Risk of diabetic ketoacidosis after exposure to risperidone or olanzapine.

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:Pharmacovigilance, the monitoring of drug safety after marketing approval, highly depends on the adequate reporting of adverse drug reactions (ADRs). To improve pharmacovigilance awareness and future ADR reporting among medical students, we developed and evaluated a student-run pharmacovigilance programme....

journal_title：Drug safety

authors： Schutte T,Tichelaar J,Reumerman MO,van Eekeren R,Rolfes L,van Puijenbroek EP,Richir MC,van Agtmael MA

更新日期：2017-05-01 00:00:00

abstract：:Severe skin adverse drug reactions can result in death, but the rate of such events is fortunately low. The incidences of Stevens-Johnson syndrome and toxic epidermal necrolysis range from 1.2 to 6 per million per year and 0.4 to 1.2 per million per year, respectively. Stevens-Johnson syndrome is fatal in about 5% and...

journal_title：Drug safety

authors： Wolkenstein P,Revuz J

更新日期：1995-07-01 00:00:00

abstract：:Bisphosphonates are the primary pharmacological agents used for the management of osteoporosis and hypercalcaemia of malignant bone disease. The efficacy of these agents in these two conditions has been demonstrated in many well designed trials published over the past 2 decades. The variety of bisphosphonates currentl...

journal_title：Drug safety

authors： Bobba RS,Beattie K,Parkinson B,Kumbhare D,Adachi JD

更新日期：2006-01-01 00:00:00

abstract：BACKGROUND:Automated disproportionality analysis of spontaneous reporting is increasingly used routinely. It can theoretically be influenced by a competition bias for signal detection owing to the presence of reports related to well-established drug-event associations. OBJECTIVE:The aim of the study was to explore the...

journal_title：Drug safety

authors： Pariente A,Avillach P,Salvo F,Thiessard F,Miremont-Salamé G,Fourrier-Reglat A,Haramburu F,Bégaud B,Moore N,Association Française des Centres Régionaux de Pharmacovigilance (CRPV).

更新日期：2012-10-01 00:00:00

abstract：BACKGROUND:Naproxen, ibuprofen and diclofenac are frequently used as comparators in randomized controlled trials (RCTs) on the safety and efficacy of cyclooxygenase (COX)-2 inhibitors. Different comparator doses may influence the results of RCTs. It has been hypothesized that RCTs of COX-2 inhibitors where different do...

journal_title：Drug safety

authors： Stefansdottir G,De Bruin ML,Knol MJ,Grobbee DE,Leufkens HG

更新日期：2011-09-01 00:00:00

abstract：:Complex interactions exist amongst the various components of the neuroendocrine system in order to maintain homeostasis, energy balance and reproductive function. These components include the hypothalamus-pituitary- adrenal and -gonadal axes, the renin-angiotensin-aldosterone system, the sympathetic nervous system and...

journal_title：Drug safety

authors： Ma RC,Kong AP,Chan N,Tong PC,Chan JC

更新日期：2007-01-01 00:00:00

abstract：:Benefit-risk assessment should be ongoing during the life cycle of a pharmaceutical agent. New products are subjected to rigorous registration laws and rules, which attempt to assure the availability and validity of evidence. For older products, bias in benefit-risk assessment is more likely, as a number of safeguards...

journal_title：Drug safety

authors： De Backer TL,Vander Stichele RH,Van Bortel LM

更新日期：2009-01-01 00:00:00

abstract：:Rhythm control in atrial fibrillation (AF) can be achieved using pharmacological therapy. Amiodarone is the most efficacious anti-arrhythmic agent; however, its use is limited due to an unfavourable safety profile, including pro-arrhythmia, thyroid, liver, skin and pulmonary complications. Dronedarone, which is struct...

