A Comparative View of Reported Adverse Effects of Statins in Social Media, Regulatory Data, Drug Information Databases and Systematic Reviews.

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

abstract：:Thallium poisoning seldom occurs in Spain. This article reports 5 cases of thallium poisoning, of which 4 of the patients belonged to the same family. The cases occurred in or near Granada between 1985 and 1987. The symptoms were initially gastrointestinal (vomiting, abdominal pain, gastrointestinal haemorrhage, etc.)...

journal_title：Drug safety

authors： Villanueva E,Hernandez-Cueto C,Lachica E,Rodrigo MD,Ramos V

更新日期：1990-09-01 00:00:00

abstract：:Antibiotic-associated pseudomembranous colitis is an uncommon but potentially serious adverse reaction, resulting in acute diarrhoea and characterised by colonic pseudomembranes. A direct relationship between the disease, recent antibiotic therapy and proliferation of Clostridium difficile in the colonic lumen was est...

journal_title：Drug safety

authors： Andréjak M,Schmit JL,Tondriaux A

更新日期：1991-09-01 00:00:00

abstract：:Pharmacotherapy in pregnant women is often necessary to treat chronic or relapsing depression or anxiety disorders. Studies that have evaluated the safety of selective serotonin reuptake inhibitors (SSRIs) in early pregnancy have not shown an enhanced risk of major congenital malformations and these results may have c...

journal_title：Drug safety

authors： Nordeng H,Spigset O

更新日期：2005-07-01 00:00:00

abstract：INTRODUCTION AND OBJECTIVE:Pharmacovigilance requirements for biologics mandate that EU Member States shall ensure that any biologic that is the subject of a suspected adverse drug reaction (ADR) is identifiable by brand name and batch number. Recent studies showed that brand name identification is well established, wh...

journal_title：Drug safety

authors： Klein K,Scholl JH,Vermeer NS,Broekmans AW,Van Puijenbroek EP,De Bruin ML,Stolk P

更新日期：2016-02-01 00:00:00

abstract：:The introduction of MedDRA, the Medical Dictionary for Regulatory Activities, as a standardised terminology may have a major impact on the performance of risk management. Thus, MedDRA is likely to have an important effect on the analysis of clinical trial safety data. Review of the most commonly used terms in clinical...

journal_title：Drug safety

authors： Brown EG

更新日期：2004-01-01 00:00:00

abstract：BACKGROUND:Rituximab is a monoclonal antibody approved for treating CD20-positive B-cell non-Hodgkin's lymphoma and rheumatoid arthritis but is used off-label for treating many autoimmune disorders, including multiple sclerosis (MS). Similarly to other monoclonal antibodies, the incidence of infusion-related reactions ...

journal_title：Drug safety

authors： Brown BA,Torabi M

更新日期：2011-02-01 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：:The article vigiGrade: A Tool to Identify Well-Documented Individual Case Reports and Highlight Systematic Data Quality Issues, written by Tomas Bergvall. G. Niklas Norén. Marie Lindquist, was originally published Online First without open access. ...

journal_title：Drug safety

authors： Bergvall T,Norén GN,Lindquist M

更新日期：2019-06-01 00:00:00

abstract：INTRODUCTION:Pharmacovigilance, the monitoring of drug safety after marketing approval, highly depends on the adequate reporting of adverse drug reactions (ADRs). To improve pharmacovigilance awareness and future ADR reporting among medical students, we developed and evaluated a student-run pharmacovigilance programme....

journal_title：Drug safety

authors： Schutte T,Tichelaar J,Reumerman MO,van Eekeren R,Rolfes L,van Puijenbroek EP,Richir MC,van Agtmael MA

更新日期：2017-05-01 00:00:00

abstract：:The biochemistry of vitamin K metabolism and the role of vitamin K-dependent gamma-carboxylation of the vitamin K-dependent coagulation factors are now well understood. Likewise, there is a clear understanding of the role of oral anticoagulants in the inhibition of these coagulation factors. However, the effect of ora...

journal_title：Drug safety

authors： Pineo GF,Hull RD

更新日期：1993-10-01 00:00:00

abstract：:Orally administered levodopa remains the most effective symptomatic treatment for Parkinson's disease. The introduction of levodopa therapy is often delayed, however, because of the fear that it might be toxic for the remaining dopaminergic neurons, and thus accelerate the deterioration of the patient's condition. Evi...

journal_title：Drug safety

authors： Murer MG,Raisman-Vozari R,Gershanik O

更新日期：1999-11-01 00:00:00

abstract：:After 2002, an association between stroke and antipsychotic use was reported in clinical trials and large database studies. This review considers previous quantitative reviews, newly published clinical trials, and recent observational cohort and case-control studies, and focuses on the clinical significance of the ris...

journal_title：Drug safety

authors： Sacchetti E,Turrina C,Valsecchi P

更新日期：2010-04-01 00:00:00

abstract：BACKGROUND:Clozapine is an antipsychotic medication associated with a lower suicide rate compared with other antipsychotic agents. Clozapine is used specifically in patients for whom previous therapy was inadequate or not tolerated, and is the only antipsychotic agent associated with the development of myocarditis. OB...

journal_title：Drug safety

authors： Haas SJ,Hill R,Krum H,Liew D,Tonkin A,Demos L,Stephan K,McNeil J

更新日期：2007-01-01 00:00:00

abstract：:Monobactams and carbapenems are 2 classes of beta-lactam antibiotics that were introduced in the 1980s. This review considers the monobactam aztreonam and the carbapenems imipenem and meropenem. Imipenem is administered together with cilastatin, which inhibits the enzymatic breakdown of imipenem in the kidney. The ant...

