Analysis of post-market adverse events of tafamidis base on the FDA adverse event reporting system.

Publisher: Nature Publishing Group Country of Publication: England NLM ID: 101563288 Publication Model: Electronic Cited Medium: Internet ISSN: 2045-2322 (Electronic) Linking ISSN: 20452322 NLM ISO Abbreviation: Sci Rep Subsets: MEDLINE

Original Publication: London : Nature Publishing Group, copyright 2011-

United States Food and Drug Administration* ; Adverse Drug Reaction Reporting Systems* ; Benzoxazoles*/adverse effects; United States ; Humans ; Amyloid Neuropathies, Familial ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Product Surveillance, Postmarketing ; Male

Tafamidis is the world's first and only oral drug approved to treat the rare disease transthyretin amyloid cardiomyopathy (ATTR-CM). Medicines are known to have different adverse reactions during the course of treatment. However, the current limited clinical studies did not identify significant adverse drug reactions to tafamidis. Tafamidis has been on the market for 5 years now, a large number of adverse drug event (ADE) reports with tafamidis as the primary suspected drug have been reported in the United Food and Drug Administration's adverse event reporting system (FAERS). We retrieved 8170 adverse event reports in FAERS with tafamidis as the first suspected drug, and mined these reports for positive signals to perform risk warnings for potentially possible adverse events with tafamidis. We found that a large number of adverse events associated with the primary disease were reported due to insufficient awareness of ATTR among the reporters, leading to a large number of positive signals reported in the cardiac disorders system. We also found that tafamidis has the potential to cause an adverse event risks of ear and labyrinth disorders system and urinary tract infection bacterial, which deserve continued clinical attention.
(© 2024. The Author(s).)

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No. FZX2019-06-01 Yunnan Provincial Cardiovascular Disease Clinical Medical Center Project; 2024J0263 Scientific Research Fund Project of Yunnan Provincial Education Department

Keywords: Adverse event; Amyloid cardiomyopathy; Pharmacovigilance; Real-world data-mining; Tafamidis

8FG9H9D31J (tafamidis)
0 (Benzoxazoles)

Amyloidosis, Hereditary, Transthyretin-Related

Date Created: 20240613 Date Completed: 20240613 Latest Revision: 20240616

20240616

PMC11176370

10.1038/s41598-024-64697-y

38871835