Adverse events associated with use of immunoglobulin in pediatric patients reported to the US Food and Drug Administration Adverse Event Reporting System, 2001-2023. [PDF]
Pediatr Allergy ImmunolAbstract Background Immunoglobulin products are widely used for the treatment of immunodeficiency and autoimmune disorders. Although clinical trials have demonstrated their efficacy and tolerability, data describing their postmarketing safety profile in pediatric populations remain limited, particularly regarding rare and serious adverse events.
Wei S +4 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 OutcomesThere 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
Age-Dependent Differences in Canakinumab Safety: A Comprehensive Pharmacovigilance Analysis Using the FAERS Database. [PDF]
Pharmacol Res PerspectABSTRACT While the efficacy of canakinumab, an anti‐interleukin‐1β monoclonal antibody, is well‐established, its safety profile, particularly across different age groups, remains inadequately explored. Using the FDA Adverse Event Reporting System (FAERS) database, this study evaluated postmarketing safety by analyzing adverse event (AE) reports from ...
Wang Y, Lam N, Huang X, Jiao Y.
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 +6 more
doaj +1 more source
Postmarketing surveillance Is not used to promote products [PDF]
BMJ, 1994 EDITOR, - Simon Voss and Fiona Harris's concerns about postmarketing surveillance need to be challenged.1 Without producing any evidence the authors imply deceit by pharmaceutical companies in three ways: firstly, by using “so called” independent research companies that do not acknowledge their link with the pharmaceutical companies; secondly, by using
M Vandenburg, W H Inman
openaire +2 more sources
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 +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 +12 more
doaj +1 more source
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 +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 +2 more
doaj +1 more source
Stepwise approach of development of dermo‐cosmetic products in healthy and atopic dermatitis paediatric population: safety evaluation, clinical development and postmarket surveillance [PDF]
Journal of the European Academy of Dermatology and Venereology, 2019 AbstractBackground/objectivesPaediatric skin, considered sensitive, and infant skin, more susceptible to percutaneous toxicity, require specially formulated cosmetic products. As recently shown, early use of emollients in infants “at risk” of developing atopic dermatitis has shown controversial results in reducing the incidence of atopic dermatitis ...
V. Ribet +5 more
openaire +2 more sources