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

Abstract

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.

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

Figure 1

Flow chart of the data analysis.

Figure 2

Timing and the number of AE report.

Figure 3

Significance analysis of SOCs.

Figure 4

Positive signals under positive SOCs.

Figure 5

Positive SOC signals in subgroup.

Figure 6

Top 20 positive AE signals in subgroup.

Figure 7

AE induce time of all reports.

Figure 8

AE induce time survival analysis.