FDA Updates Reporting of Adverse Events

This week, the FDA updated its quarterly reporting on adverse events. It is a bit of a complicated mess to work your way through. But there are other ways to look at adverse events and given that there have recently been a few drugs experiencing well-publicized adverse events, it seemed like a good subject to explore.

The FDA has a Freedom of Information Act [FOIA] office that processes requests for information. Among the information that can be requested is a printout of the adverse events for a particular drug, or even those related to a particular company. When submitting a FOIA, you can specify any parameters. The only thing you have to do is (1) be patient - it used to take about 6 weeks, but it does vary, and (2) pay for it, but it is not exorbitant and price depends on how lengthy your research is. Depending on what you ask for, you also may need storage - the reports are computer sheet printouts that can go on for pages, so be careful what parameters you choose. If you choose too broadly, you can wind up with a LOT of unwanted information and paper.