Safety of zafirlukast: results of a postmarketing surveillance study on 7976 patients in England.

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：:To estimate the frequency of adverse effects associated with the use of the transdermal nicotine patch, we abstracted and analysed data from 47 reports of 35 clinical trials. The meta-analysis presented here represents a synthesis of data from 41 groups of nicotine patch recipients totalling 5501 patients, and 33 grou...

journal_title：Drug safety

authors： Greenland S,Satterfield MH,Lanes SF

更新日期：1998-04-01 00:00:00

abstract：:Current antiretroviral therapy has lead to longer survival in patients infected with HIV, but it is also associated with new and important problems. Body fat redistribution and metabolic abnormalities, the so-called lipodystrophy syndrome, are among the most prevalent and worrisome ones. While an increasing number of ...

journal_title：Drug safety

authors： Martínez E,Garcia-Viejo MA,Blanch L,Gatell JM

更新日期：2001-01-01 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：BACKGROUND:A number of published studies compare adverse event rates for drugs on the basis of reports in the US FDA Adverse Event Reporting System (AERS). While the AERS data have the advantage of timely availability and a large capture population, the database is subject to many significant biases, and lacks complete...

journal_title：Drug safety

authors： Hochberg AM,Pearson RK,O'Hara DJ,Reisinger SJ

更新日期：2009-01-01 00:00:00

abstract：BACKGROUND:There are no head-to-head randomized controlled trials comparing different direct oral anticoagulants (DOACs). Thus, we systematically reviewed and meta-analyzed observational studies assessing the comparative effectiveness and safety of DOACs for stroke prevention in patients with atrial fibrillation (AF). ...

journal_title：Drug safety

authors： Douros A,Durand M,Doyle CM,Yoon S,Reynier P,Filion KB

更新日期：2019-10-01 00:00:00

abstract：:Opioids have been accepted as appropriate treatment for acute and cancer pain, but their role in the management of chronic nonmalignant pain is the subject of much debate, mainly due to concerns about waning efficacy, the potential for neuropsychological impairment and the development of drug addiction. Controlled cli...

journal_title：Drug safety

authors： Bannwarth B

更新日期：1999-10-01 00:00:00

abstract：:Randomized controlled trials always report the dose assessed and usually include a measure of adherence. By comparison, observational studies assessing medication safety often fail to report the dose used and rarely report any measure of adherence to therapy. This limits the ability to control for differences in doses...

journal_title：Drug safety

authors： Roughead EE,Pratt NL

更新日期：2015-12-01 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:Spontaneous reports of suspected adverse drug reactions to regulatory bodies and market authorization holders are important in pharmacovigilance. Follow-up information, which can be difficult to obtain, is often required from reporters; therefore, we developed targeted follow-up letters that we hoped would m...

journal_title：Drug safety

authors： Anton C,Cox AR,Ferner RE

更新日期：2009-01-01 00:00:00

abstract：BACKGROUND:It has been shown that the abrupt cessation of treatment with beta-adrenoceptor antagonists (beta-blockers) increases the risk of myocardial infarction in patients with hypertension. As beta-blockers differ in their pharmacokinetic and pharmacodynamic properties, this risk of discontinuation might also diffe...

journal_title：Drug safety

authors： Teichert M,de Smet PA,Hofman A,Witteman JC,Stricker BH

更新日期：2007-01-01 00:00:00

abstract：:Impulse control disorders (ICDs) are a well-known adverse effect of dopamine agonists (DAAs). This critical review aims to summarize data on the prevalence and factors associated with the development of an ICD simultaneous to DAA use. A search of two electronic databases was completed from inception to July 2017. The ...

journal_title：Drug safety

authors： Grall-Bronnec M,Victorri-Vigneau C,Donnio Y,Leboucher J,Rousselet M,Thiabaud E,Zreika N,Derkinderen P,Challet-Bouju G

更新日期：2018-01-01 00:00:00

abstract：BACKGROUND:Newly approved drugs, in comparison with older drugs, are more often prescribed to patients who have not responded satisfactorily to established related drugs or as first-line therapy to patients with a high baseline risk for adverse outcomes (i.e. channelling). However, these patients are less likely to ben...

journal_title：Drug safety

authors： Layton D,Souverein PC,Heerdink ER,Shakir SA,Egberts AC

更新日期：2008-01-01 00:00:00

abstract：:The prognosis is generally poor for patients who experience a cardiac arrest. The most common causes of sudden cardiac arrest are massive pulmonary embolism (PE) and acute myocardial infarction (MI). While thrombolysis is a first-line treatment option in massive PE and acute MI, cardiopulmonary resuscitation (CPR) has...

