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https://www.readbyqxmd.com/read/27855534/campania-preventability-assessment-committee-a-focus-on-the-preventability-of-the-contrast-media-adverse-drug-reactions
#1
Maurizio Sessa, Claudia Rossi, Concetta Rafaniello, Annamaria Mascolo, Daniela Cimmaruta, Cristina Scavone, Sonia Fiorentino, Enrico Grassi, Alfonso Reginelli, Antonio Rotondo, Liberata Sportiello
OBJECTIVE: The current study aims to assess the preventability of the contrast media adverse drug reactions reported through the Campania spontaneous reporting system, identifying the possible limitations emerged in this type of evaluation. METHOD: All the individual case safety reports validated by the Campania Pharmacovigilance Regional Centre from July 2012 to September 2015 were screened to select those that reported contrast media as suspected drug. Campania Preventability Assessment Committee, in collaboration with clinicians specialized in Radiology, assessed the preventability according to the P-Method, through a case-by-case approach...
November 18, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27292007/prevention-and-management-of-adverse-reactions-induced-by-iodinated-contrast-media
#2
Yi Wei Wu, Kheng Song Leow, Yujin Zhu, Cher Heng Tan
Iodinated radiocontrast media (IRCM) is widely used in current clinical practice. Although IRCM is generally safe, serious adverse drug reactions (ADRs) may still occur. IRCM-induced ADRs may be subdivided into chemotoxic and hypersensitivity reactions. Several factors have been shown to be associated with an increased risk of ADRs, including previous contrast media reactions, history of asthma and allergic disease, etc. Contrast media with lower osmolality is generally recommended for at-risk patients to prevent ADRs...
April 2016: Annals of the Academy of Medicine, Singapore
https://www.readbyqxmd.com/read/27134522/comparison-of-iohexol-380-and-iohexol-350-for-coronary-ct-angiography-a-multicenter-randomized-double-blind-phase-3-trial
#3
Eun-Ah Park, Whal Lee, Doo Kyoung Kang, Sung Jin Kim, Young-Ju Kim, Yookyung Kim, Yon Mi Sung, Soon-Young Song, Yu-Whan Oh, Hwan Seok Yong, Heon Lee, Eui-Yong Jeon, Gong-Yong Jin, Byoung Wook Choi, Sang-Il Choi
OBJECTIVE: This multi-center, randomized, double-blind, phase 3 trial was conducted to compare the safety and efficacy of contrast agents iohexol-380 and iohexol-350 for coronary CT angiography in healthy subjects. MATERIALS AND METHODS: Volunteers were randomized to receive 420 mgI/kg of either iohexol-350 or iohexol-380 using a flow rate of 4 mL/sec. All adverse events were recorded. Two blinded readers independently reviewed the CT images and conflicting results were resolved by a third reader...
May 2016: Korean Journal of Radiology: Official Journal of the Korean Radiological Society
https://www.readbyqxmd.com/read/27015204/the-incidence-classification-and-management-of-acute-adverse-reactions-to-the-low-osmolar-iodinated-contrast-media-isovue-and-ultravist-in-contrast-enhanced-computed-tomography-scanning
#4
Bin Zhang, Yuhao Dong, Long Liang, Zhouyang Lian, Jing Liu, Xiaoning Luo, Wenbo Chen, Xinyu Li, Changhong Liang, Shuixing Zhang
Some epidemiologic surveillance studies have recorded adverse drug reactions to radiocontrast agents. We aimed to investigate the incidence and management of acute adverse reactions (AARs) to Ultravist-370 and Isovue-370 in patients who underwent contrast-enhanced computed tomography (CT) scanning.Data from 137,473 patients were analyzed. They had undergone enhanced CT scanning with intravenous injection of Ultravist-370 or Isovue-370 during the period of January 1, 2006 to December 31, 2012 in our hospital...
March 2016: Medicine (Baltimore)
https://www.readbyqxmd.com/read/26960538/safety-of-gadobutrol-in-over-23-000-patients-the-gardian-study-a-global-multicentre-prospective-non-interventional-study
#5
Martin R Prince, Hae Giu Lee, Chang-Hee Lee, Sung Won Youn, In Ho Lee, Woong Yoon, Benqiang Yang, Haiping Wang, Jin Wang, Tiffany Ting-Fang Shih, Guo-Shu Huang, Jiing-Feng Lirng, Petra Palkowitsch
OBJECTIVES: To investigate the safety and tolerability of gadobutrol at the recommended dose in patients requiring contrast-enhanced magnetic resonance imaging/angiography (MRI/MRA) in the routine setting. METHODS: GARDIAN prospectively enrolled 23,708 patients undergoing routine gadobutrol-enhanced MRI/MRA for approved indications at 272 study centres in Europe, Asia, North America, and Africa and monitored for adverse events. RESULTS: Median gadobutrol dose was 0...
