05-01-2020, 04:08 PM
IF you want some insight into the way the FDA works up a safety signal, read this document:
https://www.fda.gov/media/137475/downloa...rce=Eloqua
If you go to table 1, attachment 1, it lists all the ways FDA can lead to the FDA opening a signal work-up (what they call a newly identified safety signal or NISS). However, even after a signal is identified, there is a long road before it can be confirmed or refuted.
I am sure, however, that the FDA has someone combing through the COVID data looking to see if any medications put patients at increased risk of bad outcomes.
If you are really curious, the FDA makes their dashboard of publicly reported adverse drug reactions available here:
https://fis.fda.gov/sense/app/d10be6bb-4...e/analysis
Unfortunately, COVID-19 is too new of a diagnosis to have entered the adverse event dictionary (new versions of the dictionary come out every six months, in May and November; the May edition will have COVID-19 as an event term). But, filtering in 2020, there have been 366 reports (312 serious, and 34 deadly) of either "coronavirus test positive" or "coronavirus infection" reported to the FDA. The tools available to the FDA epidemiologists are much more robust, and they are able to perform disproportionality analyses and keep a running tally of whether some drugs are over-represented in reports, such that they can initiate a more robust signal work-up once a certain drug/event pair reaches a predetermined level of significance.
BC
https://www.fda.gov/media/137475/downloa...rce=Eloqua
If you go to table 1, attachment 1, it lists all the ways FDA can lead to the FDA opening a signal work-up (what they call a newly identified safety signal or NISS). However, even after a signal is identified, there is a long road before it can be confirmed or refuted.
I am sure, however, that the FDA has someone combing through the COVID data looking to see if any medications put patients at increased risk of bad outcomes.
If you are really curious, the FDA makes their dashboard of publicly reported adverse drug reactions available here:
https://fis.fda.gov/sense/app/d10be6bb-4...e/analysis
Unfortunately, COVID-19 is too new of a diagnosis to have entered the adverse event dictionary (new versions of the dictionary come out every six months, in May and November; the May edition will have COVID-19 as an event term). But, filtering in 2020, there have been 366 reports (312 serious, and 34 deadly) of either "coronavirus test positive" or "coronavirus infection" reported to the FDA. The tools available to the FDA epidemiologists are much more robust, and they are able to perform disproportionality analyses and keep a running tally of whether some drugs are over-represented in reports, such that they can initiate a more robust signal work-up once a certain drug/event pair reaches a predetermined level of significance.
BC