflammatory properties. OBJECTIVE:To explore the risk of the development of PD i...

journal_title：Drug safety

authors： Becker C,Jick SS,Meier CR

更新日期：2008-01-01 00:00:00

abstract：:Quinolones are a class of antibacterial agents for the treatment of several infectious diseases (e.g. urinary and respiratory tract infections). They are used worldwide due to their broad spectrum of activity, high bioavailability and good safety profile. The safety profile varies from quinolone to quinolone. The aim ...

journal_title：Drug safety

authors： Tomé AM,Filipe A

更新日期：2011-06-01 00:00:00

abstract：INTRODUCTION:New pharmacovigilance legislation was adopted in the EU in 2010 and became operational in July 2012. The legislation placed an obligation on all national competent authorities (NCAs) and marketing authorisation holders (MAHs) to record and report cases of suspected adverse drug reactions (ADRs) received fr...

journal_title：Drug safety

authors： Banovac M,Candore G,Slattery J,Houÿez F,Haerry D,Genov G,Arlett P

更新日期：2017-07-01 00:00:00

abstract：BACKGROUND:Over-the-counter analgesics (OTCAs), principally paracetamol (acetaminophen)-containing compounds and NSAIDs, are commonly used medications. Guidelines for the use of these agents in patients with chronic liver disease (CLD) are not available, despite the possibility that such patients may be more susceptibl...

journal_title：Drug safety

authors： Rossi S,Assis DN,Awsare M,Brunner M,Skole K,Rai J,Andrel J,Herrine SK,Reddy RK,Navarro VJ

更新日期：2008-01-01 00:00:00