Authors' Response to Braillon's Comment on: "Limited Evidence for Risk Factors for Proarrhythmia and Sudden Cardiac Death in Patients Using Antidepressants: Dutch Consensus on ECG Monitoring".

abstract：BACKGROUND:At time of approval, knowledge of the full benefit risk of any drug is limited, in particular with regards to safety. Post-approval surveillance of potential drug safety concerns is recognized as an important task of regulatory agencies. For innovative, often first-in-class drugs, safety knowledge at time of...

journal_title：Drug safety

authors： Mol PG,Arnardottir AH,Motola D,Vrijlandt PJ,Duijnhoven RG,Haaijer-Ruskamp FM,de Graeff PA,Denig P,Straus SM

更新日期：2013-11-01 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：:Propofol (2, 6-diisopropylphenol) is a potent intravenous hypnotic agent that is widely used in adults and children for sedation and the induction and maintenance of anaesthesia. Propofol has gained popularity for its rapid onset and rapid recovery even after prolonged use, and for the neuroprotection conferred. Howev...

journal_title：Drug safety

authors： Fodale V,La Monaca E

更新日期：2008-01-01 00:00:00

abstract：:Several anticancer drugs have been associated with cardiac toxicity, especially the anthracyclines and trastuzumab. The pathogenesis of anthracycline-associated toxicity has been well described, whereas the mechanism of trastuzumab-associated toxicity is unknown. Although routine cardiac imaging studies (e.g. echocard...

journal_title：Drug safety

authors： Sparano JA,Brown DL,Wolff AC

更新日期：2002-01-01 00:00:00

abstract：:The term 'benefit-risk ratio' is often used as a general term linked to the use of a medicine. To balance risk and benefit is, however, a very complex exercise. For most medicines the benefits are limited to a few indications and for an individual patient there is usually only a single benefit sought but the potential...

journal_title：Drug safety

authors： Edwards R,Wiholm BE,Martinez C

更新日期：1996-07-01 00:00:00

abstract：BACKGROUND:Individual case reports of suspected harm from medicines are fundamental for signal detection in postmarketing surveillance. Their effective analysis requires reliable data and one challenge is report duplication. These are multiple unlinked records describing the same suspected adverse drug reaction (ADR) i...

journal_title：Drug safety

authors： Tregunno PM,Fink DB,Fernandez-Fernandez C,Lázaro-Bengoa E,Norén GN

更新日期：2014-04-01 00:00:00

abstract：:Data from basic science and clinical studies suggest that hydroxyurea (hydroxycarbamide)-based regimens are effective treatment options for patients with HIV at various stages of disease. In vitro studies of HIV-infected lymphocytes have shown that hydroxyurea: (i) inhibits viral DNA synthesis; (ii) synergistically in...

journal_title：Drug safety

authors： Lisziewicz J,Foli A,Wainberg M,Lori F

更新日期：2003-01-01 00:00:00

abstract：:Adverse drug reactions (ADRs) cause considerable mortality and morbidity but no recent reviews are currently available for the European region. Therefore, we performed a review of all epidemiological studies quantifying ADRs in a European setting that were published between 1 January 2000 and 3 September 2014. Include...

journal_title：Drug safety

authors： Bouvy JC,De Bruin ML,Koopmanschap MA

更新日期：2015-05-01 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：:Epidural analgesia for caesarean section is increasingly used and is gradually replacing general anaesthesia. Hypotension is one of the main risks: preloading of the maternal circulation is used to prevent maternal hypotension and its consequences. For this, various colloid and crystalloid solutions are used. We repor...

journal_title：Drug safety

authors： Barbier P,Jonville AP,Autret E,Coureau C

更新日期：1992-01-01 00:00:00

abstract：:The electrocardiographic effects of ebastine and its active metabolite, carebastine, have been studied alone and in relevant drug-interaction studies in various patient populations. The overall cardiac tolerability of ebastine is excellent. In ebastine dose-ranging studies in adults and children, there were no meaning...

journal_title：Drug safety

authors： Moss AJ,Morganroth J

更新日期：1999-01-01 00:00:00

abstract：:Causality in pharmacovigilance is a difficult and time consuming exercise. This paper presents the challenges in determining causation by drug therapy. The first is that causation is complex and needs to be viewed from the context of the patient treated, rather than the drug product. Multiple causal vectors should be ...

journal_title：Drug safety

authors： Ralph Edwards I

更新日期：2017-05-01 00:00:00

abstract：BACKGROUND:Hepatic dysfunction, manifested as liver enzyme elevations, occurs frequently in patients who are treated with interferon, however, data for patients with multiple sclerosis are limited. OBJECTIVE:To retrospectively assess the safety profile of interferon-beta-1a therapy with respect to liver function durin...

