OBJECTIVE Adverse drug reaction (ADR) is one of the major causes of failure in drug development. Severe ADRs that go undetected until the post-marketing phase of a drug often lead to patient morbidity. Accurate prediction of potential ADRs is required in the entire life cycle of a drug, including early stages of drug design, different phases of clinical trials, and post-marketing surveillance. ...

OBJECTIVE With the use of any drug comes the possibility of unintended consequences which when harmful are referred to as adverse drug reactions (ADRs). The development of national pharmacovigilance systems is the responsibility of all health workers. The aim of this study was to investigate the knowledge of nurses about pharmacovigilance and attitudes about ADR and adverse event reporting. M...

OBJECTIVES To identify adverse drug reactions associated with lamotrigine in children and compare the safety profile with other antiepileptic drugs. SETTING Databases EMBASE (1974-April 2015), MEDLINE (1946-April 2015), PubMed and the Cochrane library for randomised controlled trials were searched for studies on safety of lamotrigine. PARTICIPANTS All studies involving paediatric patients a...

Adverse drug reactions (ADRs) present a major concern for drug safety and are a major obstacle in modern drug development. They account for about one-third of all late-stage drug failures, and approximately 4% of all new chemical entities are withdrawn from the market due to severe ADRs. Although off-target drug interactions are considered to be the major causes of ADRs, the adverse reaction pr...

Adverse drug reactions (ADRs) are an important health issue. While prevalence and risk factors associated with ADRs in the general adult population have been well documented, much less is known about ADRs in the elderly population. The aim of this study was to review the published literature to estimate the prevalence of ADRs in the elderly in the acute care setting and identify factors associa...

Drug safety, also known as pharmacovigilance, is defined by the World Health Organization (WHO) as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems” (WHO 2002). How to detect signal of adverse drug reactions (ADRs) has become one important issue of drug safety. In 2000, ADR was defined ...

UNLABELLED The objectives of this study were to learn about the characteristics and rules of the occurrence of adverse reactions caused by lactam antibiotics and provide a reference for clinical drug use. METHODS A retrospective study was made to analyse the 113 case reports of adverse reactions caused by β-lactam antibiotics collected in our hospital between 2007 and 2009. RESULTS 113 case...

to inform healthcare professionals of a rare serious reaction leading to leg amputation following intramuscular injection of iron dextran and report comments for preventing such reactions.a case of leg amputation following intramuscular injection of iron dextran reported to iranian pharmacovigilance center was reviewed. patient and reaction data was collected by assessing the reported yellow ca...