Here's some background on the FDA Adverse Event Reporting System (FAERS)
These outcomes fall into the following (non-mutually exclusive) categories:
- congenital anomaly
- required intervention to prevent permanent impairment
- other (serious outcome)
After late 2010, the # of serious outcomes begins to lag the # of reports, which indicates one of three things:
- The increase in the # of FAERS reports submitted over the past six years is mostly due to an increase in submission of reports w/ non-serious outcomes.
- The increase in the # of FAERS reports submitted over the past six year is mostly due to an increase in submission of reports w/ unknown outcomes.
- Some combination of points 1 and 2.
Data and code are here: https://github.com/pdanese/faers_counts_Q3_2016
Below is a slightly different way to view the same information.
The plot shows the ratio of serious patient outcomes to the number of reports filed per quarter. You can see that in the "early 2000s" the number of serious outcomes per report was around 1, but it has dropped in recent years 0.6 to 0.8 range. So, about 20 -- 40% of the FAERS reports since late 2012 do not report a serious outcome.