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
doaj +2 more sources
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
openaire +3 more sources
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
openaire +1 more source
A scoping review of the pharmacovigilance systems in west African region [PDF]
Background: Pharmacovigilance is essential for monitoring drug safety and managing adverse drug reactions, particularly in the context of increasing medication use in West Africa. This review aims to assess the existing state of pharmacovigilance systems,
Isatu Jalloh +5 more
doaj +1 more source
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
doaj +1 more source
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
doaj +1 more source
Interactive exploration of population scale pharmacoepidemiology datasets
Population-scale drug prescription data linked with adverse drug reaction (ADR) data supports the fitting of models large enough to detect drug use and ADR patterns that are not detectable using traditional methods on smaller datasets. However, detecting
Abadi M. +4 more
core +1 more source
SIAIP position paper: provocation challenge to antibiotics and non-steroidal anti-inflammatory drugs in children [PDF]
Drug hypersensitivity reactions (DHRs) in childhood are mainly caused by betalactam or non-betalactam antibiotics, and non-steroidal anti-inflammatory drugs (NSAIDs).
Arasi, Stefania +19 more
core +1 more source
Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices [PDF]
A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking ...
Abbott, Ryan, Ayres, Ian
core +3 more sources
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
doaj +1 more source

