The clinical implications of inhibition of the inducible form of cyclo-oxygenase.

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：INTRODUCTION:While medical chart review remains the gold standard to validate health conditions or events identified in administrative claims and electronic health record databases, it is time consuming, expensive and can involve subjective decisions. AIM:The aim of this study was to describe the landscape of technolo...

journal_title：Drug safety

authors： Straub L,Gagne JJ,Maro JC,Nguyen MD,Beaulieu N,Brown JS,Kennedy A,Johnson M,Wright A,Zhou L,Wang SV

更新日期：2019-09-01 00:00:00

abstract：INTRODUCTION:Although the mortality risk associated with tramadol use in children has triggered the revision of tramadol drug labeling, the mortality risk in adults has not been thoroughly explored. OBJECTIVE:The objective of this study was to evaluate whether tramadol use is associated with mortality in various risk ...

journal_title：Drug safety

authors： Jeong S,Tchoe HJ,Li J,Shin JY

更新日期：2019-06-01 00:00:00

abstract：BACKGROUND:Medication-related adverse events (MRAEs) form a large proportion of all adverse events in hospitalized patients and are associated with considerable preventable harm. Detailed information on harm related to drugs administered during hospitalization is scarce. Knowledge of the nature and preventability of MR...

journal_title：Drug safety

authors： Hoonhout LH,de Bruijne MC,Wagner C,Asscheman H,van der Wal G,van Tulder MW

更新日期：2010-10-01 00:00:00

abstract：INTRODUCTION:The prevalence of polymorphisms among the metabolising enzymes and pharmacodynamic receptors relevant for the thiazolidinediones differs by ethnic group, a factor that may modify risk of adverse drug events. OBJECTIVE:The aim of the study was to determine if the risk of oedema or heart failure associated ...

journal_title：Drug safety

authors： Roughead EE,Chan EW,Choi NK,Kimura M,Kimura T,Kubota K,Lai EC,Man KK,Nguyen TA,Ooba N,Park BJ,Sato T,Shin JY,Wang T,Griffiths J,Wong IC,Yang YH,Pratt NL

更新日期：2015-09-01 00:00:00

abstract：:Pharmacovigilance science has traditionally been a discipline focussed on the postmarketing or post-authorisation period, with due attention directed towards pre-clinical safety data, clinical trials and adverse events. As the biological sciences have evolved, pharmacovigilance has slowly shifted toward earlier, proac...

journal_title：Drug safety

authors： Hartford CG,Petchel KS,Mickail H,Perez-Gutthann S,McHale M,Grana JM,Marquez P

更新日期：2006-01-01 00:00:00

abstract：OBJECTIVE:During proton pump inhibitor (PPI) use, in clinical trials, headache is one of the most frequently reported adverse events (frequency 1.3 to 8.8%), while results of one observational study indicate that headache is the fifth most frequently reported adverse event (incidence densities 2.5 to 4.6 per 1000 patie...

journal_title：Drug safety

authors： Claessens AA,Heerdink ER,van Eijk JT,Lamers CB,Leufkens HG

更新日期：2002-01-01 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：INTRODUCTION:The use of mobile apps is increasing in medicine. In pharmacovigilance, mobile apps may help to increase adverse drug reaction reporting and improve the communication of safety issues. The Toulouse University Pharmacovigilance Center has developed VigiBIP®, a free smartphone app available on Android and Ap...

journal_title：Drug safety

authors： Montastruc F,Bagheri H,Lacroix I,Damase-Michel C,Chebane L,Rousseau V,Jouanjus E,Lapeyre-Mestre M,Durrieu G,Montastruc JL

更新日期：2018-05-01 00:00:00

abstract：INTRODUCTION:Adverse drug events (ADEs) may represent an important item of expenditure for healthcare systems and their prevention could be associated with a relevant cost saving. OBJECTIVE:The objective of this study was to simulate the annual economic burden for ADEs in Tuscany (Italy) and the potential cost savings...

journal_title：Drug safety

authors： Convertino I,Salvadori S,Pecori A,Galiulo MT,Ferraro S,Parrilli M,Corona T,Turchetti G,Blandizzi C,Tuccori M

更新日期：2019-03-01 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:In the UK, spontaneous reporting of suspected adverse drug reactions (ADRs) by healthcare professionals has been in operation since 1964 through the Yellow Card Scheme (YCS). From 2005, patients themselves have been able to submit Yellow Card reports. OBJECTIVE:To compare patient characteristics, suspected ...

journal_title：Drug safety

authors： McLernon DJ,Bond CM,Hannaford PC,Watson MC,Lee AJ,Hazell L,Avery A,Yellow Card Collaboration.