January 2017: European Radiology
https://www.readbyqxmd.com/read/26544039/differences-between-drug-induced-and-contrast-media-induced-adverse-reactions-based-on-spontaneously-reported-adverse-drug-reactions
#6
COMPARATIVE STUDY
JiHyeon Ryu, HeeYoung Lee, JinUk Suh, MyungSuk Yang, WonKu Kang, EunYoung Kim
OBJECTIVE: We analyzed differences between spontaneously reported drug-induced (not including contrast media) and contrast media-induced adverse reactions. METHODS: Adverse drug reactions reported by an in-hospital pharmacovigilance center (St. Mary's teaching hospital, Daejeon, Korea) from 2010-2012 were classified as drug-induced or contrast media-induced. Clinical patterns, frequency, causality, severity, Schumock and Thornton's preventability, and type A/B reactions were recorded...
2015: PloS One
https://www.readbyqxmd.com/read/26246330/incidence-of-adverse-cutaneous-drug-reactions-in-22-866-chinese-inpatients-a-prospective-study
#7
Xiao-Yin Tian, Bing Liu, Hao Shi, Zi-Ran Zhao, Xi-Ping Zhou, Tao Zhang, Qiu-Ning Sun, Ya-Gang Zuo
Cutaneous adverse drug reactions (ADRs) are common. However, no prospective study assessing cutaneous ADRs is available for Chinese populations. This study aimed to assess the incidence, manifestations, causative drugs, and other factors related to cutaneous ADRs. A total of 22,866 inpatients were surveyed prospectively from January to April 2012 at the Peking Union Medical College Hospital. Only cutaneous ADRs induced by systemic drugs were considered. Fifty cases were confirmed as cutaneous ADRs, for an estimated incidence of 2...
November 2015: Archives of Dermatological Research
https://www.readbyqxmd.com/read/26156557/suspected-adverse-reactions-to-contrast-media-in-campania-region-italy-results-from-14-years-of-post-marketing-surveillance
#8
Maurizio Sessa, Claudia Rossi, Annamaria Mascolo, Enrico Grassi, Sonia Fiorentino, Cristina Scavone, Alfonso Reginelli, Antonio Rotondo, Liberata Sportiello
OBJECTIVE: During the last years in Italy, contrast media (CM) use increased. An increase of monitoring activities on CM-induced adverse drug reaction (ADR) is necessary, also in our regional territory. The main aim of this study was to give a preliminary evaluation of all Spontaneous Reports of ADRs (SRA) attributed to CM sent to Campania Pharmacovigilance Regional Center (CRFVC) from 01 January 2001 to 31 October 2014. RESEARCH DESIGN AND METHODS: For each SRA we evaluated: frequency and source, ADRs onset (time to event, seriousness and outcome), socio-demographic characteristics and risk factors of cases, the most reported CM (checking for pharmacodynamic and pharmacokinetic interactions)...
2015: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/26058857/safety-and-tolerability-of-iopromide-in-patients-undergoing-cardiac-catheterization-real-world-multicenter-experience-with-17-513-patients-from-the-trust-trial
#9
MULTICENTER STUDY
Ji-Yan Chen, Yong Liu, Ying-Ling Zhou, Ning Tan, Bin Zhang, Ping-Yan Chen, Li-Bing Chen
To assess the incidence of and risk factors for acute adverse drug reactions (ADRs) (occurring within 1 h) following iopromide administration in cardiac catheterization in Chinese 'real-world' practice. Acute ADRs following iopromide administration during coronary angiography or percutaneous coronary intervention (PCI) have not been systematically evaluated in China. TRUST was a prospective, multicenter, observational study conducted at 63 centers in China. Patients received iopromide (300 or 370 mgI/mL) during coronary angiography or PCI (n = 17,513)...
