Results 31 to 40 of about 5,950 (190)

Possible adverse drug events leading to hospital admission in a Brazilian teaching hospital

Clinics, 2014
OBJECTIVES: Drug safety problems can lead to hospital admission. In Brazil, the prevalence of hospitalization due to adverse drug events is unknown. This study aims to estimate the prevalence of hospitalization due to adverse drug events and to identify ...
Fabiana Rossi Varallo, Helaine Carneiro Capucho, Cleópatra da Silva Planeta, Patrícia de Carvalho Mastroianni   +3 more
doaj   +1 more source

Enhancing Postmarketing Surveillance of Medical Products With Large Language Models

JAMA Network Open
ImportanceThe Sentinel System is a key component of the US Food and Drug Administration (FDA) postmarketing safety surveillance commitment and uses clinical health care data to conduct analyses to inform drug labeling and safety communications, FDA advisory committee meetings, and other regulatory decisions.
Michael E, Matheny, Jie, Yang, Joshua C, Smith, Colin G, Walsh, Mohammed A, Al-Garadi, Sharon E, Davis, Keith A, Marsolo, Daniel, Fabbri, Ruth R, Reeves, Kevin B, Johnson, Gerald J, Dal Pan, Robert, Ball, Rishi J, Desai   +12 more
openaire   +2 more sources

Rationale and design of PATRO Adults, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope for the treatment of adult patients with growth hormone deficiency

Therapeutic Advances in Endocrinology and Metabolism, 2012
Objective : To describe the rationale and design of PATRO Adults, a postmarketing surveillance study of the long-term efficacy and safety of somatropin (Omnitrope ® ) for the treatment of adult patients with growth hormone deficiency (GHD).
Paolo Beck-Peccoz, Francesco Minuto, Alfonso Leal-Cerro, Markus Zabransky, Günter Stalla   +4 more
doaj   +1 more source

Safety and Effectiveness of Dulaglutide in the Treatment of Type 2 Diabetes Mellitus: A Korean Real-World Post-Marketing Study [PDF]

Diabetes & Metabolism Journal
Background To investigate the real-world safety and effectiveness of dulaglutide in Korean adults with type 2 diabetes mellitus (T2DM). Methods This was a real-world, prospective, non-interventional post-marketing safety study conducted from May 26, 2015
Jeonghee Han, Woo Je Lee, Kyu Yeon Hur, Jae Hyoung Cho, Byung Wan Lee, Cheol-Young Park   +5 more
doaj   +1 more source

Improving the Postmarket Surveillance of Total Joint Arthroplasty Devices [PDF]

, 2011
Objective: To evaluate the FDA’s approval process and postmarket surveillance strategies for THR devices. Design: The FDA Center for Devices and Radiological Health (CDRH) 510k releasable database was used to document approved THR devices.
Brennan, Troyen Anthony, Liang, Matthew Heng, Mahomed, Nizar N, Sledge, Clement Blount, Syed, Khalid   +4 more
core   +1 more source

Exposure‐adjusted safety and efficacy of GLP‐I and GLP‐1/GIP receptor agonists compared with non‐GLP‐I for weight management and type 2 diabetes: Based on FDA medical and statistical reports of 34 280 safety and 36 312 efficacy subjects

British Journal of Clinical Pharmacology, EarlyView.
Aims This work aimed to contextualize glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) and glucose‐dependent insulinotropic polypeptide (GIP) receptor agonists safety and efficacy regarding weight management (WM); we analysed Food and Drug Administration (FDA) Medical Reviews to analyse 14 medications using patient‐exposure year normalization and ...
Aishwarya Prasad, Anshu Arora, Arun Arora, Jeena Vaid, Arif Khan   +4 more
wiley   +1 more source

Practice, knowledge and attitude of physicians and pharmacists towards the spontaneous reporting system of adverse drug reactions in Switzerland

British Journal of Clinical Pharmacology, EarlyView.
Introduction Introduction Reporting adverse drug reactions (ADRs) is essential for detecting drug risks. Despite legal obligations in Switzerland, underreporting remains an issue. This study assessed practice, knowledge and attitudes towards the spontaneous ADR reporting system among physicians and pharmacists.
Fiona A. Strobel, Thomas Stammschulte, Patrick E. Beeler   +2 more
wiley   +1 more source

MDDC: An R and Python package for adverse event identification in pharmacovigilance data

Scientific Reports
The safety of medical products continues to be a significant health concern worldwide. Spontaneous reporting systems (SRS) and pharmacovigilance databases are essential tools for postmarketing surveillance of medical products.
Anran Liu, Raktim Mukhopadhyay, Marianthi Markatou   +2 more
doaj   +1 more source

Improving Drug Safety: The Importance of Postmarking Drug Surveillance [PDF]

, 2004
Improved postmarketing surveillance system may reduce the number of adverse reactions to prescription drugs that under the current system continue to rise as the number of prescriptions written in the U.S ...
James Nyberg, Robert N. Butler
core  

Safety of opioid patch initiation in Australian residential aged care [PDF]

, 2015
Explores opioid use by aged care facility residents before and after initiation of transdermal opioid patches. Abstract Objective: To explore opioid use by aged care facility residents before and after initiation of transdermal opioid patches. Design:
Elizabeth Roughead, Lisa Pont, Svetla Gadzhanova   +2 more
core   +1 more source