Results 1 to 10 of about 27,419 (207)

2024 update on postmarketing nutrivigilance safety profile: a line of dietary food supplements containing red yeast rice for dyslipidemia [PDF]

Archives of Medical Science
Introduction Considering lack of a European standardized postmarketing food supplement surveillance system (nutrivigilance), some member states and companies have developed their own approaches to monitoring potential adverse reactions (AEs) to secure a ...
Maciej Banach, Niki Katsiki, Gustavs Latkovskis, Dan Gaita, Carlos Escobar, Daniel Pella, Peter E. Penson, Federica Fogacci, Zeljko Reiner, Arrigo F.G. Cicero   +9 more
doaj   +4 more sources

Severe Gastrointestinal Toxicity Following the Use of Gilteritinib: A Case Series and Analysis of Postmarketing Surveillance Data

Healthcare, 2023
Gilteritinib has been approved as monotherapy in adults with acute myeloid leukemia (AML) FLT3 mutated with relapsed or refractory disease, in light of its advantages in terms of survival and the favorable safety profile.
L. Gozzo, A. Nardo, Serena B. Brancati, Antongiulio Judica, A. Duminuco, C. Maugeri, M. Parisi, L. Longo, D. Vitale, Rosy Ruscica, G. Romano, E. Mauro, P. Fiumara, G. Palumbo, F. Di Raimondo, C. Vetro, F. Drago   +16 more
semanticscholar   +2 more sources

Postmarketing Surveillance for "Modified-Risk" Tobacco Products [PDF]

Nicotine & Tobacco Research, 2011
The U.S. Food and Drug Administration (FDA) acquired authority to regulate tobacco products in 2009. This authority will provide a structured process for manufacturers to introduce products that may have "modified-risk" for morbidity or mortality relative to traditional tobacco products, with postmarketing surveillance and studies a condition of ...
R. O’Connor
openaire   +3 more sources

Postmarket surveillance: a review on key aspects and measures on the effective functioning in the context of the United Kingdom and Canada

Therapeutic Advances in Drug Safety, 2019
Regulatory approvals for the marketing of medicinal products authorize medical practitioners to prescribe drugs to a group of patients that are defined within the license of the medicinal product.
Nikhil Raj, Swapnil Fernandes, Narayana R. Charyulu, Akhilesh Dubey, Ravi G. S., Srinivas Hebbar   +5 more
doaj   +2 more sources

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   +3 more sources

Serious Infection in Crohn's Disease Patients Treated With Ustekinumab: US Food and Drug Administration Active Postmarket Risk Identification and Analysis in the Sentinel Initiative. [PDF]

Clin Pharmacol Ther
The U.S. Food and Drug Administration (FDA) used an Active Postmarket Risk Identification and Analysis (ARIA) system to address a safety issue (serious infection) identified during clinical review of an application to market ustekinumab as a treatment for Crohn's disease (CD). FDA used an active‐comparator new‐user cohort design, data from six Sentinel
Weissfeld JL, Iyer GS, Seo SC, Giffin A, Simon AL, Kluberg SA, Hoffman ER, Jones JT, Dutcher SK, Korvick JA.   +9 more
europepmc   +2 more sources

Postmarketing Surveillance of Full Spectrum Hemp Extract CBD Products: Reported Adverse Events and Serious Adverse Events. [PDF]

Drugs Real World Outcomes
There is a growing interest in products featuring hemp extracts and a demand for more data regarding their safety. To date, there is a paucity of published data on the safety of these products.A retrospective analysis of postmarketing surveillance data collected in the United States on full spectrum hemp extract (FSHE) products manufactured by ...
Kingsbury CM, Zvorsky I, Spelman K.
europepmc   +4 more sources

The Role of Pharmacovigilance Database in Identifying Antibiotic Resistance and Inappropriate Use: An Analysis of VigiBase Reports From Lower-Middle-Income Countries. [PDF]

Pharmacoepidemiol Drug Saf
ABSTRACT Background Digital databases such as pharmacovigilance (PV) databases could provide unique opportunities to monitor trends in suspected antibiotic resistance, ineffectiveness, and misuse, extending beyond their traditional role of tracking adverse drug reactions (ADRs).
Saleh H, Mitchell J, Lundborg CS, Sharma M.   +3 more
europepmc   +2 more sources

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   +2 more sources

Real-world data for golimumab treatment in patients with ulcerative colitis in Japan: interim analysis in post-marketing surveillance [PDF]

Intestinal Research, 2022
Background/Aims Golimumab (GLM) is an anti-tumor necrosis factor-α drug approved for treating moderate-to-severe active ulcerative colitis (UC). A 52-week post-marketing surveillance (PMS) was initiated to evaluate its safety and effectiveness in ...
Shiro Nakamura, Teita Asano, Hiroaki Tsuchiya, Kanami Sugimoto, Yuya Imai, Seiji Yokoyama, Yasuo Suzuki   +6 more
doaj   +1 more source