journal_title：Drug safety

authors： Alván G,Nord CE

更新日期：1995-05-01 00:00:00

abstract：: ...

journal_title：Drug safety

authors： Kawada T

更新日期：2018-06-01 00:00:00

abstract：INTRODUCTION:Detecting signals of safety concerns associated with complementary medicines (CMs) relies on spontaneous reports submitted by health professionals and patients/consumers. Community pharmacists are well placed to identify and report suspected adverse drug reactions (ADRs) associated with CMs, but pharmacist...

journal_title：Drug safety

authors： Barnes J,Butler R

更新日期：2020-11-01 00:00:00

abstract：:Aspirin (acetylsalicylic acid) and other nonsteroidal anti-inflammatory drugs (NSAIDs) cause deterioration in respiratory function in approximately 10% of adults with asthma and a smaller proportion of children with asthma. We propose evidence-based guidelines for the safe use of NSAIDs in individuals with asthma foll...

journal_title：Drug safety

authors： Levy S,Volans G

更新日期：2001-01-01 00:00:00

abstract：:The mitochondrial respiratory chain (MRC) and ATP synthase (complex V) play an essential role in cellular energy production by the process of oxidative phosphorylation. In addition to inborn errors of metabolism, as well as secondary causes from disease pathophysiology, an impairment of oxidative phosphorylation can r...

journal_title：Drug safety

authors： Hargreaves IP,Al Shahrani M,Wainwright L,Heales SJ

更新日期：2016-07-01 00:00:00

abstract：BACKGROUND:Macrolides are a group of commonly prescribed antibiotics. There is some doubt surrounding the use of the newer macrolides in pregnancy. OBJECTIVE:The present study aimed to compare outcomes of pregnancies exposed to the new macrolides clarithromycin, azithromycin and roxithromycin with non-teratogenic prep...

journal_title：Drug safety

authors： Bar-Oz B,Weber-Schoendorfer C,Berlin M,Clementi M,Di Gianantonio E,de Vries L,De Santis M,Merlob P,Stahl B,Eleftheriou G,Maňáková E,Hubičková-Heringová L,Youngster I,Berkovitch M

更新日期：2012-07-01 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：:The aim of this review is to analyse and summarise the literature data about the incidence of weight gain in patients exposed to atypical antipsychotics during long-term (>or=1 year) treatment regimens. Despite the clinical relevance of the topic, the vast majority of reviewed studies showed methodological limitations...

journal_title：Drug safety

authors： Gentile S

更新日期：2006-01-01 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：BACKGROUND:Over-the-counter analgesics (OTCAs), principally paracetamol (acetaminophen)-containing compounds and NSAIDs, are commonly used medications. Guidelines for the use of these agents in patients with chronic liver disease (CLD) are not available, despite the possibility that such patients may be more susceptibl...

journal_title：Drug safety

authors： Rossi S,Assis DN,Awsare M,Brunner M,Skole K,Rai J,Andrel J,Herrine SK,Reddy RK,Navarro VJ

更新日期：2008-01-01 00:00:00

abstract：:While classifications into generations according to antimicrobial activity has helped clinicians incorporate the increasing number of cephalosporins into their pharmacological repertoire, adverse effects among the different agents fail to follow similar categories. In general, cephalosporins are fairly well tolerated ...

journal_title：Drug safety

authors： Thompson JW,Jacobs RF

更新日期：1993-08-01 00:00:00

abstract：BACKGROUND:Following reports of sudden death in patients taking medication to treat attention-deficit hyperactivity disorder (ADHD), this study aimed to identify cases of death in patients prescribed stimulants and atomoxetine and to determine any association between these and sudden death. METHOD:The UK General Pract...

journal_title：Drug safety

authors： McCarthy S,Cranswick N,Potts L,Taylor E,Wong IC

更新日期：2009-01-01 00:00:00

abstract：:In general, the selective estrogen receptor modulators (SERMs) currently indicated for the treatment and prevention of breast cancer, i.e. tamoxifen and toremifene, are fairly well tolerated. However, tamoxifen has been shown to induce hepatocellular carcinomas in rats, but not in humans, and can increase the risk of ...

journal_title：Drug safety

authors： Curtis MG

更新日期：2001-01-01 00:00:00

abstract：:Histone deacetylases (HDACs) are expressed at increased levels in cells of various malignancies, and the use of HDAC inhibitors has improved outcomes in patients with haematological malignancies (T-cell lymphomas and multiple myeloma). However, they are not as effective in solid tumours. Five agents are currently appr...

journal_title：Drug safety

authors： Shah RR

更新日期：2019-02-01 00:00:00

abstract：INTRODUCTION:One-third of adults in the USA experience chronic pain and use a variety of painkillers, such as nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and opioids. However, some serious adverse events (AEs), such as cardiovascular incidents, overdose, and death, have been found to be related to pai...

journal_title：Drug safety

authors： Min J,Osborne V,Kowalski A,Prosperi M

更新日期：2018-03-01 00:00:00

abstract：:Since the introduction of the interferons in the 1990s, a multitude of different immunomodulatory and immunosuppressant disease-modifying therapies for multiple sclerosis (MS) have been developed. They have all shown positive effects on clinical endpoints such as relapse rate and disease progression and are a heteroge...

journal_title：Drug safety

authors： Förster M,Küry P,Aktas O,Warnke C,Havla J,Hohlfeld R,Mares J,Hartung HP,Kremer D

更新日期：2019-05-01 00:00:00