journal_title：Drug safety

authors： Francis GS,Grumser Y,Alteri E,Micaleff A,O'Brien F,Alsop J,Stam Moraga M,Kaplowitz N

更新日期：2003-01-01 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：:Cytokines are now commonly used in the treatment of many conditions, especially cancer, haematological malignancies and chronic viral hepatitis. With some of these cytokines, clinical induction and/or exacerbation of autoimmune manifestations have been observed. This has been the case with interferon-alpha and interfe...

journal_title：Drug safety

authors： Miossec P

更新日期：1997-08-01 00:00:00

abstract：INTRODUCTION:As asthma medications are frequently prescribed for children, knowledge of the safety of these drugs in the paediatric population is important. Although spontaneous reports cannot be used to prove causality of adverse events, they are important in the detection of safety signals. OBJECTIVE:Our objective w...

journal_title：Drug safety

authors： Baan EJ,de Smet VA,Hoeve CE,Pacurariu AC,Sturkenboom MCJM,de Jongste JC,Janssens HM,Verhamme KMC

更新日期：2020-01-01 00:00:00

abstract：INTRODUCTION:There are few studies assessing how data on adverse drug events from consumers on social media compare with other sources. AIM:The aim of this study was to assess the consistency of adverse event data of statin medications from social media as compared with other sources. METHODS:We collected data on the...

journal_title：Drug safety

authors： Golder S,Smith K,O'Connor K,Gross R,Hennessy S,Gonzalez-Hernandez G

更新日期：2021-02-01 00:00:00

abstract：:Zopiclone is a cyclopyrrolone hypnosedative that is chemically unrelated to the benzodiazepines but nevertheless potentiates gamma-aminobutyric acid-mediated neuronal inhibition, and has demonstrated proven efficacy and good tolerability in the treatment of insomnia over 15 years of use. Zopiclone is indicated for sho...

journal_title：Drug safety

authors： Hajak G

更新日期：1999-12-01 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：: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：BACKGROUND:The use of data mining has increased among regulators and pharmaceutical companies. The incremental value of data mining as an adjunct to traditional pharmacovigilance methods has yet to be demonstrated. Specifically, the utility in identifying new safety signals and the resources required to do so have not ...

journal_title：Drug safety

authors： Bailey S,Singh A,Azadian R,Huber P,Blum M

更新日期：2010-02-01 00:00:00

abstract：:Similar to other beta-lactam antibacterials, carbapenems have a neurotoxic potential that seems to be higher than that of the penicillins and cephalosporins. Seizures have been reported in several large studies of patients treated with imipenem/cilastatin. However, it seems clear that the main factor increasing the ri...

journal_title：Drug safety

authors： Norrby SR

更新日期：1996-08-01 00:00:00

abstract：BACKGROUND:The availability of large-scale observational healthcare data allows for the active monitoring of safety of drugs, but research is needed to determine which statistical methods are best suited for this task. Recently, the Longitudinal Gamma Poisson Shrinker (LGPS) and Longitudinal Evaluation of Observational...

journal_title：Drug safety

authors： Schuemie MJ,Madigan D,Ryan PB

更新日期：2013-10-01 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：:Drugs used in the treatment of peptic ulcer disease may interact with the renal system in a variety of ways. Since many agents are eliminated by renal excretion, clearance of these agents may be reduced and half-life extended in the presence of renal insufficiency. The histamine H2-receptor antagonists may interfere w...

journal_title：Drug safety

authors： Burgess E,Muruve D

更新日期：1992-07-01 00:00:00

abstract：:Although inhaled and intranasal corticosteroids are first-line therapy for asthma and allergic rhinitis, there has recently been an increasing awareness of their propensity to produce systemic adverse effects. The availability of more potent and lipophilic corticosteroids and new chlorofluorocarbon (CFC)-free formulat...

journal_title：Drug safety

authors： Lipworth BJ,Jackson CM

更新日期：2000-07-01 00:00:00

abstract：:Many drug products contain excipients which perform important functions in terms of stability, solubility and identification. Excipients should not be considered as inactive ingredients, as they have been associated with a wide range of adverse reactions in some individuals. Monitoring for excipient toxicity is import...

journal_title：Drug safety

authors： Scott AW

更新日期：1990-01-01 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：:The non-vitamin K antagonist oral anticoagulants (NOACs) are used for thromboembolic prophylaxis of patients with atrial fibrillation and in the treatment as well as secondary prophylaxis of patients with venous thromboembolism. Even though NOACs have a better safety profile than vitamin K antagonists (VKAs), there wi...

journal_title：Drug safety

authors： Husted S,Verheugt FW,Comuth WJ

更新日期：2016-01-01 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