A report published as a research letter in Circulation: Cardiovascular Quality Outcomes, mapped out patterns in valsartan-associated adverse events (AEs) reported to the FDA’s Adverse Events Reporting System (FAERS). Investigators focused on reports to FAERS from January 1, 2017, to December 31, 2018, and calculated a reporting odds ratio (ROR), which captures the proportion of all reported adverse events (AEs) that were said to be neoplasms.
The letter notes that the number of AERS reports has increased from 1.9 in June 2019, just prior to the recall, to 15.4 in July and 18.2 in August before beginning to decline.
Read more here: https://www.tctmd.com/news/sudden-biologically-implausible-rise-valsartan-linked-neoplasms-after-2018-recall
What the report fails to note is that many doctors did not link any cancer to the recalled lots. Could the cancer be the culprit? Adverse event reports are helpful but under used. Helps keep companies on their toes (in our opinion).