journal_title：Drug safety

authors： Adlan AM,Lip GY

更新日期：2013-02-01 00:00:00

abstract：INTRODUCTION:Romiplostim is a subcutaneously administered thrombopoietin-receptor agonist approved in the European Union for self-administration (or administration by a caregiver) in selected adult patients with chronic primary immune thrombocytopenia refractory to other treatments. To mitigate the risk of medication e...

journal_title：Drug safety

authors： Schipperus M,Kaiafa G,Taylor L,Wetten S,Kreuzbauer G,Boshier A,Seesaghur A

更新日期：2019-01-01 00:00:00

abstract：BACKGROUND:Depressive disorders and use of antidepressants are associated with adverse effects on sexual function. In pharmacoepidemiological studies, sexual disorders are reported by more than 50 % of patients taking serotonin reuptake inhibitors (SRIs). OBJECTIVE:The aim of this study was to determine the reporting ...

journal_title：Drug safety

authors： Trenque T,Maura G,Herlem E,Vallet C,Sole E,Auriche P,Drame M

更新日期：2013-07-01 00:00:00

abstract：BACKGROUND AND OBJECTIVE:Many drugs that are used to treat children are either not licensed for use in paediatric patients (unlicensed) or prescribed outside the terms of the product licence (off label). The incidence of adverse drug reactions (ADRs) associated with the use of such drugs is yet to be established. This ...

journal_title：Drug safety

authors： Neubert A,Dormann H,Weiss J,Egger T,Criegee-Rieck M,Rascher W,Brune K,Hinz B

更新日期：2004-01-01 00:00:00

abstract：:Drug eruptions are among the most common adverse drug reactions, affecting approximately 3% of hospitalised patients. Although the rate of severe cutaneous adverse reactions to medications is low, these reactions can affect anyone who takes medication, and can result in death or disability. Two general patterns can be...

journal_title：Drug safety

authors： Valeyrie-Allanore L,Sassolas B,Roujeau JC

更新日期：2007-01-01 00:00:00

abstract：INTRODUCTION:Checkpoint inhibitor drugs including ipilimumab have been reported to induce intestinal injury. OBJECTIVE:We aimed to evaluate the risk of chronic (> 6 weeks) enterocolitis following ipilimumab administration, and the likelihood that an enteritis vs colitis or enterocolitis is seen. PATIENTS AND METHODS:...

journal_title：Drug safety

authors： Witges K,Shafer LA,Zarychanski R,Abou-Setta AM,Rabbani R,Dingwall O,Bernstein CN

更新日期：2020-12-01 00:00:00

abstract：:Cutaneous adverse drug reactions are a frequent occurrence and have been reported in more than 2% of hospitalised patients. Among the most commonly involved drugs are sulphonamides, penicillins, anticonvulsants and non-steroidal anti-inflammatory drugs. Two groups of mechanisms are involved in the pathogenesis of drug...

journal_title：Drug safety

authors： Raviglione MC,Pablos-Mendez A,Battan R

更新日期：1990-01-01 00:00:00

abstract：:The New Zealand Intensive Medicines Monitoring Programme (IMMP) undertakes prospective observational cohort studies on selected new drugs in the early postmarketing period using prescription-event monitoring (PEM) methodology with the purpose of identifying signals of previously unrecognised ADRs and establishing risk...

journal_title：Drug safety

authors： Coulter DM

更新日期：2002-01-01 00:00:00

abstract：:The biologics have revolutionized the treatment of rheumatoid arthritis (RA). However, there are still patients that are difficult to control and a cure is still not achievable. Tofacitinib, a Janus kinase (JAK) inhibitor is an orally available, new-in-class, disease-modifying anti-rheumatic drug with similar efficacy...

journal_title：Drug safety

authors： Yamaoka K

更新日期：2016-09-01 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：:Cholinesterase inhibitors are currently the most established treatment strategy in Alzheimer's disease. The treatment effect appears mainly to be symptomatic. Effects on progression of the disease following long term treatment, and possible neuroprotective effects, have been investigated. Delay until nursing home plac...

