Identifying the incidence of rash, Stevens-Johnson syndrome and toxic epidermal necrolysis in patients taking lamotrigine: a systematic review of 122 randomized controlled trials [PDF]
Lamotrigine is an antiepileptic drug used for the treatment of epilepsy, bipolar disorder and numerous off-label uses. The development of rash significantly affects its use. The most concerning of these adverse reactions is Stevens-Johnson syndrome/toxic
Romi Bloom, Kyle T. Amber
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Low awareness of adverse drug reaction reporting systems: a consumer survey [PDF]
To determine levels of public awareness of consumer adverse drug reaction (ADR) reporting systems in Australia.Cross-sectional study conducted in 2012 of residents of the Hunter Valley region of New South Wales, who participated in a computer-assisted telephone interview (CATI), and a national sample, who completed an online Pureprofile survey ...
Robertson, Jane, Newby, David A.
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Integrating pharmacovigilance into the routine of pharmacy department: experience of nine years [PDF]
Objective: To describe our pharmacovigilance program and to analyze the reported adverse drug reactions. Method: Observational longitudinal study conducted from 2008 to 2016.
Ariadna Pérez-Ricart +4 more
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Adverse drug reactions due to ophthalmic drugs: Reporting system in India
Sir, All new drugs including those for ophthalmic use are approved by Drugs Controller General (India) of Central Drugs Standard Control Organization (CDSCO) as per the schedule Y of Drugs and Cosmetics (D and C) Act 1940 and Rules 1945 thereunder after reviewing its efficacy and safety in Indian population.
Vivekanandan Kalaiselvan +2 more
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Spontaneous reporting systems may generate a large volume of information in real world conditions with a relatively low cost. Disproportionality measures are useful to indicate and quantify unexpected safety issues associated with a given drug-event pair
Flávia Campos Barcelos +4 more
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Heuristic Evaluation of adverse drug reaction reporting System
Abstract Background Adverse drug reactions as an ongoing public health issue, affects various aspects of society. This study aims to conduct a comprehensive study of usability and to evaluate usability of National Adverse Drug Reactions Reporting System. Methods This study was descriptive and cross-sectional.
Marziyhe Meraji +3 more
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Delayed angioedema during therapy with angiotensin-converting enzyme inhibitors [PDF]
Introduction. Angiotensin-converting enzyme inhibitors are leading cause of drug-induced angioedema, with incidence of 0.1 to 0.2%. The angioedema is not of immune nature; in predisposed individuals it is caused by accumulation of vasoactive mediators
Janković Slobodan M. +1 more
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: The U.S. Food and Drug Administration (FDA) has stated that the prescription of remdesivir should be cautious for patients with estimated glomerular filtration rate (eGFR) < 30 and some studies reported risk of adverse renal events.
Nayara Aparecida de Oliveira Silva +3 more
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Awareness of Adverse Drug Reaction Reporting System in General Population [PDF]
Background: Safety of drugs has become a major issue in public healthcare. Spontaneous reporting of adverse drug reaction (ADR) is the cornerstone in management of drug safety. We aimed to investigate the awareness and knowledge of spontaneous ADR re-porting in general public of Korea.Methods: A total of 1,500 study subjects aged 19-69 years were ...
So Hyeon Ahn +4 more
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Combining Social Media and FDA Adverse Event Reporting System to Detect Adverse Drug Reactions [PDF]
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 diversity.
Ying Li, Antonio Jimeno Yepes, Cao Xiao
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