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| http://dx.doi.org/10.1136/bmj.326.7391.712/a | DOI Listing |
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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
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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.
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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).
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Department of Pharmacy Practice, Auburn University Harrison College of Pharmacy, Auburn, AL 36049, United States.
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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
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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.
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ACTIVE POST-MARKETING SAFETY SURVEILLANCE OF NIRSEVIMAB ADMINISTERED TO CHILDREN IN WESTERN AUSTRALIA, APRIL-JULY 2024.
Pediatr Infect Dis J
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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.
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