Safety of Gadopiclenol After Its First Year of Clinical Use
Year: 2024
Type: article
Study design: Observational Study
Abstract: ABSTRACT: Gadopiclenol is a novel, macrocyclic high-relaxivity gadolinium-based contrast agent recently approved for use in magnetic resonance imaging of the central nervous system and body organs at a dose of 0.05 mmol/kg body weight. Postmarketing surveillance of its first year of clinical use in the United States of America showed no serious adverse events (AEs) following over 882,550 administrations and a very low rate of nonserious AEs (1 case every 27,580 exposures). The types of observed AEs were similar to those reported for other gadolinium-based contrast agents in clinical use. Safety data from postmarketing surveillance of gadopiclenol further confirm its positive benefit-risk profile demonstrated in preapproval clinical studies.
Source: Investigative Radiology
Authors: Alberto Spinazzi, Eric Lancelot, Letizia Vitali, Christophe Cot, Gianpaolo Pirovano, Alvin Joseph, Miles A. Kirchin, Elisabeth Darmon-Kern, Philippe Bourrinet
Institutions: Guerbet (France), Bracco (Italy)
Language: English
Subfield: Toxicology
Domain: Life Sciences
Open Access status: hybrid
OpenAlex ID: W4404582623