更新日期：2010-09-01 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：:Drug-induced torsade de pointes is a rare life-threatening adverse drug reaction (ADR) which is strongly influenced by gender. Drugs that prolong cardiac repolarisation include antiarrhythmics, gastrokinetics, antipsychotics, antihistamines and antibacterials. Such drugs share the potential to block cardiac voltage-ga...

journal_title：Drug safety

authors： Drici MD,Clément N

更新日期：2001-01-01 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：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：:Women who discover they are pregnant after exposure to a drug and pregnant women who have a condition that requires continued treatment during pregnancy are told to balance the benefits and risks of the exposure to justify continuation of treatment, discontinuation of treatment or, possibly, pregnancy termination. How...

journal_title：Drug safety

authors： Shields KE,Wiholm BE,Hostelley LS,Striano LF,Arena SR,Sharrar RG

更新日期：2004-01-01 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：:Neuropsychiatric adverse effects related to potent antiretroviral therapy are among the complications that can lead to poor adherence, treatment interruptions, or change of antiretroviral therapy regimens. For a historical perspective, we review early literature and case reports with CNS adverse effects attributed to ...

journal_title：Drug safety

authors： Cespedes MS,Aberg JA

更新日期：2006-01-01 00:00:00

abstract：:Transdermal fentanyl is effective and well tolerated for the treatment of chronic pain caused by malignancy and non-malignant conditions when administered according to the manufacturer's recommendations. Compared with oral opioids, the advantages of transdermal fentanyl include a lower incidence and impact of adverse ...

journal_title：Drug safety

authors： Kornick CA,Santiago-Palma J,Moryl N,Payne R,Obbens EA

更新日期：2003-01-01 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：INTRODUCTION:An often key component to coordinating surveillance activities across distributed networks is the design and implementation of a common data model (CDM). The purpose of this study was to evaluate two drug safety surveillance CDMs from an ecosystem perspective to better understand how differences in CDMs an...

journal_title：Drug safety

authors： Xu Y,Zhou X,Suehs BT,Hartzema AG,Kahn MG,Moride Y,Sauer BC,Liu Q,Moll K,Pasquale MK,Nair VP,Bate A

更新日期：2015-08-01 00:00:00

abstract：INTRODUCTION:Valbenazine is a novel vesicular monoamine transporter 2 inhibitor approved for the treatment of tardive dyskinesia in adults. OBJECTIVE:Using data from double-blind, placebo-controlled trials, analyses were conducted to evaluate the cardiovascular effects of once-daily valbenazine in patients with a psyc...

journal_title：Drug safety

authors： Thai-Cuarto D,O'Brien CF,Jimenez R,Liang GS,Burke J

更新日期：2018-04-01 00:00:00

abstract：BACKGROUND:Problematic prescription drug use is reflected by or associated with drug-seeking aberrant behaviours. Research gaps include lack of post-marketing evidence and instruments. As part of the pharmacovigilance requirements, a risk management plan was developed for fentanyl buccal tablets (FEBT) by the manufactu...

journal_title：Drug safety

authors： Layton D,Osborne V,Al-Shukri M,Shakir SA

更新日期：2014-08-01 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：INTRODUCTION AND OBJECTIVE:The therapeutic role of fecal microbiota transplantation in ulcerative colitis varies across different reports. This study aims to evaluate the long-term safety and efficacy of a strategy called step-up fecal microbiota transplantation for ulcerative colitis. METHODS:Two clinical trials (NCT...

journal_title：Drug safety

authors： Ding X,Li Q,Li P,Zhang T,Cui B,Ji G,Lu X,Zhang F

更新日期：2019-07-01 00:00:00

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：: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：INTRODUCTION:Adverse drug reactions (ADRs) are unintended reactions caused by a drug or combination of drugs taken by a patient. The current safety surveillance system relies on spontaneous reporting systems (SRSs) and more recently on observational health data; however, ADR detection may be delayed and lack geographic...

journal_title：Drug safety

authors： Li Y,Jimeno Yepes A,Xiao C

更新日期：2020-09-01 00:00:00

abstract：:The New Zealand Medicines Adverse Reactions Committee has been monitoring reports of adverse drug reactions (ADRs) since 1965. We wished to determine the numbers of voluntary reports of different types of ADR to all nonsteroidal anti-inflammatory drugs (NSAIDs) over a long time period and relate these to age. As the e...

journal_title：Drug safety

authors： Clark DW,Ghose K

更新日期：1992-11-01 00:00:00