journal_title：Drug safety

authors： Nordberg A,Svensson AL

更新日期：1998-12-01 00:00:00

abstract：:Safe and effective treatment of major depression, one of the most common comorbid conditions in individuals infected with HIV, significantly lowers morbidity and mortality from HIV disease. However, optimal treatment of both conditions is complicated by interactions between the disease processes as well as the pharmac...

journal_title：Drug safety

authors： Pieper AA,Treisman GJ

更新日期：2005-01-01 00:00:00

abstract：:Eosinophils play a pivotal role in the inflammatory pathology of asthma and have been the target of new biologic treatments for patients with eosinophilic asthma. Given the central role of interleukin (IL)-5 in the eosinophil lifecycle, several therapies directed against the IL-5 pathway have been developed, including...

journal_title：Drug safety

authors： Jackson DJ,Korn S,Mathur SK,Barker P,Meka VG,Martin UJ,Zangrilli JG

更新日期：2020-05-01 00:00:00

abstract：:Cytokines are now commonly used in the treatment of many conditions, especially cancer, haematological malignancies and chronic viral hepatitis. With some of these cytokines, clinical induction and/or exacerbation of autoimmune manifestations have been observed. This has been the case with interferon-alpha and interfe...

journal_title：Drug safety

authors： Miossec P

更新日期：1997-08-01 00:00:00

abstract：:In this narrative review, a brief summary of theoretical approaches to risk perception is followed by an analysis of some of the special factors influencing risk perception and risk communication in sub-Saharan Africa. Examples of recent and emergent local medicines and vaccine controversies in several countries are g...

journal_title：Drug safety

authors： Dodoo A,Hugman B

更新日期：2012-11-01 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：:Thallium poisoning seldom occurs in Spain. This article reports 5 cases of thallium poisoning, of which 4 of the patients belonged to the same family. The cases occurred in or near Granada between 1985 and 1987. The symptoms were initially gastrointestinal (vomiting, abdominal pain, gastrointestinal haemorrhage, etc.)...

journal_title：Drug safety

authors： Villanueva E,Hernandez-Cueto C,Lachica E,Rodrigo MD,Ramos V

更新日期：1990-09-01 00:00:00

abstract：:The prevalence of pain is high in multimorbid patients and they can experience a multitude of painful conditions. The changes in physiology and homeostasis associated with multimorbidity and increasing age and the immature metabolism of neonates all increase the risk of toxicity from analgesics. Altered pharmacokineti...

journal_title：Drug safety

authors： Wilder-Smith CH

更新日期：1998-06-01 00:00:00

abstract：BACKGROUND:Thorough QT studies are typically conducted for drugs with systemic bioavailability and include a positive control, typically moxifloxacin, with a well-described QTc effect. OBJECTIVE:This study tested two hypotheses: that (i) re-measuring the QT intervals based on electrocardiogram (ECG) pattern similarity...

journal_title：Drug safety

authors： Johannesen L,Garnett C,Malik M

更新日期：2014-03-01 00:00:00

abstract：: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 ...

journal_title：Drug safety

authors： Ralph Edwards I

更新日期：2017-05-01 00:00:00

abstract：:Epidural analgesia for caesarean section is increasingly used and is gradually replacing general anaesthesia. Hypotension is one of the main risks: preloading of the maternal circulation is used to prevent maternal hypotension and its consequences. For this, various colloid and crystalloid solutions are used. We repor...

journal_title：Drug safety

authors： Barbier P,Jonville AP,Autret E,Coureau C

更新日期：1992-01-01 00:00:00

abstract：:This 'Erice Call for Change' is a report from a group of experts, patients and patient representatives who met in Erice in September 2019 following previous similar meetings after the original Erice Declaration (1996). The aim of the meeting was to discuss the challenge of causal complexity and individual variation in...

journal_title：Drug safety

authors： Rocca E,Anjum RL

更新日期：2020-06-01 00:00:00