October 2015: International Journal of Cardiovascular Imaging
https://www.readbyqxmd.com/read/25933719/gadobutrol-for-contrast-enhanced-magnetic-resonance-imaging-in-elderly-patients-review-of-the-safety-profile-from-clinical-trial-post-marketing-surveillance-and-pharmacovigilance-data
#10
MULTICENTER STUDY
J Endrikat, C Schwenke, M R Prince
AIM: To assess the safety of gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18-64 years. MATERIALS AND METHODS: Safety data on gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases...
July 2015: Clinical Radiology
https://www.readbyqxmd.com/read/25643844/safety-of-gadoxetate-disodium-results-from-the-clinical-phase-ii-iii-development-program-and-postmarketing-surveillance
#11
Jan S Endrikat, Susan Dohanish, Thomas Balzer, Josy A M Breuer
PURPOSE: To summarize the safety data of gadoxetate disodium, reported in 12 Phase II and III clinical development studies and in the postmarketing surveillance database. MATERIALS AND METHODS: Patients with liver lesions received gadoxetate disodium-enhanced liver magnetic resonance imaging (MRI). Adverse events (AEs) were recorded and evaluated with regard to a potential drug relationship. Subgroup analyses were run on patients with special medical history. Worldwide spontaneous AEs and adverse drug reactions (ADRs) from postmarketing safety surveillance were analyzed...
September 2015: Journal of Magnetic Resonance Imaging: JMRI
https://www.readbyqxmd.com/read/25626627/adverse-allergic-reactions-to-linear-ionic-gadolinium-based-contrast-agents-experience-with-194-400-injections
#12
S Aran, K W Shaqdan, H H Abujudeh
AIM: To report the authors' experience with the administration of four gadolinium-based contrast agents (GBCA; gadopentetate dimeglumine, gadofosveset trisodium, gadoxetate disodium and gadobenate dimeglumine) in a large study population at a single, large academic medical centre. MATERIALS AND METHODS: The institutional review board approved this retrospective study in which data in the electronic incident reporting system were searched. A total of 194, 400 intravenous administrations of linear ionic GBCAs were assessed for the incidence of adverse reactions and risk factors from 1 January 2007 to 14 January 2014...
May 2015: Clinical Radiology
https://www.readbyqxmd.com/read/25582519/clinical-observation-of-the-adverse-drug-reactions-caused-by-non-ionic-iodinated-contrast-media-results-from-109-255-cases-who-underwent-enhanced-ct-examination-in-chongqing-china
#13
X Li, J Chen, L Zhang, H Liu, S Wang, X Chen, J Fang, S Wang, W Zhang
OBJECTIVE: To analyse the pattern and factors that influence the incidence of adverse drug reactions (ADRs) induced by non-ionic iodinated contrast media and to evaluate their safety profiles. METHODS: Data from 109,255 cases who underwent enhanced CT examination from 1 January 2008 to 31 August 2013 were analysed. ADRs were classified according to the criteria issued by the American College of Radiology and the Chinese Society of Radiology. RESULTS: A total of 375 (0...
March 2015: British Journal of Radiology
https://www.readbyqxmd.com/read/25508307/an-analysis-of-adverse-drug-reactions-to-radiographic-contrast-media-reported-during-a-3-year-period-in-a-tertiary-care-hospital-in-south-india
#14
A Subathra, S Sandhiya, R Kesavan
AIM: The aim of this study was to analyse the nature and incidence of adverse drug reactions to radiographic contrast media (ionic and non ionic) reported during a 3 year period in a tertiary care hospital in South India METHODS: Adverse Drug Reactions (ADRs) to radiographic contrast media (ionic and non ionic) reported during a 3 year period to the pharmacovigilance centre, JIPMER, Pondicherry were retrospectively analysed for demographic profile, frequency, severity, causality and the temporal relationship of contrast administratior to the occurrence of ADR...
January 2014: Indian Journal of Physiology and Pharmacology
https://www.readbyqxmd.com/read/25464676/an-analysis-of-adverse-drug-reactions-to-radiographic-contrast-media-reported-during-a-3-year-period-in-a-tertiary-care-hospital-in-south-india
#15
A Subathra, S Sandhiya, R Kesavan
AIM: The aim of this study was to analyse the nature and incidence of adverse drug reactions to radiographic contrast media (ionic and non ionic) reported during a 3 year period in a tertiary care hospital in South India METHODS: Adverse Drug Reactions (ADRs) to radiographic contrast media (ionic and non ionic) reported during a 3 year period to the pharmacovigilance centre, JIPMER, Pondicherry were retrospectively analysed for demographic profile, frequency, severity, causality and the temporal relationship of contrast administratior to the occurrence of ADR...
