Results 11 to 20 of about 3,641 (145)

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

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

Monitoring temporal changes in the specificity of an oral HIV test: a novel application for use in postmarketing surveillance. [PDF]

PLoS ONE, 2010
BackgroundPostmarketing surveillance is routinely conducted to monitor performance of pharmaceuticals and testing devices in the marketplace. However, these surveillance methods are often done retrospectively and, as a result, are not designed to detect ...
Joseph R Egger, Kevin J Konty, Jessica M Borrelli, Julia Cummiskey, Susan Blank   +4 more
doaj   +1 more source

Safety and Effectiveness of Empagliflozin in Korean Patients with Type 2 Diabetes Mellitus: Results from a Nationwide Post-Marketing Surveillance [PDF]

Diabetes & Metabolism Journal, 2023
Background To evaluate the safety and effectiveness of empagliflozin in routine clinical settings, we collected and assessed the clinical profiles of Korean patients with type 2 diabetes mellitus.
Jun Sung Moon, Nam Hoon Kim, Jin Oh Na, Jae Hyoung Cho, In-Kyung Jeong, Soon Hee Lee, Ji-Oh Mok, Nan Hee Kim, Dong Jin Chung, Jinhong Cho, Dong Woo Lee, Sun Woo Lee, Kyu Chang Won   +12 more
doaj   +1 more source

Uncovering Knowledge Gaps in the Safety Profile of Antiangiogenic Drugs in Cancer Patients: Insights from Spontaneous Reporting Systems Studies

Pharmaceuticals, 2023
Global repositories of postmarketing safety reports improve understanding of real-life drug toxicities, often not observed in clinical trials. The aim of this scoping review was to map the evidence from spontaneous reporting systems studies (SRSs) of ...
Valerio Ciccone, Marina Ziche, Andrea Spini, Sandra Donnini   +3 more
doaj   +1 more source

Real-World Use of Generic Meropenem: Results of an Observational Study

Antibiotics, 2021
Background: To determine the therapeutic effect and tolerability of meropenem in routine clinical practice, in terms of clinical and microbiological response.
Santiago Garnica-Velandia, Luz Adriana Aristizábal-Ruiz, Carlos Arturo Alvarez-Moreno   +2 more
doaj   +1 more source

Safety and effectiveness of edoxaban in Japanese patients with nonvalvular atrial fibrillation: Final report of a two‐year postmarketing surveillance study (ETNA‐AF‐Japan)

Journal of Arrhythmia, 2021
Background Direct oral anticoagulants (DOACs) are the recommended first‐line therapy for ischemic stroke prevention in patients with nonvalvular atrial fibrillation (NVAF).
Takeshi Yamashita, Yukihiro Koretsune, Tomoko Nagao, Kazuhito Shiosakai   +3 more
doaj   +1 more source

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 ...
openaire   +2 more sources