journal_title：Drug safety

authors： Spöhr F,Böttiger BW

更新日期：2003-01-01 00:00:00

abstract：BACKGROUND:Patients receiving warfarin therapy are discouraged from taking herbal medicines. Whether patients adhere to this advice and, if they do not, the types of products they use, are not known. OBJECTIVE:The objective of this observational study was to estimate the magnitude of use of herbal medicines among Chin...

journal_title：Drug safety

authors： Wong RS,Cheng G,Chan TY

更新日期：2003-01-01 00:00:00

abstract：:Paraquat is a bipyridyl compound with no known chronic toxicity or teratogenicity. It is poorly absorbed when inhaled, but causes severe illness when ingested orally, death usually occurring within 2 days of ingestion of 50 mg/kg. At lower doses death may be delayed for several weeks. The toxic compound accumulates in...

journal_title：Drug safety

authors： Bismuth C,Garnier R,Baud FJ,Muszynski J,Keyes C

更新日期：1990-07-01 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：BACKGROUND:For many regularly used drugs, evidence for safe use in pregnancy has not been established. Despite this, international studies have identified high levels of drug prescribing among pregnant women. OBJECTIVE:To investigate the patterns of prescribing of drugs to women who gave birth in Tayside, Scotland, in...

journal_title：Drug safety

authors： Irvine L,Flynn RW,Libby G,Crombie IK,Evans JM

更新日期：2010-07-01 00:00:00

abstract：:Concomitant use of antacid preparations with other medications is common. The potential for antacid-drug interactions is dependent upon the chemistry and physical properties of the antacid preparation. The intragastric release of free aluminum and magnesium ions has potent effects on gastrointestinal function and on d...

journal_title：Drug safety

authors： Sadowski DC

更新日期：1994-12-01 00:00:00

abstract：:Drug-induced QT interval prolongation is now a major concern in safety pharmacology. Regulatory authorities such as the US FDA and the European Medicines Agency require in vitro testing of all drug candidates against the potential risk for QT interval prolongation prior to clinical trials. Common in vitro methods incl...

journal_title：Drug safety

authors： Meyer T,Boven KH,Günther E,Fejtl M

更新日期：2004-01-01 00:00:00

abstract：INTRODUCTION:Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9Is) were associated with a risk of neurocognitive adverse drug reactions (ADRs). OBJECTIVE:We aimed to investigate the occurrence of neuropsychiatric ADRs related to PCSK9Is. METHODS:We analyzed Individual Case Safety Reports (ICSRs) sent thr...

journal_title：Drug safety

authors： di Mauro G,Zinzi A,Scavone C,Mascolo A,Gaio M,Sportiello L,Ferrajolo C,Rafaniello C,Rossi F,Capuano A

更新日期：2020-12-22 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：BACKGROUND:Individual case reports of suspected harm from medicines are fundamental for signal detection in postmarketing surveillance. Their effective analysis requires reliable data and one challenge is report duplication. These are multiple unlinked records describing the same suspected adverse drug reaction (ADR) i...

journal_title：Drug safety

authors： Tregunno PM,Fink DB,Fernandez-Fernandez C,Lázaro-Bengoa E,Norén GN

更新日期：2014-04-01 00:00:00

abstract：:Drug safety is not a matter for healthcare professionals alone. Patients are also involved, at three different levels: (i) in the behaviours patients adopt to reduce the adverse effects of the drugs; (ii) in regard to what some doctors say to their patients about drug risks; and (iii) in what the pharmaceutical indust...

journal_title：Drug safety

authors： Fainzang S

更新日期：2010-08-01 00:00:00

abstract：:Lipodystrophy complications, including lipoatrophy (pathological fat loss) and metabolic complications, have emerged as important long-term toxicities associated with antiretroviral therapy in the current era. The wealth of data that has accumulated over the past 6 years has now clarified the contribution of specific ...

journal_title：Drug safety

authors： Nolan D

更新日期：2005-01-01 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：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：: ...

journal_title：Drug safety

authors： Kawada T

更新日期：2018-06-01 00:00:00

abstract：BACKGROUND:An association between oral contraceptive (OC) use and venous thromboembolism (VTE) has long been recognized. However, no summary estimates of the increase in VTE risk associated with OC use have been available since 1995, and no meta-analyses have evaluated the VTE risk of new preparations containing drospi...

journal_title：Drug safety

authors： Manzoli L,De Vito C,Marzuillo C,Boccia A,Villari P

更新日期：2012-03-01 00:00:00

abstract：INTRODUCTION:As asthma medications are frequently prescribed for children, knowledge of the safety of these drugs in the paediatric population is important. Although spontaneous reports cannot be used to prove causality of adverse events, they are important in the detection of safety signals. OBJECTIVE:Our objective w...

journal_title：Drug safety

authors： Baan EJ,de Smet VA,Hoeve CE,Pacurariu AC,Sturkenboom MCJM,de Jongste JC,Janssens HM,Verhamme KMC

更新日期：2020-01-01 00:00:00