January 2014: Indian Journal of Physiology and Pharmacology
https://www.readbyqxmd.com/read/25458866/-cutaneous-adverse-drug-reactions
#16
B Lebrun-Vignes, L Valeyrie-Allanore
Cutaneous adverse drug reactions (CADR) represent a heterogeneous field including various clinical patterns without specific features suggesting drug causality. Exanthematous eruptions, urticaria and vasculitis are the most common forms of CADR. Fixed eruption is uncommon in western countries. Serious reactions (fatal outcome, sequelae) represent 2% of CADR: bullous reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), DRESS (drug reaction with eosinophilia and systemic symptoms or drug-induced hypersensitivity syndrome) and acute generalized exanthematous pustulosis (AGEP)...
April 2015: La Revue de Médecine Interne
https://www.readbyqxmd.com/read/25085041/adverse-reactions-to-contrast-media-an-analysis-of-spontaneous-reports-in-the-database-of-the-pharmacovigilance-programme-of-india
#17
Vivekanandan Kalaiselvan, Surbhi Sharma, Gyanendra Nath Singh
BACKGROUND: Contrast media are used widely to improve medical imaging. Like all other pharmaceuticals, these agents are not completely devoid of risk, and continuous monitoring of adverse reactions with these agents is important. Spontaneous reporting is the simplest method for understanding the safety profile of pharmaceutical products after their approval. OBJECTIVE: Our objective was to identify the pattern and characteristics of adverse reactions attributed to contrast media in the Indian population reported to the National Coordination Centre for the Pharmacovigilance Programme of India (NCC-PvPI)...
September 2014: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/24729407/post-marketing-surveillance-of-the-safety-profile-of-iodixanol-in-the-outpatient-ct-setting-a-prospective-multicenter-observational-study-of-patient-risk-factors-adverse-reactions-and-preventive-measures-in-9953-patients
#18
MULTICENTER STUDY
F H H Müller
PURPOSE: Non-interventional study in outpatient, contrast-enhanced CT; 1. to determine the extent of preventive measures for risk reduction of adverse drug reactions after contrast-enhanced CT examinations. 2. to prospectively determine the incidence and severity of adverse drug reactions occurring after administration of the iso-osmolar contrast medium iodixanol. 3. to determine a possible influence of preventive measures on the incidence/severity of adverse drug reactions.. MATERIALS AND METHODS: Evaluable documentation was provided for 9953 patients from 66 radiology centers across Germany...
November 2014: RöFo: Fortschritte Auf Dem Gebiete der Röntgenstrahlen und der Nuklearmedizin
https://www.readbyqxmd.com/read/24677227/complications-of-radiologic-contrast-in-patients-with-myasthenia-gravis
#19
Mehyar Mehrizi, Robert M Pascuzzi
Use of older contrast agents during radiologic imaging in patients with myasthenia gravis (MG) has been associated with increased myasthenic symptoms and adverse drug reactions (ADRs). The effects of newer contrast agents have not been determined. A retrospective review of imaging safety in MG was conducted. Three hundred fifty-four imaging studies were analyzed. Procedures included 189 computed tomography (CT) images with and 106 without intravenous (IV) contrast and 42 magnetic resonance images (MRIs) with and 17 without contrast...
September 2014: Muscle & Nerve
https://www.readbyqxmd.com/read/24660739/efficacy-of-sonazoid-perflubutane-for-contrast-enhanced-ultrasound-in-the-differentiation-of-focal-breast-lesions-phase-3-multicenter-clinical-trial
#20
MULTICENTER STUDY
Yukio Miyamoto, Toshikazu Ito, Etsuo Takada, Kiyoka Omoto, Toshiko Hirai, Fuminori Moriyasu
OBJECTIVE: The objective of our study was to compare the efficacy of contrast-enhanced ultrasound (CEUS) using the ultrasound contrast agent Sonazoid (perflubutane) with unenhanced ultrasound and supplementary contrast-enhanced MRI in the differential diagnosis (benign vs malignant) of focal breast lesions. The safety of Sonazoid was also assessed in this study. SUBJECTS AND METHODS: A total of 127 patients with focal breast lesions were enrolled in this study at five centers in Japan...
April 2014: AJR. American Journal of Roentgenology
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