Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1080/01947648.2013.800797 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Death incidents following transcatheter edge-to-edge repair (TEER) with the MitraClip device: analysis of 10-years post-marketing death reports from the Manufacturer and User Facility Device Experience (MAUDE) registry.
BMC Cardiovasc Disord
January 2025
Department of Cardiology, Peking University International Hospital, Life Park Road No.1, Life Science Park of Zhongguancun, Chang Ping District, Beijing, 102206, China.
Background: The transcatheter edge-to-edge repair (TEER) technique, facilitated by the MitraClip device, is a minimally invasive intervention designed for high-risk patients with mitral regurgitation (MR). This study conducts a retrospective analysis of death events associated with MitraClip implantation over a ten-year decade, utilizing data from the FDA's Manufacturer and User Facility Device Experience (MAUDE) database to evaluate trends in safety outcomes.
Methods: A comprehensive search of the publicly accessible MAUDE database was conducted to retrieve reports of deaths and injuries related to MitraClip implantation from October 2013 to September 2023.
Multi-Stakeholder Call to Action for the Future of Vaccine Post-Marketing Monitoring: Proceedings from the First Beyond COVID-19 Monitoring Excellence (BeCOME) Conference.
Drug Saf
January 2025
Pfizer (Worldwide Medical & Safety), New York, NY, USA.
Post-marketing safety of antiseizure medications: Focus on serious adverse effects including drug reaction with eosinophilia and systemic symptoms (DRESS).
Seizure
January 2025
Department of Pharmacy Practice, Auburn University Harrison College of Pharmacy, Auburn, AL 36049, United States.
Purpose: On November 28, 2023, the U.S. FDA issued a Drug Safety Communication, warning that antiseizure medications (ASMs) levetiracetam and clobazam can cause a rare but serious reaction, drug reaction with eosinophilia and systemic symptoms (DRESS).
View Article and Find Full Text PDFPost-marketing safety concerns with lecanemab: a pharmacovigilance study based on the FDA Adverse Event Reporting System database.
Alzheimers Res Ther
January 2025
Department of Pharmacy, Xuanwu Hospital of Capital Medical University, No. 45, Changchun Street, Xicheng District, Beijing, 100053, People's Republic of China.
Background: The safety data of lecanemab in the post-marketing period has yet to be fully investigated in the current literature. We aimed to identify and characterise the safety profile of lecanemab in the post-marketing period.
Methods: We searched and reviewed the reports submitted to the FDA's Adverse Event Reporting System (FAERS).
ACTIVE POST-MARKETING SAFETY SURVEILLANCE OF NIRSEVIMAB ADMINISTERED TO CHILDREN IN WESTERN AUSTRALIA, APRIL-JULY 2024.
Pediatr Infect Dis J
January 2025
From the Communicable Disease Control Directorate, Western Australia Department of Health, Perth, Western Australia, Australia.
Children receiving nirsevimab were texted a link to an online survey to monitor adverse events following immunization. Total of 4340 parents received the link, which 1195 (27.5%) responded.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!