FDA Adverse Events Reporting System (FAERS)

Nov 16, 2017
Bart Cobert

Pharmacovigilance, Drug Safety and Regulatory Affairs Author & Expert

As is well known in the PV world, FDA operates one of the largest and most complete databases of adverse events (both serious and non-serious) on drugs marketed in the US.

FAERS

For decades, FAERS and its predecessor databases, including the earlier incarnation called AERS, has been available in a very user unfriendly manner. It included downloading quarterly updates and loading them into a user created database. Now, following the UK, Canada, and others, FDA has made FAERS data easily available on-line in a fairly user friendly manner.

One can now obtain fairly detailed information on AEs immediately.  This is the link for the opening page for FAERS.

This page covers the limitations of the data which include: duplicate and incomplete reports, information that is not necessarily medically verified, no denominators (total users of the drug) preventing the calculation of rates of occurrence. In addition, FDA notes that the existence of the report does not establish causality. FDA summarizes this by noting: “Importantly, the FAERS data by themselves are not an indicator of the safety profile of the drug or biologic”.

 

FAERS Public Dashboard

At the bottom of the page is a link which gets you to the FDA FAERS Dashboard.  A disclaimer screen pops up when you go there which summarizes the caveats noted on the opening page. One must click “accept” this to get access to the database.

The home page of the FAERS Public Dashboard has a summary of the total reports, serious reports and deaths at the top of the page.  These seem to change periodically   as new cases enter the database. As of this writing (November 2017) the totals through August 31, 2017 are:

 

There is also a very interesting interactive summary table of the total reports as well as the expedited (serious) and non-expedited (serious and some non-serious) reports as well as a graph.

Note that BSR=Biologic safety reports; Direct =Sent to FDA directly not reported from the NDA holder, sponsor etc.

 

As one can see the total number of cases has skyrocketed from 129,000 in 1994 to a projected nearly 2 million in 2017 and expedited reports from 22,000 to a projected 900,000 in 2017.

As noted, if you click on the boxes Year and Category you can get further information on each of these categories. The number of direct reports to FDA has risen from 20,000 in 2006 to a projected 60,000 in 2017.

If you click on the box “Reports by Report Type” you can sort the reports by reporter, reporter region and seriousness. Here is the seriousness sort:

In 2016 (for the full year) we had 40,000 serious reports of which shows the cases received where a seriousness criterion was checked (e.g. hospitalization, life-threatening etc.). Note that many serious cases come to FDA via periodic reports (PADERs or PSURs) without a seriousness type noted. The total deaths in 2016 was about 1900.

 

At the top of this page is a search box marked “Search for Products.” Clicking on this brings a search box where one can search on brand or generic names. Searching on “loratadine” (an anti-histamine) gives the demographic chart:

 

At the top in blue are several other buttons.  For “Reaction Group”:

Here we see the SOC groups sorted by age. Note that on this graphic the left hand chart is truncated. On the site one can scroll down for the rest of the SOCs not shown here. One can also search using the box on the top right for age group, sex, reporter and reporter region (US vs foreign) and several other variable by clicking on the boxes.

 

Clicking on the “Reaction” button on top of the page shows:

 

This page is similar to the previous one but note the little “+” sign on the left of each category. Clicking this gives you the specific AEs now found on the right side of the table. Clicking on one will give you the actual numbers for an individual AE or for several grouped together.  For nausea and vomiting under GI disorders:

Note here that on top it is noted that there were ten deaths. This is an example of one of the limitations of the data search. It’s unlikely that nausea and vomiting alone caused these deaths. Rather it is likely there were several other serious AEs in each of these patients that led to death. So one must keep in mind that that these outcomes relate to the “whole patient” who probably had other medical problems and SAEs.

 

 

Finally, clicking on the “Listing of Cases” gives you a line listing of up to some 20 columns (from the MedWatch form) for each case. One needs a big screen or one must scroll to see all the fields. Note the three dots on the far right bottom. Clicking on this lets one choose which of the 20 or so fields to view.  Note the case ID number is in the first column. One can thus request through FOI the MedWatch form as we do now but more laboriously.

 

 

Each column is searchable singly or in combination.  So one can look for specifics: women, received date, age etc.  Here is a search on the above for female and death:

Bottom Line

At long last we can now search on FAERS in a fairly user friendly manner.  Have a go at it and play with all the buttons.  It actually is a quite powerful search engine and you can drill down on cases.  This should help in signaling. There are some limitations.  I could not search on groups of drugs, say, loratadine and Benedryl or all anti-histamines.  Perhaps there is a way but I could not figure it out.

In any case, use this tool.  It is very helpful.  Thank you FDA!

 

 

Tags: , , ,