FAERS - Federal Adverse Events Reporting System
Hello kava lovers! It’s been a while, but life is starting to let up a bit, the shadows are getting longer, and the daytime temps are starting to fall. That means more time for more kava research!
Today’s information is going to come from the FDA’s adverse event reporting system known as FAERS (Formerly AERS). FAERS stands for “Federal Adverse Event Reporting System”. This system was formally started in 1969 with a major revision in 1997. Currently FAERS is the largest repository for spontaneously reported adverse events in the world with over 4 million public reports [1]. The FAERS database is very useful for analyzing associations with drug and herbal interactions; however some shortcomings should be acknowledged.
You can follow along with today’s fact of the day as all of this information is publicly available by default.
Launch the FAERS Public Dashboard using these steps:
If you’ve followed the directions above you’re now met with the FAERS reports for kava. The reports marked with Ropinirole and Haloperidol have several duplicates in this data set, so keep that in mind. The most recent report from March of 2020 we saw unfold almost in real time. On reddit we had a user who reported not being able to walk after visiting the kava bar and checked themselves into a hospital. All the data matches up to the person in question in the report. We’re pretty sure this coincides with report number 17538320.
To get some reference on how harmful some things can be, try searching “Acetaminophen”. It’s quite sobering. Acetaminophen (APAP, Panadol, Tylenol) currently has 8,351 adverse events for the year of 2021 with almost 13,000 for 2020.
There we go. You now know exactly how to see adverse events reports related to herbs and drugs in regards to the public and the FDA.
[1] Sakaeda, Toshiyuki, Akiko Tamon, Kaori Kadoyama, and Yasushi Okuno. 2013. “Data Mining of the Public Version of the FDA Adverse Event Reporting System.” International Journal of Medical Sciences 10 (7): 796–803. https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3689877/
[2] Center for Drug Evaluation, and Research. 2021. “FDA Adverse Event Reporting System (FAERS) Public Dashboard.” April 3, 2021. https://www.fda.gov/drugs/questions...event-reporting-system-faers-public-dashboard
Hello kava lovers! It’s been a while, but life is starting to let up a bit, the shadows are getting longer, and the daytime temps are starting to fall. That means more time for more kava research!
Today’s information is going to come from the FDA’s adverse event reporting system known as FAERS (Formerly AERS). FAERS stands for “Federal Adverse Event Reporting System”. This system was formally started in 1969 with a major revision in 1997. Currently FAERS is the largest repository for spontaneously reported adverse events in the world with over 4 million public reports [1]. The FAERS database is very useful for analyzing associations with drug and herbal interactions; however some shortcomings should be acknowledged.
- Duplicates and incomplete reports exist in the system. You’ll see this clearly if you scroll down the events list, as many of them have the same source document, indicating they’re from the same instance, just listed several times.
- Just because these reports exist, they don’t establish causation.
- Information in these reports is not independently verified.
- Rates of occurrence of these instances cannot be established with reports [2].
You can follow along with today’s fact of the day as all of this information is publicly available by default.
Launch the FAERS Public Dashboard using these steps:
- https://www.fda.gov/drugs/questions...event-reporting-system-faers-public-dashboard
- Click The blue button titled “FAERS Public Dashboard”
- Some black circles appear as the page loads, and you’re met with a disclaimer. Click “I have read” and click “Accept”.
- On the top left next to “Home” click “Search”
- Type “Kava” in the search bar, and then click “Go”
- Click “listing of cases” on the top blue bar.
If you’ve followed the directions above you’re now met with the FAERS reports for kava. The reports marked with Ropinirole and Haloperidol have several duplicates in this data set, so keep that in mind. The most recent report from March of 2020 we saw unfold almost in real time. On reddit we had a user who reported not being able to walk after visiting the kava bar and checked themselves into a hospital. All the data matches up to the person in question in the report. We’re pretty sure this coincides with report number 17538320.
To get some reference on how harmful some things can be, try searching “Acetaminophen”. It’s quite sobering. Acetaminophen (APAP, Panadol, Tylenol) currently has 8,351 adverse events for the year of 2021 with almost 13,000 for 2020.
There we go. You now know exactly how to see adverse events reports related to herbs and drugs in regards to the public and the FDA.
[1] Sakaeda, Toshiyuki, Akiko Tamon, Kaori Kadoyama, and Yasushi Okuno. 2013. “Data Mining of the Public Version of the FDA Adverse Event Reporting System.” International Journal of Medical Sciences 10 (7): 796–803. https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3689877/
[2] Center for Drug Evaluation, and Research. 2021. “FDA Adverse Event Reporting System (FAERS) Public Dashboard.” April 3, 2021. https://www.fda.gov/drugs/questions...event-reporting-system-faers-public-dashboard